CancerEatWellNCT04947150
Optimizing an mHealth Intervention to Change Food Purchasing Behaviors for Cancer Prevention
A study testing Location-triggered notification, Reflections on benefits of change and Coach monitoring in people with Cancer, run by Drexel University at 1 site in United States.
Trial summary
Dietary intake is a powerful, modifiable factor that influences cancer risk. Unfortunately, most adults in the U.S. find it difficult to adhere to dietary guidelines for cancer prevention. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Location-triggered notification, Reflections on benefits of change and Coach monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 29 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Fluent in English
- Low adherence to cancer prevention dietary guidelines, operationalized as a score of ≤ 2 out of 4 using the National Cancer Institute method for assessing adherence to World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) lifestyle recommendations. This three-level scoring system (meeting/partially meeting/not meeting each recommendation) includes 4 items specific to diet. Participants must score equal or less than 2, meaning that they are fully meeting recommendations for no more than 2 of the 4 dietary recommendations.
- Performs the majority of the household's food shopping, and do so at stores that can passively stream item-level data from a store loyalty card to the Information Machine API (e.g., Walmart, Target, ShopRite, Wegman's, etc.)
- Has a smartphone with iOS or Android operating system that is compatible with the program app
- Lives in a household with at least one other adult who consents to being randomized to possibly receive messages on his/her own cell phone through the program app
Who cannot join
- Medical condition or psychiatric condition (e.g., active substance abuse, eating disorder) that may limit appropriateness of or ability to comply with program dietary recommendations
- Planning to enroll in another lifestyle modification program in the next 6 months
- Bariatric surgery history
- Currently pregnant or breastfeeding or planning to become pregnant in the next 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Dietary intake is a powerful, modifiable factor that influences cancer risk. Unfortunately, most adults in the U.S. find it difficult to adhere to dietary guidelines for cancer prevention. One promising pathway for improving dietary adherence is to target grocery shopping habits, i.e., foods purchased for consumption at home. Two-thirds of daily food intake is sourced from or eaten in the home, so improving the quality of the home food environment should improve overall diet quality. When healthy foods are purchased and unhealthy foods are not, minimal self-control is needed to make healthy eating choices in the home. At the point of purchase, it is difficult to resist the temptation of palatable foods, but interventions might facilitate healthy choices by promoting dietary goal salience in real-time while grocery shopping, enhancing motivation to make and sustain changes to the diet, and increasing household support and accountability for healthy food purchasing. The proposed study will enroll adults who have low adherence to cancer prevention dietary recommendations. All participants will attend a nutrition education workshop conducted via Zoom. For 20 weeks, all participants also will receive once weekly reminders and recommendations for food purchasing via an app. The study will experimentally test four additional intervention components: location-triggered messages, coaching monitoring of food purchases, benefit of change content, and household member involvement. The preliminary aim of the study is to assess feasibility and acceptability of the intervention components. The primary aim of the study is to quantify the effect of each intervention component, individually and in combination, on dietary intake (assessed with 24-hour food recalls). The overarching goal of this project is to optimize this mHealth intervention, which can be tested in the future in a fully powered clinical trial.
- Conditions
- Cancer
- Being tested
- Location-triggered notification, Reflections on benefits of change, Coach monitoring, Household support
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Location-triggered notificationBehavioural
If participants are randomized to have this component ON, the app will send the notification when the participant's smartphone is within a 50-meter "geofence" around designated grocery stores. No more than one notification will be sent per week. Mindfulness of program goals in the moment of decision making is expected to facilitate program-consistent food purchasing behaviors. Participants assigned to have location-triggered message delivery OFF will receive their weekly "recommendations and reminders" messages at standard times throughout the week. The content of the messages will not differ according to whether this component is ON vs. OFF.
Reflections on benefits of changeBehavioural
Participants will reflect on anticipated benefits of purchasing healthy foods, consistent with motivational interviewing and self-determination theory. Message content will be personalized as follows: During the initial workshop, all participants will complete an exercise identifying benefits of healthy eating that are important to them. Message content will then be programmed to be personalized according to anticipated rewards important to that participant. Participants assigned to have this intervention component OFF will not have content about anticipated benefits of change added to any messages.
Coach monitoringBehavioural
Coaches will monitor participant food purchases via a dashboard for viewing purchase data, and send messages designed to provide feedback and enhance supportive accountability for program goals. The messages will provide reinforcement for purchases consistent with program goals and express concern for areas in which adherence is low. Participants assigned to have this component OFF will not receive these extra messages or phone calls, and their food purchases will only be viewed by research staff for research outcome assessment purposes.
Household supportBehavioural
If participants are assigned to have household support ON, one adult in the household will receive weekly text messages designed to elicit support for changing food purchases. In addition, the index participant and household member will be invited to participate in one extra workshop session and three brief coaching calls focused on household support. If participants are assigned to have this OFF, household members will have no program involvement.
| Study group | Role | What they receive |
|---|---|---|
| LOCATION TRIGGERED MESSAGING | Experimental | Weekly message is triggered when arriving at grocery store. Receives: Behavioral: Location-triggered notification |
| COACH MONITORING | Experimental | Coaches view grocery purchases via web portal, send weekly messages about purchases they observe, and conduct three brief phone calls to discuss purchases. Receives: Behavioral: Coach monitoring |
| BENEFITS OF CHANGE | Experimental | Attend an extra workshop session and three phone calls to identify and reflect on benefits of dietary change. Content added to standard weekly messages about benefits of change. Receives: Behavioral: Reflections on benefits of change |
| HOUSEHOLD SUPPORT | Experimental | An adult household member attends one workshop session and three phone calls with the index participant. This household member receives weekly text messages for 20 weeks about program goals and ways to support the index participant. Receives: Behavioral: Household support |
What is being measured
The primary outcome is the main question the study is designed to answer.
1a. Dietary Intake: ASA24 (Fiber)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in grams of fiber per day.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: Baseline and post-treatment (0 and 20 weeks)
1b. Primary Outcome: Dietary Intake ASA24 (Fruit/Veg)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in number of cups of fruits and vegetables per day.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: Baseline and post-treatment (0 and 20 weeks)
1c. Primary Outcome: Dietary Intake ASA24 (Red Meat)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in ounces of red meat consumed per week.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: Baseline and post-treatment (0 and 20 weeks)
1d. Primary Outcome: Dietary Intake ASA24 (Processed Meat)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in ounces of processed meat consumed per week.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: Baseline and post-treatment (0 and 20 weeks)
1e. Primary Outcome: Dietary Intake ASA24 (Added Sugars)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in grams of added sugars consumed per day.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: Baseline and post-treatment (0 and 20 weeks)
1f. Primary Outcome: Dietary Intake ASA24 (Sodium)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in mg of sodium consumed per day.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: Baseline and post-treatment (0 and 20 weeks)
1g. Primary Outcome: Dietary Intake ASA24 (Fat)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in grams of saturated fat consumed per day.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: Baseline and post-treatment (0 and 20 weeks)
1h. Primary Outcome: Dietary Intake ASA24 (Sugar-Sweetened Beverages)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in oz of sugar sweetened beverages consumed per day.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: Baseline and post-treatment (0 and 20 weeks)
2a: Dietary Intake: DHQ-III (Fiber)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in grams of fiber per day.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: Baseline and post-treatment (0 and 20 weeks)
2b. Dietary Intake: DHQ-III (Fruits/Veg)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in cups of fruits and vegetables per day.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: Baseline and post-treatment (0 and 20 weeks)
2c. Dietary Intake: DHQ-III (Red Meat)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in oz of red meat consumed per week.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: Baseline and post-treatment (0 and 20 weeks)
2d. Dietary Intake: DHQ-III (Processed Meat)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in oz of processed meat consumed per week.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: Baseline and post-treatment (0 and 20 weeks)
2e. Dietary Intake: DHQ-III (Added Sugars)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in grams of added sugars consumed per day.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: Baseline and post-treatment (0 and 20 weeks)
2f. Dietary Intake: DHQ-III (Sodium)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in mg of sodium consumed per day.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: Baseline and post-treatment (0 and 20 weeks)
2g. Dietary Intake: DHQ-III (Fat)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in grams of saturated fat per day.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: Baseline and post-treatment (0 and 20 weeks)
2h. Dietary Intake: DHQ-III (Sugar-Sweetened Beverages)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in ounces of sugar-sweetened beverages per day.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: Baseline and post-treatment (0 and 20 weeks)
Secondary outcomes (24)
Goal Salience
Goal salience while grocery shopping was measured using an investigator-developed self-report questionnaire. Participants rated 3 questions pertaining to salience of health goals during grocery shopping on a sliding scale from 0 (not at all) to 100 (very much): Scores on these three items were averaged to compute a global Goal Salience total score (range = 0-100), with higher scores indicating higher goal salience.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: 0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Supportive Accountability
Supportive accountability was measured using 5 items adapted from the Perceptions of Accountability Scale (Chhabria et al., 2020). Participants rated 5 items (e.g., "I feel accountable to others for meeting my dietary goals") on a sliding scale from 0 (not at all) to 100 (very much). Scores on the 5 items were averaged to produce a global Supportive Accountability total score (range 0-100), with higher scores indicating higher perceived supportive accountability to others for dietary/healthy eating goals.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: 0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Autonomous Motivation
Motivation for healthy eating was measured using 10 items adapted from the Treatment Self-Regulation Questionnaire (Levesque et al., 2007). Using the question stem "The reason I would follow a healthy diet is...", participants rated items on a scale from 1 (not at all true) to 7 (very true). Six items were averaged to create a subscale of autonomous Motivation for healthy eating (range 1-7), with higher scores on each subscale indicated higher Autonomous Motivation.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: 0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
External Motivation
Motivation for healthy eating was measured using 10 items adapted from the Treatment Self-Regulation Questionnaire (Levesque et al., 2007). Using the question stem "The reason I would follow a healthy diet is...", participants rated items on a scale from 1 (not at all true) to 7 (very true). Four items were averaged to create the subscale of external Motivation for healthy eating (range 1-7). Higher scores on each subscale indicated higher external motivation for healthy eating.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: 0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Social Support (Encouragement)
Participants responded to 10 items adapted from the Sallis Social Support for Diet Questionnaire (Sallis et al., 1987). Using the question stem "The other adult(s) in my household...", participants rated items on a scale from 1 (none) to 5 (very often), with 6 indicating "Not Applicable" (N/A; recoded as 1). Five items were summed to measure encouragement of healthy eating (e.g., "complimented me on changing my eating habits"; range 5-25), with higher scores indicating higher encouragement. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: 0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Social Support (Discouragement)
Participants completed the Sallis Social Support for Diet Questionnaire (Sallis et al., 1987). Using the question stem "The other adult(s) in my household...", participants rated items on a scale from 1 (none) to 5 (very often). 6 indicated "Not Applicable," which was recoded as 1 (none). Five items (e.g., "ate unhealthy foods in front of me") were summed to create the Discouragement of Healthy Eating subscale (range 5-25); higher scores indicated higher discouragement.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: 0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Quality of Household Relationship
Quality of the household relationship was measured using 5 items adapted from the Relationship Assessment Scale (Hendrick, 1988). Items assessed the quality of their relationship with the person who served as their household support partner in the Eatwell program (e.g., "How well does this person meet your needs") on a scale from 1 (Low) to 5 (High). Scores on the 5 items were averaged to calculate a Relationship Quality total score (range 1-5); higher scores indicated higher perceived relationship quality.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: Baseline
Weight History
Weight history was measured using an investigator developed questionnaire. Participants answered the following question about weight history in the past 6 months: "Which of these statements best describe what has happened to your weight during the past 6 months?" Answer choices included: (1) My weight has stayed the same; (2) I've been losing weight; (3) I've been gaining weight; or (4) My weigh has fluctuated a lot.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: 0 weeks (Baseline)
Dietary Restraint
Dietary restraint was measured using the Three Factor Eating Questionnaire (Cappelleri et al., 2009). For items #1-20, participants rated statements on a 4-point Likert scale from 1 (definitely true) to 4 (definitely false; reverse coded). Item 21 assessed overall restraint on an 8-point scale from 1 (no restraint) to 8 (total restraint), recoded such that 1-2=1; 3-4=2; 5-6=3; and 7-8=4 (so that all items ranged 1-4). Six items were summed to calculate a Restraint score (range = 6-24); higher scores indicated more restraint.
This pilot study used a factorial design, with 16 conditions and ~4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: 0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Uncontrolled Eating
Uncontrolled eating was measured using the subscale of the Three Factor Eating Questionnaire - 21 item (Cappelleri et al., 2009). Responses ranged from 1 (definitely true) to 4 (definitely false). Items were reverse coded and summed to calculate an uncontrolled eating (range = 6-24), with higher scores indicating higher uncontrolled eating.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: 0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Emotional Eating
Emotional eating was measured using the subscale of the Three Factor Eating Questionnaire - 21 item (Cappelleri et al., 2009). Responses ranged from 1 (definitely true) to 4 (definitely false). Six were reverse coded and summed to calculate an emotional eating (range = 6-24), with higher scores indicating higher emotional eating.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: 0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Dietary Intake - FFQ (Guideline 1)
A 13-item Food Frequency Questionnaire was adapted from similar measures (Rifas-Shiman et al., 2001). To measure intake for guideline 1 (i.e., fruits, vegetables, whole grains, and bean/ legumes ), participants rated how frequently they consumed these categories (4 items) during an average week over the past month (0=Never, 1=less than once per week, 2=once per week, 3=2-4 times/week, 4=nearly daily/daily, 5=greater than twice per day). A total guideline 1 score was calculated as the average of responses to the 4 items (range 0-5), where higher scores indicate more frequently eating fruits, vegetables, whole grains, and beans/legumes. This study used a factorial design, with 16 conditions (with ~4 participants) and was designed to collapse across conditions (i.e., comparing 8 conditions where factor is ON to 8 OFF conditions). Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: 0, 10, 20 weeks
Dietary Intake - FFQ (Guideline 2)
A 13-item Food Frequency Questionnaire was adapted from similar measures (Rifas-Shiman et al., 2001). To measure intake for guideline 2 (i.e., processed foods high in fat, starches, sugars), participants rated how frequently they consumed foods from these categories (6 items) during an average week over the past month (0=Never, 1=less than once per week, 2=once per week, 3=2-4 times/week, 4=nearly daily/daily, 5=greater than twice per day). A total guideline 2 score was calculated as the average of responses to the 6 items (range 0-5), where higher scores indicate more frequently eating processed foods. This study used a factorial design, with 16 conditions (with ~4 participants) and was designed to collapse across conditions (i.e., comparing 8 conditions where factor is ON to 8 OFF conditions). Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: 0, 10, 20 weeks
Dietary Intake - FFQ (Guideline 3)
A 13-item Food Frequency Questionnaire was adapted from similar measures (Rifas-Shiman et al., 2001). To measure intake for guideline 3 (i.e., red and processed meat), participants rated how frequently they consumed these categories (2 items) during an average week over the past month (0=Never, 1=less than once per week, 2=once per week, 3=2-4 times/week, 4=nearly daily/daily, 5=greater than twice per day). A total guideline 3 score was calculated as the average of responses to the 2 items (range 0-5), where higher scores indicate more frequently eating red and processed meats. This study used a factorial design, with 16 conditions (with ~4 participants) and was designed to collapse across conditions (i.e., comparing 8 conditions where factor is ON to 8 OFF conditions). Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: 0, 10, 20 weeks
Dietary Intake - FFQ (Guideline 4)
A 13-item Food Frequency Questionnaire was adapted from similar measures (Rifas-Shiman et al., 2001). To measure intake for guideline 4 (i.e., sugar-sweetened drinks), participants rated how frequently they consumed these drinks (1 item) during an average week over the past month (0=Never, 1=less than once per week, 2=once per week, 3=2-4 times/week, 4=nearly daily/daily, 5=greater than twice per day). Given intake for guideline 4 was assessed with only 1 item on the FFQ, the total guideline 4 score was the response to this single item (range 0-5), where higher scores indicate more frequently drinking sugar-sweetened drinks. This study used a factorial design, with 16 conditions (with ~4 participants) and was designed to collapse across conditions (i.e., comparing 8 conditions where factor is ON to 8 OFF conditions). Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: 0, 10, 20 weeks
Treatment Acceptability: 10 Weeks
An adapted 8- item version of the Treatment Acceptability Questionnaire (Hunsley, 1993) was used to assess intervention acceptability. Eight questions probed their program experience and how helpful/acceptable they found various intervention components (e.g., "How effective do you think this program is?"). Responses ranged from 1 = no/low acceptability to 7 = high acceptability. A total score was calculated as the average across all 8 items (range 8-56) where higher scores indicate greater treatment acceptability.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: 10 weeks (mid-treatment)
Treatment Acceptability: 20 Weeks
An adapted 8- item version of the Treatment Acceptability Questionnaire (Hunsley, 1993) was used to assess intervention acceptability. Eight questions probed their program experience and how helpful/acceptable they found various intervention components (e.g., "How effective do you think this program is?"). Responses ranged from 1 = no/low acceptability to 7 = high acceptability. A total score was calculated as the average across all 8 items (range 8-56) where higher scores indicate greater treatment acceptability.
This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
Measured: 20 weeks (post-treatment)
Goals and Stages of Change- Household Member
Two self-report items developed by the investigator assessed the goals of the selected household member at baseline: "On a scale of 1-100, how important is it that you adopt healthier eating habits right now?". Item 2 asked "On a scale of 1-100, how important is it that you help your household member adopt healthier eating habits right now?". For each item, household members responded on a scale from 0 - not important at all, 50 - about as important as most of the other things I would like to achieve now, to 100 - most important thing in my life now. Items were analyzed at individually, and each item ranged 0-100 where higher scores indicate higher importance of the associated goal.
Measured: 0 weeks
Dietary Intake-household Member
Household members completed the same 13-item Food Frequency Questionnaire as the index participant (adapted from Rifas-Shiman et al., 2001) to measure dietary intake. Household members are presented with 13 categories of foods that are relevant for each of the cancer prevention dietary guidelines (e.g., "Fresh, frozen, or canned fruit (not dried or fruit juice)", "Red meats such as beef, pork, lamb"). They rated how frequently they consume each category during an average week over the past month. Scale is as follows: 0 = Never, 1 = less than per week, 2= once per week, 3 = 2-4 times per week, 4 = nearly daily or daily, 5 = greater than twice per day. The 13 items are then classified into the guideline they pertain to and total guidelines scores were calculated as the average of responses to all relevant items (range 0-5) where higher scores indicate more frequently eating items associated with that nutrition guideline.
Measured: 0, 20 weeks
Treatment Acceptability - Household
Household members completed the same adapted 8- item version of the Treatment Acceptability Questionnaire (Hunsley, 1993) as index participants. This measured acceptability of the intervention. Household members were presented with 8 questions about their experience during the program and how helpful/acceptable they found various intervention components to be (e.g., "How effective do you think this program is?", "How trustworthy do you think your coach was?". Household members responded to each question on a 7-point Likert scale where 1 = no/low acceptability and 7 = high acceptability. A total score was calculated as the average across all 8 items (range 8-56) where higher scores indicate greater treatment acceptability.
Measured: 20 weeks
Dietary Intake- Household Member - FFQ (Guideline 1)
Household members completed the same 13-item Food Frequency Questionnaire as the index participant (adapted from Rifas-Shiman et al., 2001) to measure dietary intake. To measure intake consistent with guideline 1 of the dietary cancer prevention guidelines (i.e., intake of fruits, vegetables, whole grains, and bean/ legumes ), household members rated how frequently they consumed these categories (4 items) during an average week over the past month. Scale was as follows: 0 = Never, 1 = less than once per week, 2= once per week, 3 = 2-4 times per week, 4 = nearly daily or daily, 5 = greater than twice per day. A total guideline 1 score was calculated as the average of responses to the 4 items (range 0-5), where higher scores indicate more frequently eating fruits, vegetables, whole grains, and beans/legumes.
Measured: 0, 20 weeks
Dietary Intake - Household Member - FFQ (Guideline 2)
Household members completed the same 13-item Food Frequency Questionnaire as the index participant (adapted from Rifas-Shiman et al., 2001) to measure dietary intake. To measure intake consistent with guideline 2 of the dietary cancer prevention guidelines (i.e., intake of processed foods high in fat, starches, or sugars), household members rated how frequently they consumed foods that fell into these categories (6 items) during an average week over the past month. Scale was as follows: 0 = Never, 1 = less than once per week, 2= once per week, 3 = 2-4 times per week, 4 = nearly daily or daily, 5 = greater than twice per day. A total guideline 2 score was calculated as the average of responses to the 6 items (range 0-5), where higher scores indicate more frequently eating processed foods high in far, starches, and sugars.
Measured: 0, 20 weeks
Dietary Intake-household Member - FFQ (Guideline 3)
Household members completed the same 13-item Food Frequency Questionnaire as the index participant (adapted from Rifas-Shiman et al., 2001) to measure dietary intake. To measure intake consistent with guideline 3 of the dietary cancer prevention guidelines (i.e., intake of red and processed meats), household members rated how frequently they consumed red meats and processed meats (2 items) during an average week over the past month. Scale was as follows: 0 = Never, 1 = less than once per week, 2= once per week, 3 = 2-4 times per week, 4 = nearly daily or daily, 5 = greater than twice per day. A total guideline 3 score was calculated as the average of responses to the 2 items (range 0-5), where higher scores indicate more frequently eating red and processed meats.
Measured: 0, 20 weeks
Dietary Intake-household Member - FFQ - Guideline 4
Household members completed the same 13-item Food Frequency Questionnaire as the index participant (adapted from Rifas-Shiman et al., 2001) to measure dietary intake. To measure intake consistent with guideline 4 of the dietary cancer prevention guidelines (i.e., intake of sugar sweetened beverages), household members rated how frequently they consumed sugar sweetened beverages (1 item) during an average week over the past month. Scale was as follows: 0 = Never, 1 = less than once per week, 2= once per week, 3 = 2-4 times per week, 4 = nearly daily or daily, 5 = greater than twice per day. A total guideline 4 score was calculated as the response to this item (range 0-5), where higher scores indicate more frequently drinking sugar sweetened beverages.
Measured: 0, 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Jun 2021
- Primary completion29 Mar 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is a 2x2x2x2 design. There are four factors, each with two levels: ON vs OFF.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Meghan Butryn, Drexel University
- Investigators
- Meghan L Butryn, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947150
- Sponsor's protocol ID
- 1R21CA252933
- Other IDs
- 1R21CA252933
- Acronym
- EatWell
- Status last verified
- Oct 2023
- First submitted
- 16 Jun 2021
- Last updated
- 10 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Butryn ML, Hagerman CJ, Crane NT, Ehmann MM, Forman EM, Milliron BJ, Simone NL. A Proof-of-Concept Pilot Test of a Behavioral Intervention to Improve Adherence to Dietary Recommendations for Cancer Prevention. Cancer Control. 2023 Jan-Dec;30:10732748231214122. doi: 10.1177/10732748231214122.
PubMed 37950612Horgan OZ, Crane NT, Forman EM, Milliron BJ, Simone NL, Zhang F, Butryn ML. Optimizing an mHealth Intervention to Change Food Purchasing Behaviors for Cancer Prevention: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 24;11(6):e39669. doi: 10.2196/39669.
PubMed 35749216
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing an mHealth Intervention to Change Food Purchasing Behaviors for Cancer Prevention
- ClinicalTrials.gov ID
- NCT04947150
- Acronym / sponsor ID
- EatWell / 1R21CA252933
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Posted 10 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dietary intake is a powerful, modifiable factor that influences cancer risk. Unfortunately, most adults in the U.S. find it difficult to adhere to dietary guidelines for cancer prevention. One promising pathway for improving dietary adherence is to target grocery shopping habits, i.e., foods purchased for consumption at home. Two-thirds of daily food intake is sourced from or eaten in the home, so improving the quality of the home food environment should improve overall diet quality. When healthy foods are purchased and unhealthy foods are not, minimal self-control is needed to make healthy eating choices in the home. At the point of purchase, it is difficult to resist the temptation of palatable foods, but interventions might facilitate healthy choices by promoting dietary goal salience in real-time while grocery shopping, enhancing motivation to make and sustain changes to the diet, and increasing household support and accountability for healthy food purchasing. The proposed study will enroll adults who have low adherence to cancer prevention dietary recommendations. All participants will attend a nutrition education workshop conducted via Zoom. For 20 weeks, all participants also will receive once weekly reminders and recommendations for food purchasing via an app. The study will experimentally test four additional intervention components: location-triggered messages, coaching monitoring of food purchases, benefit of change content, and household member involvement. The preliminary aim of the study is to assess feasibility and acceptability of the intervention components. The primary aim of the study is to quantify the effect of each intervention component, individually and in combination, on dietary intake (assessed with 24-hour food recalls). The overarching goal of this project is to optimize this mHealth intervention, which can be tested in the future in a fully powered clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- This is a 2x2x2x2 design. There are four factors, each with two levels: ON vs OFF.
| Arm | Type | Receives |
|---|---|---|
| LOCATION TRIGGERED MESSAGING | Experimental | Behavioral: Location-triggered notificationWeekly message is triggered when arriving at grocery store. |
| COACH MONITORING | Experimental | Behavioral: Coach monitoringCoaches view grocery purchases via web portal, send weekly messages about purchases they observe, and conduct three brief phone calls to discuss purchases. |
| BENEFITS OF CHANGE | Experimental | Behavioral: Reflections on benefits of changeAttend an extra workshop session and three phone calls to identify and reflect on benefits of dietary change. Content added to standard weekly messages about benefits of change. |
| HOUSEHOLD SUPPORT | Experimental | Behavioral: Household supportAn adult household member attends one workshop session and three phone calls with the index participant. This household member receives weekly text messages for 20 weeks about program goals and ways to support the index participant. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- Fluent in English
- Low adherence to cancer prevention dietary guidelines, operationalized as a score of ≤ 2 out of 4 using the National Cancer Institute method for assessing adherence to World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) lifestyle recommendations. This three-level scoring system (meeting/partially meeting/not meeting each recommendation) includes 4 items specific to diet. Participants must score equal or less than 2, meaning that they are fully meeting recommendations for no more than 2 of the 4 dietary recommendations.
- Performs the majority of the household's food shopping, and do so at stores that can passively stream item-level data from a store loyalty card to the Information Machine API (e.g., Walmart, Target, ShopRite, Wegman's, etc.)
- Has a smartphone with iOS or Android operating system that is compatible with the program app
Key exclusion criteria (4 listed)
- Medical condition or psychiatric condition (e.g., active substance abuse, eating disorder) that may limit appropriateness of or ability to comply with program dietary recommendations
- Planning to enroll in another lifestyle modification program in the next 6 months
- Bariatric surgery history
- Currently pregnant or breastfeeding or planning to become pregnant in the next 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Location-triggered notificationIf participants are randomized to have this component ON, the app will send the notification when the participant's smartphone is within a 50-meter "geofence" around designated grocery stores. No more than one notification will be sent per week. Mindfulness of program goals in the moment of decision making is expected to facilitate program-consistent food purchasing behaviors. Participants assigned to have location-triggered message delivery OFF will receive their weekly "recommendations and reminders" messages at standard times throughout the week. The content of the messages will not differ according to whether this component is ON vs. OFF. | Behavioural | LOCATION TRIGGERED MESSAGING |
| Reflections on benefits of changeParticipants will reflect on anticipated benefits of purchasing healthy foods, consistent with motivational interviewing and self-determination theory. Message content will be personalized as follows: During the initial workshop, all participants will complete an exercise identifying benefits of healthy eating that are important to them. Message content will then be programmed to be personalized according to anticipated rewards important to that participant. Participants assigned to have this intervention component OFF will not have content about anticipated benefits of change added to any messages. | Behavioural | BENEFITS OF CHANGE |
| Coach monitoringCoaches will monitor participant food purchases via a dashboard for viewing purchase data, and send messages designed to provide feedback and enhance supportive accountability for program goals. The messages will provide reinforcement for purchases consistent with program goals and express concern for areas in which adherence is low. Participants assigned to have this component OFF will not receive these extra messages or phone calls, and their food purchases will only be viewed by research staff for research outcome assessment purposes. | Behavioural | COACH MONITORING |
| Household supportIf participants are assigned to have household support ON, one adult in the household will receive weekly text messages designed to elicit support for changing food purchases. In addition, the index participant and household member will be invited to participate in one extra workshop session and three brief coaching calls focused on household support. If participants are assigned to have this OFF, household members will have no program involvement. | Behavioural | HOUSEHOLD SUPPORT |
Primary outcome
1a. Dietary Intake: ASA24 (Fiber)
Time frame: Baseline and post-treatment (0 and 20 weeks)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in grams of fiber per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
1b. Primary Outcome: Dietary Intake ASA24 (Fruit/Veg)
Time frame: Baseline and post-treatment (0 and 20 weeks)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in number of cups of fruits and vegetables per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
1c. Primary Outcome: Dietary Intake ASA24 (Red Meat)
Time frame: Baseline and post-treatment (0 and 20 weeks)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in ounces of red meat consumed per week. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
1d. Primary Outcome: Dietary Intake ASA24 (Processed Meat)
Time frame: Baseline and post-treatment (0 and 20 weeks)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in ounces of processed meat consumed per week. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
1e. Primary Outcome: Dietary Intake ASA24 (Added Sugars)
Time frame: Baseline and post-treatment (0 and 20 weeks)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in grams of added sugars consumed per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
1f. Primary Outcome: Dietary Intake ASA24 (Sodium)
Time frame: Baseline and post-treatment (0 and 20 weeks)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in mg of sodium consumed per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
1g. Primary Outcome: Dietary Intake ASA24 (Fat)
Time frame: Baseline and post-treatment (0 and 20 weeks)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in grams of saturated fat consumed per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
1h. Primary Outcome: Dietary Intake ASA24 (Sugar-Sweetened Beverages)
Time frame: Baseline and post-treatment (0 and 20 weeks)
In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24). This table reports the change in oz of sugar sweetened beverages consumed per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
2a: Dietary Intake: DHQ-III (Fiber)
Time frame: Baseline and post-treatment (0 and 20 weeks)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in grams of fiber per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
2b. Dietary Intake: DHQ-III (Fruits/Veg)
Time frame: Baseline and post-treatment (0 and 20 weeks)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in cups of fruits and vegetables per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
2c. Dietary Intake: DHQ-III (Red Meat)
Time frame: Baseline and post-treatment (0 and 20 weeks)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in oz of red meat consumed per week. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
2d. Dietary Intake: DHQ-III (Processed Meat)
Time frame: Baseline and post-treatment (0 and 20 weeks)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in oz of processed meat consumed per week. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
2e. Dietary Intake: DHQ-III (Added Sugars)
Time frame: Baseline and post-treatment (0 and 20 weeks)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in grams of added sugars consumed per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
2f. Dietary Intake: DHQ-III (Sodium)
Time frame: Baseline and post-treatment (0 and 20 weeks)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in mg of sodium consumed per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
2g. Dietary Intake: DHQ-III (Fat)
Time frame: Baseline and post-treatment (0 and 20 weeks)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in grams of saturated fat per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
2h. Dietary Intake: DHQ-III (Sugar-Sweetened Beverages)
Time frame: Baseline and post-treatment (0 and 20 weeks)
In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake. This table reports the change in ounces of sugar-sweetened beverages per day. This pilot study used a factorial design, with 16 conditions and typically 4 participants per condition. The study was designed with the intent to collapse across conditions for all analyses, such that the 8 conditions in which a given factor is ON would be compared to the 8 conditions in which that factor was OFF. Participants are counted multiple times in the table, such that the total number of participants in any ON/OFF condition pair will equal the full sample.
24 secondary outcomes
Goal Salience
Time frame: 0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Supportive Accountability
Time frame: 0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Autonomous Motivation
Time frame: 0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
External Motivation
Time frame: 0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Social Support (Encouragement)
Time frame: 0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Social Support (Discouragement)
Time frame: 0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Quality of Household Relationship
Time frame: Baseline
Weight History
Time frame: 0 weeks (Baseline)
Dietary Restraint
Time frame: 0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Uncontrolled Eating
Time frame: 0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Emotional Eating
Time frame: 0 (Baseline), 10 (Midtreatment), 20 weeks (Posttreatment)
Dietary Intake - FFQ (Guideline 1)
Time frame: 0, 10, 20 weeks
Dietary Intake - FFQ (Guideline 2)
Time frame: 0, 10, 20 weeks
Dietary Intake - FFQ (Guideline 3)
Time frame: 0, 10, 20 weeks
Dietary Intake - FFQ (Guideline 4)
Time frame: 0, 10, 20 weeks
Treatment Acceptability: 10 Weeks
Time frame: 10 weeks (mid-treatment)
Treatment Acceptability: 20 Weeks
Time frame: 20 weeks (post-treatment)
Goals and Stages of Change- Household Member
Time frame: 0 weeks
Dietary Intake-household Member
Time frame: 0, 20 weeks
Treatment Acceptability - Household
Time frame: 20 weeks
Dietary Intake- Household Member - FFQ (Guideline 1)
Time frame: 0, 20 weeks
Dietary Intake - Household Member - FFQ (Guideline 2)
Time frame: 0, 20 weeks
Dietary Intake-household Member - FFQ (Guideline 3)
Time frame: 0, 20 weeks
Dietary Intake-household Member - FFQ - Guideline 4
Time frame: 0, 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37950612Butryn ML, Hagerman CJ, Crane NT, Ehmann MM, Forman EM, Milliron BJ, Simone NL. A Proof-of-Concept Pilot Test of a Behavioral Intervention to Improve Adherence to Dietary Recommendations for Cancer Prevention. Cancer Control. 2023 Jan-Dec;30:10732748231214122. doi: 10.1177/10732748231214122.
- Derived from this study: PubMed 35749216Horgan OZ, Crane NT, Forman EM, Milliron BJ, Simone NL, Zhang F, Butryn ML. Optimizing an mHealth Intervention to Change Food Purchasing Behaviors for Cancer Prevention: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 24;11(6):e39669. doi: 10.2196/39669.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan L Butryn, PhD principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Location-triggered notification, Reflections on benefits of change and Coach monitoring in people with Cancer, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1a. Dietary Intake: ASA24 (Fiber) (time frame: Baseline and post-treatment (0 and 20 weeks)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04947150, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.