Diet QualityADOPTNCT05049005
Alternative Dietary Approaches Online to Promote Tracking
A study testing Simplified dietary tracking in people with Diet Quality and Weight Loss, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: Compare the efficacy of two 3-month Internet-based interventions that use a simplified strategy for monitoring of dietary intake among young adult men and women with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Quality, Weight Loss
- What is being tested?
- Simplified dietary tracking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to 4 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) between 25 and 50 kg/m^2
- English-speaking and writing
- Own a smartphone with an active data and text messaging plan
- Own a bathroom scale or willing to purchase a bathroom scale prior to the study start date
- Willing to be randomized to either group
Who cannot join
- Type I or Type 2 diabetes
- Currently participating in another nutrition or weight loss program
- Lost 10 or more pounds (and kept it off) in the last 6 months
- Currently taking weight loss medications
- Currently pregnant, pregnant within the past 6 months, or planning to become pregnant in the next 6 months
- Serious current physical disease (i.e. heart disease, stroke, cancer, or renal disease) for which physician supervision of diet and exercise prescription is needed
Show all 12Show fewer
- Physical problems that limit the ability to exercise daily
- History of clinically diagnosed eating disorder
- Report a past diagnosis of or current symptoms of alcohol or substance dependence
- Diagnosis of schizophrenia or bipolar disorder
- Hospitalization for a psychiatric diagnosis within the last year
- Currently living with another study participant
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Weight Research Program
Chapel Hill, North Carolina, 27514
About this study
Official title: Dietary Approaches for Improving Engagement, Diet Quality, and Weight Loss in Young Adults
Purpose: Compare the efficacy of two 3-month Internet-based interventions that use a simplified strategy for monitoring of dietary intake among young adult men and women with overweight or obesity.
Participants: Young adult men and women who are between the ages of 18-35 years (N=75) and who currently have overweight or obesity (BMI between 25 and 50 kg/m^2).
Procedures (methods): This is a randomized controlled trial comparing the efficacy of two Internet-based dietary interventions among 75 young adult men and women who currently have overweight or obesity. Both interventions will use simplified monitoring of dietary intake using an approach based on the Traffic Light Diet. One intervention will target a reduction in intake of red foods (high-calorie, high-fat foods) and tracking of red foods in the study website. The other intervention will target an increase in intake of green foods (low-calorie, healthy foods) and tracking of green foods in the study website. Components of both interventions include (1) personalized goals for red/green food intake, (2) weekly tailored feedback, and (3) weekly lessons delivered via smartphone.
Read the detailed description
The primary objective of the study is to test two approaches for dietary self-monitoring among young adults with overweight/obesity. Thus, all participants will receive an Internet-based dietary intervention that includes evidence-based lessons focused on dietary change, behavioral skills training, and frequent weighing. The only difference between the two groups will be the types of foods participants are instructed to self-monitor and the dietary goals participants are given. Young adult men and women (N=75) will be randomly assigned, with equal probability, to one of two groups:
- Red food reduction intervention (RED FOOD): An Internet-based dietary intervention delivered via REDCap; weekly self-report of weight and daily red food monitoring using a mobile-optimized study website.
- Green food promotion intervention (GREEN FOOD): An Internet-based dietary intervention delivered via REDCap; weekly self-report of weight and daily green food monitoring using a mobile-optimized study website.
During the 3-month Internet-based dietary intervention, participants will receive an email at the beginning of each week with a link to a REDCap page that will ask them to self-report their weight. They will then be directed via REDCap to their tailored feedback summaries based on their self-reported weight data and the dietary monitoring data that is pulled from the study website. After reading their feedback, participants will be directed to a weekly lesson in REDCap. Participants will be encouraged to login to the study website every day to self-monitor red or green foods, depending on their intervention group. Participants will receive a unique username and password to login to the study website. Each intervention component is described in more detail below.
Intervention Components:
Participant goals: Participants will be assigned a dietary goal based on their baseline weight. Participants will be able to view their daily dietary goal (number of red foods per day in RED FOOD and number of green foods per day in GREEN FOOD) on the study website. Participants' dietary goals will be based on their intervention group. Participants will not receive specific goals for weighing or physical activity. However, all participants will be recommended to weigh frequently throughout the week, as research has shown this is best for successful weight loss. Participants will self-report their weight online via REDCap once per week.
Weekly feedback: Participants will receive tailored feedback summaries via REDCap weekly. Participants will receive an email to self-report their weight in REDCap, after which they will be directed to their feedback page. The feedback message will include feedback based on participants' number of days tracking diet, progress toward their dietary goal, and self-reported weight for the week.
Lessons: Lessons will be updated weekly and made available in REDCap. Lesson content will focus on specific areas of diet or eating behavior which participants could focus on changing over the next week. Behavioral topics typically included in behavioral weight control programs will be incorporated into the lessons including problem solving, planning ahead, and stimulus control. Participants will be directed to the REDCap lesson after reviewing their weekly feedback message.
- Conditions
- Diet Quality, Weight Loss
- Being tested
- Simplified dietary tracking
- Keywords
- Adherence, diet tracking, diet goals
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplified dietary trackingBehavioural
Mobile-delivered nutrition program using simplified dietary monitoring with a focus on weight loss.
| Study group | Role | What they receive |
|---|---|---|
| RED FOOD Intervention Group | Active comparator | Participants in the RED FOOD group will be taught a simplified way of identifying high-calorie foods (red foods) and reducing them using the Traffic Light Diet. Limiting the number of red foods consumed is a simple way to reduce calories without having to track calories. Participants in this group will use the study website to track their red foods and will be given a daily red food limit base on their baseline weight and will track their red foods on the study website daily. Participants will be recommended to enter their red foods at least once per day (at which time they would enter all red foods for the day), but ideally multiple times per day to reduce errors associated with recall. Receives: Behavioral: Simplified dietary tracking |
| GREEN FOOD Intervention Group | Experimental | Participants in the GREEN FOOD group will be taught a simplified way of identifying low-calorie foods (green foods) and maximizing them using the Traffic Light Diet. Maximizing the number of green foods consumed is a simple way to reduce dietary energy density while allowing for consumption of a satisfying amount (i.e. weight and volume) of food. Maximizing green food consumption may simultaneously reduce red food consumption, thereby reducing calorie intake and promoting greater diet quality than red food reduction alone. Participants in this group will also use the study website to track their green foods and will be given a daily green food goal based on their baseline weight and will track their green foods on the study website daily. Participants will be recommended to enter their green foods at least once per day (at which time they would enter all green foods for the day), but ideally multiple times per day to reduce errors associated with recall. Receives: Behavioral: Simplified dietary tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to dietary tracking
Adherence will be assessed via frequency of dietary monitoring. Each food entry will be time-stamped and automatically captured by the study website interface. Frequency of dietary monitoring will be defined as the total number of days during the 3-month intervention that participants tracked breakfast or lunch AND dinner, which will be considered a full (versus partial) day of tracking.
Measured: 3 months
Adherence to dietary goals
Adherence will be measured as the total number of full days of tracking (i.e. breakfast or lunch AND dinner) during which participants met their dietary goal. Non-adherence will be assumed for partial days of tracking, or days where participants did not track.
Measured: 3 months
Secondary outcomes (3)
Percent weight loss
Percent weight loss (PWL) from baseline to 3 months will be calculated using the following formula, which results in increasingly negative values as weight declines: ((weight at 3 months - baseline weight)/baseline weight)*100
Measured: 3 months
Change in Dietary intake
Assessed using using the Automated Self-Administered 24-Hour Recall (ASA24). This online system guides participants through a multi-pass recall of foods eaten over the previous 24 hours. Intake will be measured twice (one weekday and one weekend day) at each time point to provide the most accurate representation of typical consumption. The system creates researcher reports of intake that include total energy intake, macronutrients, and micronutrients.
Measured: Baseline, Month 3
Change in Diet quality
The Healthy Eating Index (HEI)-2015 will be used to assess diet quality based on the major dietary recommendations of the 2015 Dietary Guidelines for Americans (DGA). The HEI-2015 consists of 13 component scores, including: total fruit, whole fruit, total protein foods, total vegetables, greens and beans, whole grains, dairy, seafood and plant proteins, fatty acids, sodium, refined grains, added sugars, and saturated fats. The summation of the 13 component scores ranges from 0 to 100, with higher scores indicating closer compliance with the 2015 DGA.
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start4 Oct 2021
- Primary completion4 Jul 2022
- Study completion4 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet QualityStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julianne M Power, MS, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049005
- Sponsor's protocol ID
- 20-0491
- Acronym
- ADOPT
- Status last verified
- Mar 2022
- First submitted
- 9 Sep 2021
- Last updated
- 12 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Approaches for Improving Engagement, Diet Quality, and Weight Loss in Young Adults
- ClinicalTrials.gov ID
- NCT05049005
- Acronym / sponsor ID
- ADOPT / 20-0491
- Conditions
- Diet Quality, Weight Loss
- Keywords
- Adherence, diet tracking, diet goals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 4 Jul 2022 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: Compare the efficacy of two 3-month Internet-based interventions that use a simplified strategy for monitoring of dietary intake among young adult men and women with overweight or obesity.
Participants: Young adult men and women who are between the ages of 18-35 years (N=75) and who currently have overweight or obesity (BMI between 25 and 50 kg/m^2).
Procedures (methods): This is a randomized controlled trial comparing the efficacy of two Internet-based dietary interventions among 75 young adult men and women who currently have overweight or obesity. Both interventions will use simplified monitoring of dietary intake using an approach based on the Traffic Light Diet. One intervention will target a reduction in intake of red foods (high-calorie, high-fat foods) and tracking of red foods in the study website. The other intervention will target an increase in intake of green foods (low-calorie, healthy foods) and tracking of green foods in the study website. Components of both interventions include (1) personalized goals for red/green food intake, (2) weekly tailored feedback, and (3) weekly lessons delivered via smartphone.
Detailed description
The primary objective of the study is to test two approaches for dietary self-monitoring among young adults with overweight/obesity. Thus, all participants will receive an Internet-based dietary intervention that includes evidence-based lessons focused on dietary change, behavioral skills training, and frequent weighing. The only difference between the two groups will be the types of foods participants are instructed to self-monitor and the dietary goals participants are given. Young adult men and women (N=75) will be randomly assigned, with equal probability, to one of two groups:
- Red food reduction intervention (RED FOOD): An Internet-based dietary intervention delivered via REDCap; weekly self-report of weight and daily red food monitoring using a mobile-optimized study website.
- Green food promotion intervention (GREEN FOOD): An Internet-based dietary intervention delivered via REDCap; weekly self-report of weight and daily green food monitoring using a mobile-optimized study website.
During the 3-month Internet-based dietary intervention, participants will receive an email at the beginning of each week with a link to a REDCap page that will ask them to self-report their weight. They will then be directed via REDCap to their tailored feedback summaries based on their self-reported weight data and the dietary monitoring data that is pulled from the study website. After reading their feedback, participants will be directed to a weekly lesson in REDCap. Participants will be encouraged to login to the study website every day to self-monitor red or green foods, depending on their intervention group. Participants will receive a unique username and password to login to the study website. Each intervention component is described in more detail below.
Intervention Components:
Participant goals: Participants will be assigned a dietary goal based on their baseline weight. Participants will be able to view their daily dietary goal (number of red foods per day in RED FOOD and number of green foods per day in GREEN FOOD) on the study website. Participants' dietary goals will be based on their intervention group. Participants will not receive specific goals for weighing or physical activity. However, all participants will be recommended to weigh frequently throughout the week, as research has shown this is best for successful weight loss. Participants will self-report their weight online via REDCap once per week.
Weekly feedback: Participants will receive tailored feedback summaries via REDCap weekly. Participants will receive an email to self-report their weight in REDCap, after which they will be directed to their feedback page. The feedback message will include feedback based on participants' number of days tracking diet, progress toward their dietary goal, and self-reported weight for the week.
Lessons: Lessons will be updated weekly and made available in REDCap. Lesson content will focus on specific areas of diet or eating behavior which participants could focus on changing over the next week. Behavioral topics typically included in behavioral weight control programs will be incorporated into the lessons including problem solving, planning ahead, and stimulus control. Participants will be directed to the REDCap lesson after reviewing their weekly feedback message.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RED FOOD Intervention Group | Active comparator | Behavioral: Simplified dietary trackingParticipants in the RED FOOD group will be taught a simplified way of identifying high-calorie foods (red foods) and reducing them using the Traffic Light Diet. Limiting the number of red foods consumed is a simple way to reduce calories without having to track calories. Participants in this group will use the study website to track their red foods and will be given a daily red food limit base on their baseline weight and will track their red foods on the study website daily. Participants will be recommended to enter their red foods at least once per day (at which time they would enter all red foods for the day), but ideally multiple times per day to reduce errors associated with recall. |
| GREEN FOOD Intervention Group | Experimental | Behavioral: Simplified dietary trackingParticipants in the GREEN FOOD group will be taught a simplified way of identifying low-calorie foods (green foods) and maximizing them using the Traffic Light Diet. Maximizing the number of green foods consumed is a simple way to reduce dietary energy density while allowing for consumption of a satisfying amount (i.e. weight and volume) of food. Maximizing green food consumption may simultaneously reduce red food consumption, thereby reducing calorie intake and promoting greater diet quality than red food reduction alone. Participants in this group will also use the study website to track their green foods and will be given a daily green food goal based on their baseline weight and will track their green foods on the study website daily. Participants will be recommended to enter their green foods at least once per day (at which time they would enter all green foods for the day), but ideally multiple times per day to reduce errors associated with recall. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body Mass Index (BMI) between 25 and 50 kg/m^2
- English-speaking and writing
- Own a smartphone with an active data and text messaging plan
- Own a bathroom scale or willing to purchase a bathroom scale prior to the study start date
- Willing to be randomized to either group
Key exclusion criteria (12 listed)
- Type I or Type 2 diabetes
- Currently participating in another nutrition or weight loss program
- Lost 10 or more pounds (and kept it off) in the last 6 months
- Currently taking weight loss medications
- Currently pregnant, pregnant within the past 6 months, 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 |
|---|---|---|
| Simplified dietary trackingMobile-delivered nutrition program using simplified dietary monitoring with a focus on weight loss. | Behavioural | GREEN FOOD Intervention Group, RED FOOD Intervention Group |
Primary outcome
Adherence to dietary tracking
Time frame: 3 months
Adherence will be assessed via frequency of dietary monitoring. Each food entry will be time-stamped and automatically captured by the study website interface. Frequency of dietary monitoring will be defined as the total number of days during the 3-month intervention that participants tracked breakfast or lunch AND dinner, which will be considered a full (versus partial) day of tracking.
Adherence to dietary goals
Time frame: 3 months
Adherence will be measured as the total number of full days of tracking (i.e. breakfast or lunch AND dinner) during which participants met their dietary goal. Non-adherence will be assumed for partial days of tracking, or days where participants did not track.
3 secondary outcomes
Percent weight loss
Time frame: 3 months
Change in Dietary intake
Time frame: Baseline, Month 3
Change in Diet quality
Time frame: Baseline, Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- 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.
Julianne M Power, MS principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simplified dietary tracking in people with Diet Quality and Weight Loss, run by University of North Carolina, Chapel Hill 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 5 inclusion and 12 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 12 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence to dietary tracking (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2022.