NutritioneWellnessNCT04188002
A Web-based Tailored Health Behavior Intervention for Breast and Colon Cancer Survivors (eWellness)
A study testing Intervention Physical Activity in people with Nutrition and Physical Activity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The primary objective of this study is to compare the differences in fruits and vegetable intake and physical activity from pre- to post- study between the intervention and control groups (i.e. the difference in differences). The study involves the use of web-based educational materials over a four week period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutrition, Physical Activity
- What is being tested?
- Intervention Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2017to 1 Aug 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- primary language is English
- histologically confirmed stage 1-111A invasive breast cancer or stage 1-3 colorectal cancer
- between at least 6 months to 5 years since completion of all primary cancer treatments (e.g. surgery, radiation, chemotherapy with the exception of women on adjuvant Herceptin therapy)
- have access to the internet; have an email and/or cell phone (to accept text message reminders from the study).
Who cannot join
- Include women that may be pregnant and anyone that is/has:
- A history of another cancer (exception for non-melanoma skin cancers)
- Self-reported comorbidities that would preclude engaging in physical activity safely (e.g. functional limitations or symptomatic cardiovascular or pulmonary disease)
- Plans or scheduled for major surgery (including breast reconstruction) during the intervention time frame
- Any psychiatric illness that would make it difficult to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
The primary objective of this study is to compare the differences in fruits and vegetable intake and physical activity from pre- to post- study between the intervention and control groups (i.e. the difference in differences). The study involves the use of web-based educational materials over a four week period. The investigators hypothesize that those in the intervention group will show a greater increase in fruit and vegetable intake and engage in more physical activity than those randomized to the control group. Eligible breast and colorectal cancer survivors from the UNC Health Registry/Cancer Survivorship Cohort (UNC HR/CSC) will be selected, consented, and randomized to either the intervention or control group. Both groups will fill out baseline surveys. The intervention group will receive a total to 4 newsletters for 4 weeks and at the beginning of week 5, they will asked to complete the follow-up survey online. The intervention newsletters focus on increasing physical activity and healthy diets. The control group will receive 4 newsletters in the same time frame as the intervention. The focus of the control group's newsletters will be on topics relevant to cancer survivors (e.g. getting back to work after treatment, managing finances) but will not focus on physical activity or diet. All contact with participants will take place online (i.e. surveys and newsletter delivery) from the study web site.
Read the detailed description
This study is adapted from the WATCH (Wellness for African Americans Through Churches) Project. WATCH was a randomized trial among 587 African American members of 12 rural North Carolina churches that demonstrated the effectiveness of a mailed tailored print and video intervention consisting of four individually tailored newsletters and targeted videos to improve diet and physical activity behaviors: there were significant improvements in fruit and vegetable consumption (0.6 servings) and recreational physical activity (2.5 MET-hours per week), and a non-significant decrease in fat intake in the intervention churches. The overall goal of this application is to conduct a study (called "eWellness") to investigate whether the WATCH tailored print messages and videos can be effectively and efficiently disseminated to a different population (breast and colon cancer survivors) and using a different delivery channel (electronic technology via the internet and world wide web.
- Conditions
- Nutrition, Physical Activity
- Being tested
- Intervention Physical Activity, Usual Care
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Physical ActivityBehavioural
4 tailored newsletters focused on improving healthy diet and physical activity delivered at weekly intervals.
Usual CareOther
4 non-tailored newsletters focused on issues relevant to cancer survivors (e.g. returning to work)
| Study group | Role | What they receive |
|---|---|---|
| Control - Fruit and Vegetable | Other | Participants in this arm will receive usual care. Receives: Other: Usual Care |
| Physical Activity Intervention | Other | Participants in this arm will be encouraged via tailored newsletters and email/or text reminders to improve diet and physical activities. Receives: Behavioral: Intervention Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Fruit and Vegetable Score
Fruit and vegetable consumption will be adapted from a 35-item measure used in a trial for US Blacks adapted from a 35-item measure for US Southern blacks that measures frequency of intake during the previous month. Score measures can range from 2-24. Positive or better outcomes are reflected by higher mean fruit and vegetable scores.
Measured: Month 6
Summary Fruit and Vegetable Score
The frequency of fruit and vegetable intake will be measured during the previous month, using a 2-item measure (How many servings of fruits do you eat each day?) and a similar question for vegetables that assesses usual vegetable intake. Scores can range from 0-N with higher scores indicating more fruit and/or vegetable intake.
Measured: Month 6
Metabolic Equivalent Task Hours (METs) for Physical Activity
Moderate to physical activity will be assessed and frequency of different types of activity, with response options of: don't do, 1-3 times/month, 1-2 times/week, 3-4 times/week, or 5 or more times/week. Items include various types of activities gathered from an 11-item instrument modified for cultural appropriateness from a previous study. For each activity, participants estimate duration as either <20 minutes or 20 or more minutes per session. Physical activity is then calculated in terms of metabolic equivalent task hours (METs) per week. MET values for energy expenditure were assigned to each activity based on validated instruments.21 MET-hours are computed by multiplying frequency times duration (converted to hours/week) times the MET value. Reported physical activity time can range from 0 minutes - 6 hours or more for reported sedentary behaviors. Higher reported values equate to better reported outcomes of increased physical activity for participants.
Measured: Month 6
Secondary outcomes (5)
Recruitment rate
Recruitment rate is defined as the number of screened participants that meet eligibility criteria divided by the number of individuals screened.
Measured: Month 6
Percentage of Participants Completing the Intervention and Follow-Up Assessments
Retention
Measured: Month 6
Number of Newsletters Read/Downloaded
Participant Adherence
Measured: Month 6
Program Process Evaluation
This will be assessed with process evaluation questions at follow-up survey and metrics of website use (e.g. number of times visiting site). Questions will ask about participants' perceptions and experiences with the intervention and may provide valuable information about how to modify the programs for future use in this population. Measures will be adapted from those used in our previous studies and assess ease of use, intervention instructions and length, attractiveness, perceived personal relevance, recall, credibility, novelty, and usefulness for making healthy changes, and satisfaction with intervention components. Higher values will represent better outcomes for program process evaluation.
Measured: 6 months
Number of Times Visiting the Site
An evaluation of website metrics will be conducted to assess program acceptability.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start25 Mar 2017
- Primary completion31 Jul 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NutritionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single institution, randomized clinical trial designed to evaluate a four week web-based tailored health behavior intervention in breast and colon cancer survivors.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas
- Responsible party
- Sponsor
- Investigators
- Carmina Valle, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188002
- Sponsor's protocol ID
- 16-1897
- Acronym
- eWellness
- Status last verified
- Nov 2019
- First submitted
- 3 Dec 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Resnicow K, Morabia A. The relation between body mass index and plasma total cholesterol in a multiracial sample of US schoolchildren. Am J Epidemiol. 1990 Dec;132(6):1083-90. doi: 10.1093/oxfordjournals.aje.a115751.
PubMed 2260540
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Web-based Tailored Health Behavior Intervention for Breast and Colon Cancer Survivors (eWellness)
- ClinicalTrials.gov ID
- NCT04188002
- Acronym / sponsor ID
- eWellness / 16-1897
- Conditions
- Nutrition, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- University of Texas
- Study start
- 25 Mar 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 5 Dec 2019 (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.
The primary objective of this study is to compare the differences in fruits and vegetable intake and physical activity from pre- to post- study between the intervention and control groups (i.e. the difference in differences). The study involves the use of web-based educational materials over a four week period. The investigators hypothesize that those in the intervention group will show a greater increase in fruit and vegetable intake and engage in more physical activity than those randomized to the control group. Eligible breast and colorectal cancer survivors from the UNC Health Registry/Cancer Survivorship Cohort (UNC HR/CSC) will be selected, consented, and randomized to either the intervention or control group. Both groups will fill out baseline surveys. The intervention group will receive a total to 4 newsletters for 4 weeks and at the beginning of week 5, they will asked to complete the follow-up survey online. The intervention newsletters focus on increasing physical activity and healthy diets. The control group will receive 4 newsletters in the same time frame as the intervention. The focus of the control group's newsletters will be on topics relevant to cancer survivors (e.g. getting back to work after treatment, managing finances) but will not focus on physical activity or diet. All contact with participants will take place online (i.e. surveys and newsletter delivery) from the study web site.
Detailed description
This study is adapted from the WATCH (Wellness for African Americans Through Churches) Project. WATCH was a randomized trial among 587 African American members of 12 rural North Carolina churches that demonstrated the effectiveness of a mailed tailored print and video intervention consisting of four individually tailored newsletters and targeted videos to improve diet and physical activity behaviors: there were significant improvements in fruit and vegetable consumption (0.6 servings) and recreational physical activity (2.5 MET-hours per week), and a non-significant decrease in fat intake in the intervention churches. The overall goal of this application is to conduct a study (called "eWellness") to investigate whether the WATCH tailored print messages and videos can be effectively and efficiently disseminated to a different population (breast and colon cancer survivors) and using a different delivery channel (electronic technology via the internet and world wide web.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a single institution, randomized clinical trial designed to evaluate a four week web-based tailored health behavior intervention in breast and colon cancer survivors.
| Arm | Type | Receives |
|---|---|---|
| Control - Fruit and Vegetable | Other | Other: Usual CareParticipants in this arm will receive usual care. |
| Physical Activity Intervention | Other | Behavioral: Intervention Physical ActivityParticipants in this arm will be encouraged via tailored newsletters and email/or text reminders to improve diet and physical activities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age
- primary language is English
- histologically confirmed stage 1-111A invasive breast cancer or stage 1-3 colorectal cancer
- between at least 6 months to 5 years since completion of all primary cancer treatments (e.g. surgery, radiation, chemotherapy with the exception of women on adjuvant Herceptin therapy)
- have access to the internet; have an email and/or cell phone (to accept text message reminders from the study).
Key exclusion criteria (5 listed)
- A history of another cancer (exception for non-melanoma skin cancers)
- Self-reported comorbidities that would preclude engaging in physical activity safely (e.g. functional limitations or symptomatic cardiovascular or pulmonary disease)
- Plans or scheduled for major surgery (including breast reconstruction) during the intervention time frame
- Any psychiatric illness that would make it difficult to participate in the study
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 |
|---|---|---|
| Intervention Physical Activity4 tailored newsletters focused on improving healthy diet and physical activity delivered at weekly intervals. | Behavioural | Physical Activity Intervention |
| Usual Care4 non-tailored newsletters focused on issues relevant to cancer survivors (e.g. returning to work) | Other | Control - Fruit and Vegetable |
Primary outcome
Mean Fruit and Vegetable Score
Time frame: Month 6
Fruit and vegetable consumption will be adapted from a 35-item measure used in a trial for US Blacks adapted from a 35-item measure for US Southern blacks that measures frequency of intake during the previous month. Score measures can range from 2-24. Positive or better outcomes are reflected by higher mean fruit and vegetable scores.
Summary Fruit and Vegetable Score
Time frame: Month 6
The frequency of fruit and vegetable intake will be measured during the previous month, using a 2-item measure (How many servings of fruits do you eat each day?) and a similar question for vegetables that assesses usual vegetable intake. Scores can range from 0-N with higher scores indicating more fruit and/or vegetable intake.
Metabolic Equivalent Task Hours (METs) for Physical Activity
Time frame: Month 6
Moderate to physical activity will be assessed and frequency of different types of activity, with response options of: don't do, 1-3 times/month, 1-2 times/week, 3-4 times/week, or 5 or more times/week. Items include various types of activities gathered from an 11-item instrument modified for cultural appropriateness from a previous study. For each activity, participants estimate duration as either <20 minutes or 20 or more minutes per session. Physical activity is then calculated in terms of metabolic equivalent task hours (METs) per week. MET values for energy expenditure were assigned to each activity based on validated instruments.21 MET-hours are computed by multiplying frequency times duration (converted to hours/week) times the MET value. Reported physical activity time can range from 0 minutes - 6 hours or more for reported sedentary behaviors. Higher reported values equate to better reported outcomes of increased physical activity for participants.
5 secondary outcomes
Recruitment rate
Time frame: Month 6
Percentage of Participants Completing the Intervention and Follow-Up Assessments
Time frame: Month 6
Number of Newsletters Read/Downloaded
Time frame: Month 6
Program Process Evaluation
Time frame: 6 months
Number of Times Visiting the Site
Time frame: 6 months
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 5 Dec 2019.
- Background: PubMed 2260540Resnicow K, Morabia A. The relation between body mass index and plasma total cholesterol in a multiracial sample of US schoolchildren. Am J Epidemiol. 1990 Dec;132(6):1083-90. doi: 10.1093/oxfordjournals.aje.a115751.
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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.
Carmina Valle, PhD 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 Intervention Physical Activity in people with Nutrition and Physical Activity, 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 5 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 5 Dec 2019. 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?
Mean Fruit and Vegetable Score (time frame: Month 6). The study lists 3 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 NCT04188002, which also lists 1 linked publication.
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 5 Dec 2019.