Make Better Choices 2 for Rural Appalachians (NCT04309461) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Make Better Choices 2 for Rural Appalachians
United States279 participantsStarted 2020-08-01
Plain-language summary
The program consists of four interconnected components: (1) app, (2) accelerometer, (3) health coaching, and (4) behavioral incentives to increase food and vegetable intake, reduce saturated fat intake, increase physical activity, and decrease sedentary screen time among adults Appalachia Kentuckians.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* adults residing in Appalachian Kentucky
* willingness to use smart phone to record and modify diet and activity
* willingness to wear an accelerometer
* consume \<4.5 cups fruit/vegetables daily
* consume \>8% daily calories from fat
* engage in \<150 minutes of moderate-intensity physical activity weekly
* spend \>90 minutes daily on non-work, non-education-related sedentary recreational use of screen time.
Exclusion Criteria:
* unstable medical conditions
* cognitive impairment
* hospitalization for psychiatric disorder within the last 5 years
* active suicidal ideation
* substance use disorder other than nicotine dependence
* at risk for adverse cardiovascular events with moderate-intensity activity
* taking weight loss medication
* trying to get pregnant, pregnant or lactating
* active eating disorders
* using mobility assistive devices
* inability to read study materials
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in diet and activity
Timeframe: 9 months (at baseline, 3 months and 9 months)