Wakaya: Rising Up for Choctaw Youth Health (NCT05818384) | Clinical Trial Compass
RecruitingNot Applicable
Wakaya: Rising Up for Choctaw Youth Health
United States176 participantsStarted 2023-04-28
Plain-language summary
Investigators will conduct a two-group randomized waitlist-control trial to assess the efficacy of the Wakaya: Rising Up for Choctaw Youth Health program on improving physical activity, reducing sedentary behaviors and improving healthful eating habits as well as delaying or reducing alcohol, tobacco and other drug use. Wakaya is an experiential, outdoor, nature-based program grounded in Choctaw values. It is a multi-level intervention that increases individual motivation and leadership skills to make healthy behavioral choices for behavior and exercise.
Who can participate
Age range
12 Years – 19 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:
* Be enrolled in Choctaw Nation of Oklahoma (CNO)
* Live within CNO tribal region for 12 months
YES to one of the following:
* Consumed sweetened beverages or processed/fast food 2x or more per week; OR
* Engaged in excessive sitting or lying around (\>540 min/day) or engage in small screen recreation (\>2 hours/day); OR
* Physical activity - spend \<60 minutes/day outdoors or \<2.5 hrs per week in moderate or vigorous physical activity OR spend \<60 minutes a day in moderate or vigorous intensity aerobic activity; OR
* Engage in any T.V., small screen/video game recreation (\> 2 hours/day)
Exclusion Criteria:
* opioid/methamphetamine drug use (2 times or more in past month)
* allergic reactions to food (e.g. peanuts), plant (poison oak or ivy) or insects (e.g. bees, fire ants) that caused difficulty in breathing or necessitated hospitalization or caused an anaphylactic reaction
* disability that prevents student from walking or from engaging in exercise
* aggressive, violent, combative or inappropriate behaviors
* inability to follow directions
* psychotic symptoms
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 physical activity assessed by self-report
Timeframe: Baseline; Immediate post-intervention (month 3); 3 months post (month 6); and 6 months post-intervention (month 9)
2
Change in physical activity intensity associated with movement, measured by accelerometer
Timeframe: Baseline and 6 months post-intervention (month 9)