NCT05818384 · University of Washington
Wakaya: Rising Up for Choctaw Youth Health
(Wakaya)
What this study is about
Investigators will conduct a two-group randomly assigned waitlist-control trial to assess the effectiveness 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Wakaya: Rising Up for Choctaw Youth Curriculum
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.
Primary outcome measures
Change in physical activity assessed by self-report
Time frame: Baseline; Immediate post-intervention (month 3); 3 months post (month 6); and 6 months post-intervention (month 9)
Assessed by the International Physical Activity Questionnaire-Short Form (IPAQ) for youth and young adults. Results can be reported in categories (low, moderate or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.
Change in physical activity intensity associated with movement, measured by accelerometer
Time frame: Baseline and 6 months post-intervention (month 9)
An actigraph accelerometer measures vertical acceleration in counts per minute. It will be worn for 7 days. Mean counts per minute are calculated by dividing the sum of activity counts for a valid day be the number of minutes of wear time in a day for all valid days. Greater number of counts per minute indicates higher physical activity intensity. Change in mean counts per minute from baseline at 9 months will be assessed.
Change in sedentary behaviors over time
Time frame: Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
Measured by the Youth Leisure-time Sedentary Behavior Questionnaire (YLSBQ) adapted for Choctaw Youth
Change in food and beverage habits over time
Time frame: Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
Assessed by the Youth Risk Behavior Surveillance System (YRBS) 2023.
Change in beverage habits over time
Time frame: Baseline; post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
Assessed by the Modified Healthy Home Survey (2005- Beverages). It assesses the number of sweetened drinks consumed per week.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Durant, Oklahoma
- Seattle, Washington
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 20, 2025 · Source of record for eligibility and locations