Wakaya: Rising Up for Choctaw Youth Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-19
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Be enrolled in Choctaw Nation of Oklahoma (CNO)
Live within CNO tribal region for 12 months
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Wakaya: Rising Up for Choctaw Youth Curriculum
BehavioralAn 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.
Treatment groups
176 Participants
are divided into 2 treatment groupsGroup A: Wait List ControlExperimental treatment 1 intervention
Group B: Wakaya (Immediate Group)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in physical activity assessed by self-report
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.
Time frame
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
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.
Time frame
Baseline and 6 months post-intervention (month 9)3
Change in sedentary behaviors over time
Measured by the Youth Leisure-time Sedentary Behavior Questionnaire (YLSBQ) adapted for Choctaw Youth
Time frame
Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)4
Change in food and beverage habits over time
Assessed by the Youth Risk Behavior Surveillance System (YRBS) 2023.
Time frame
Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)Secondary outcomes
1
Body Mass Index (BMI) change
Mean or percentage change in BMI from baseline. Weight (kg) and height (meters) will be combined to report BMI as kg/m\^2.
Time frame
Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)2
Weight change assessed via digital scale
Mean weight change (kg)
Time frame
Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)3
Change in food addiction
The Yale Food Addiction Scale is a validated measure that has been developed to identify those who are most likely to be exhibiting markers of substance dependence with the consumption of high fat/high sugar foods. Food addiction (dichotomous) can be "diagnosed" when three symptoms and clinically significant impairment or distress are present. Continuous version of the scale ranges from 0 symptoms to 7 symptoms. Higher indicates more symptoms and worse dependence on high fat or high sugar foods.
Time frame
Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)4
Change in tobacco use frequency (non-ceremonial use) assessed by self-report
Tobacco use frequency will be assessed by 5 items on a 7-level ordinal scale from the YRBS 2023. With higher responses, reflecting greater tobacco use.
Time frame
Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov