Wakaya: Rising Up for Choctaw Youth Health

NCT05818384 | Recruiting DMC

• 2 other identifiers: STUDY000152081R01DA056416
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Obesity, Adolescent; Healthy Nutrition; Sedentary Behavior; Drug Abuse

Keywords

Native Americans; Youth; Oklahoma; Adolescents; Obesity prevention

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline; Immediate post-intervention (month 3); 3 months post (month 6); and 6 months post-intervention (month 9)

• 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.

  Baseline and 6 months post-intervention (month 9)

• Change in sedentary behaviors over time

  Measured by the Youth Leisure-time Sedentary Behavior Questionnaire (YLSBQ) adapted for Choctaw Youth

  Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)

• Change in food and beverage habits over time

  Assessed by the Youth Risk Behavior Surveillance System (YRBS) 2023.

  Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)

• Change in beverage habits over time

  Assessed by the Modified Healthy Home Survey (2005- Beverages). It assesses the number of sweetened drinks consumed per week.

  Baseline; post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)

Secondary Outcomes (7)

• Body Mass Index (BMI) change

  Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)

• Weight change assessed via digital scale

  Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)

• Change in food addiction

  Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)

• Change in tobacco use frequency (non-ceremonial use) assessed by self-report

  Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)

• Change in alcohol use over time

  Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)

Study Arms (2)

Wait List Control

EXPERIMENTAL

Participants in the Wait List group will be randomly assigned to start the intervention 3 months later in the Summer.

Behavioral: Wakaya: Rising Up for Choctaw Youth Curriculum

Wakaya (Immediate Group)

EXPERIMENTAL

Participants in the immediate group will be randomly assigned to start the intervention immediately in the Spring.

Behavioral: Wakaya: Rising Up for Choctaw Youth Curriculum

Interventions

Wakaya: Rising Up for Choctaw Youth Curriculum BEHAVIORAL

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.

Wait List Control; Wakaya (Immediate Group)

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Choctaw Nation of Oklahoma

Durant, Oklahoma, 74571, United States

RECRUITING

University of Washington, IWRI, School of Social Work

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity; Sedentary Behavior; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michelle Johnson-Jennings, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tee Benally

CONTACT

833-265-4289; tbenally@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Social Work

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 18, 2023
• Study Start: April 28, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 20, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)