Recruiting

Observational Study

Sponsor:

University of Washington

Code:

NCT05818384

Conditions

Obesity, Adolescent

Healthy Nutrition

Sedentary Behavior

Drug Abuse

Eligibility Criteria

Sex: All

Age: 12 - 19

Healthy Volunteers: Accepted

Interventions

Wakaya: Rising Up for Choctaw Youth Curriculum

Study Details

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

Study ID

NCT05818384

Start date

Apr 28, 2023

Status verified date

Feb, 2024

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 19

Healthy Volunteers: Accepted

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

Study Design

Enrollment

176 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Wait List Control

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

experimental: Wakaya (Immediate Group)

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

Interventions

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 measure

  • 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) ]
  • Change in physical activity intensity associated with movement, measured by accelerometer [ Time Frame: Baseline and 6 months post-intervention (month 9) ]
  • 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) ]
  • 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) ]
  • Change in beverage habits over time [ Time Frame: Baseline; post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9) ]

Central Contacts and Locations

Central contacts

Tee Benally

833-265-4289tbenally@uw.edu

Locations

Choctaw Nation of Oklahoma

Recruiting

Durant, Oklahoma, United States, 74571

Contacts

Christian H Anderson

1-833-265-4289cander98@uw.edu

University of Washington, IWRI, School of Social Work

Recruiting

Seattle, Washington, United States, 98105

Contacts

Tee Benally

1-833-265-4289tbenally@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Feb 20, 2025

Last verified

Feb, 2024

Keywords

  • Native Americans
  • Youth
  • Oklahoma
  • Adolescents
  • Obesity prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Washington on 2025-02-20.