Clinical trial NCT05818384: Wakaya: Rising Up for Choctaw Youth Health
Official title: Wakaya: Rising Up for Choctaw Youth Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Adolescent
Healthy Nutrition
Sedentary Behavior
Drug Abuse
Keywords: Native Americans
Youth
Oklahoma
Adolescents
Obesity prevention
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-04-18
Enrollment: 176
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Detailed description: Study participants will be recruited in staggered cohorts with those in each recruitment wave receiving individual-level random assignment to either immediate intervention or waitlist control (3 months wait to intervention) for a total of 176 Choctaw youth (ages 12-19 years) participating over 5 years.

Recruitment strategies:

The following Recruitment strategies will be used: posting flyers, posters and brochures in stores, community centers, and other locations identified by our community advisors; and posting flyers in the tribal newspaper, school newsletters, tribal gathering areas, tribal health fairs, pow wows, local boys and girls clubs, youth centers, other local news outlets, and on a study webpage.

Screening:

* Participants will mainly be screened in-person, some may be screened over phone using the same talking points.
* Youth who are screened out will be given a community resource list.
* If a person is eligible, but declines to participate, they will be given a brief one-item exit question regarding general reason for non-participation.
* Eligible youth who agree to participate will be asked to schedule their baseline assessment.

After consent or assent and parental permission are obtained, CNO study staff will set up the study laptop and headphones that the participant will use to enter their responses to the baseline computer-assisted questionnaire.

Assessments:

The baseline assessment consists of a brief physical health assessment and a computer-assisted behavioral health survey administered by study staff. Youth participants are required to take a non-invasive physical health assessment (BMI with portable digital weight scale and height measure), identify the age they began puberty (girls \< 12 years old began menstruation; boys \<14 when voice changed "a lot" will be classified as early puberty) and to use an accelerometer for 7 days after the baseline assessment. They will also be asked to run or walk for 12 minutes. The computer-assisted behavioral health survey will ask a series of questions and take under 45 minutes to complete.

The assessments will be conducted via Audio-Computer Assisted Self-Interviews (ACASI) programmed into study computers. Participants will complete 4 surveys: baseline, immediately after Trail of Tears Walk, a three-month follow up,and a six-month follow-up.

Intervention Schedule:

Month 1-3: Up to 20 group sessions on Choctaw history, traditions, cultural systems and health beliefs. Experiential, outdoor activities are incorporated to promote group cohesion, improve relational worldviews, and connectedness to nature and the environment. Examples include activities on an outdoor ropes course or increasing physical activity by walking or gardening. Fitbits will be given to participants and peers can choose to support each other to meet goals on a social media platform. Up to 3 individual Motivational Interviewing sessions to identify personal change goals and community leadership.

Month 2-3: Attend an Overnight Culture Camp to strengthen group cohesion and synthesize goals.

Month 3: Walk on the Choctaw Trail of Tears and visit ancient sites. Upon completion, make a commitment to conduct a community-wide event based on personal and leadership goals and Trail experience.

Months 4-12: Up to 6 group meetings to plan community leadership events related to obesity prevention, includes an individual MI booster session to revise their personal \& community leadership goals, digital storytelling training, and a community Traditional Games Olympiad. Participants may create a story related to healthful food habits, obesity prevention and alcohol, tobacco and other drug use (ATOD).

Month 9: Share digital stories, community events, and participate in a leadership ceremony.

Post-intervention: Ripple Effect Mapping focus groups among 64 individuals. A random selection of 12 youth per region and 4 nonparticipant community stakeholders i.e., elders, leaders in the community.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
measure: Change in physical activity intensity associated with movement, measured by accelerometer
timeFrame: Baseline and 6 months post-intervention (month 9)
measure: Change in sedentary behaviors over time
timeFrame: Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
measure: Change in food and beverage habits over time
timeFrame: Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
measure: Change in beverage habits over time
timeFrame: Baseline; post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
Secondary outcomes:
measure: Body Mass Index (BMI) change
timeFrame: Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
measure: Weight change assessed via digital scale
timeFrame: Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
measure: Change in food addiction
timeFrame: Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
measure: Change in tobacco use frequency (non-ceremonial use) assessed by self-report
timeFrame: Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
measure: Change in alcohol use over time
timeFrame: Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
measure: Change in marijuana use over time
timeFrame: Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
measure: Change in drug and alcohol refusal self-efficacy
timeFrame: Baseline; Immediate post-intervention (month 3) 3 months post (month 6); 6 months post-intervention (month 9)
Other outcomes:
Locations:
city: Durant
country: United States
facility: Choctaw Nation of Oklahoma
state: Oklahoma
city: Seattle
country: United States
facility: University of Washington, IWRI, School of Social Work
state: Washington
Study officials:
affiliation: University of Washington
name: Michelle Johnson-Jennings, PhD
role: PRINCIPAL_INVESTIGATOR
References: