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Obesity, AdolescentWakayaNCT05818384

Wakaya: Rising Up for Choctaw Youth Health

A study testing Wakaya: Rising Up for Choctaw Youth Curriculum in people with Obesity, Adolescent and Healthy Nutrition, run by University of Washington at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 19 yearsHealthy volunteers can take part
What is being tested?
Wakaya: Rising Up for Choctaw Youth Curriculum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
2 sitesUnited States
Study dates
28 Apr 2023to 30 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tee Benally contact

833-265-4289

tbenally@uw.edu

United States2 sites, 2 recruiting
  • Choctaw Nation of Oklahoma

    Durant, Oklahoma, 74571

    Christian H Anderson, 833-265-4289, cander98@uw.edu

    Recruiting
  • University of Washington, IWRI, School of Social Work

    Seattle, Washington, 98105

    Tee Benally, 833-265-4289, tbenally@uw.edu

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Wakaya: Rising Up for Choctaw Youth Curriculum
Keywords
Native Americans, Youth, Oklahoma, Adolescents, Obesity prevention
Medical subject headings
Pediatric Obesity, Sedentary Behavior, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wakaya: Rising Up for Choctaw Youth CurriculumBehavioural

    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.

Study groups in NCT05818384
Study groupRoleWhat they receive
Wait List ControlExperimentalParticipants in the Wait List group will be randomly assigned to start the intervention 3 months later in the Summer.
Receives: Behavioral: Wakaya: Rising Up for Choctaw Youth Curriculum
Wakaya (Immediate Group)ExperimentalParticipants in the immediate group will be randomly assigned to start the intervention immediately in the Spring.
Receives: Behavioral: Wakaya: Rising Up for Choctaw Youth Curriculum

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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

    Measured: 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.

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

  5. 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.

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

Secondary outcomes (7)
  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.

    Measured: 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)

    Measured: 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.

    Measured: 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.

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

  5. Change in alcohol use over time

    Alcohol use (current use, binge drinking) assessed by the YRBS 2023.

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

  6. Change in marijuana use over time

    Past 30 day marijuana use (smoking, vaping, edibles) assessed by the YRBS 2023.

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

  7. Change in drug and alcohol refusal self-efficacy

    The Specific Event Drug and Alcohol Refusal Self-Efficacy (SEDARE) measure captures the perceived likelihood that youth will use drugs and alcohol in specific situations on a 3-point scale (Yes, No, Unsure). The SEDARE produces two scores ranging from 0 to 8. Higher scores reflect greater self-efficacy to refuse alcohol or drugs.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start28 Apr 2023
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05818384
Sponsor's protocol ID
STUDY00015208
Other IDs
1R01DA056416
Acronym
Wakaya
Status last verified
Sep 2026
First submitted
27 Mar 2023
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Wakaya: Rising Up for Choctaw Youth Curriculum in people with Obesity, Adolescent and Healthy Nutrition, run by University of Washington at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tee Benally (833-265-4289, tbenally@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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