Wakaya Program for Childhood Obesity

(Wakaya Trial)

Recruiting at 2 trial locations

Overseen By Tee Benally

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Opioid use, Methamphetamine use, Allergies, Disability, Aggressive behavior, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 25

176 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a nature-based program, built on Choctaw values, can help kids make healthier lifestyle choices. The researchers aim to determine if this program can boost physical activity, reduce screen time, encourage healthier eating, and delay or reduce alcohol, tobacco, and drug use. Participants will either start the Wakaya: Rising Up for Choctaw Youth Curriculum immediately or after a three-month wait. This program suits Choctaw youth living in the Oklahoma tribal region who often consume sugary drinks, eat fast food, or spend much time sitting or on screens. As an unphased trial, this study offers Choctaw youth a unique opportunity to engage in a culturally tailored program that could positively impact their lifestyle choices.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Wakaya program is safe for children?

Research shows that specific safety data for the Wakaya: Rising Up for Choctaw Youth Curriculum is not available. However, this program is not a drug or medical treatment. It is an educational program that helps young people develop healthier habits. Programs like this are generally safe because they encourage more physical activity and better eating habits, which most people can adopt without much risk. Since the program involves regular activities and lifestyle changes, it is likely to be well-received. Participants will engage in these activities in a supportive setting designed to encourage positive behavioral changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Wakaya: Rising Up for Choctaw Youth Curriculum because it offers a culturally tailored approach to addressing childhood obesity, unlike standard treatments that often focus purely on diet and exercise. This program integrates cultural elements and community involvement, making it more relatable and engaging for Choctaw youth. By fostering a deeper connection to their heritage and community, the program aims to promote sustainable lifestyle changes, which could lead to long-term health benefits beyond what current generic programs offer.

What evidence suggests that the Wakaya program could be effective for childhood obesity?

Research shows that the Wakaya: Rising Up for Choctaw Youth Curriculum might improve health among American Indian youth. Participants in the immediate group of this trial will start the program in the spring, using culturally relevant methods to encourage exercise and healthy eating, which have proven effective in similar programs. The program aims to boost motivation and leadership skills, helping young people make healthier lifestyle choices. Although specific data on its effectiveness is limited, the approach relies on methods that have shown promise in promoting better health habits. Participants in the wait-list control group will begin the intervention three months later, in the summer. ^{1 2 3 6 7}

Who Is on the Research Team?

Michelle Johnson-Jennings, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

The Wakaya trial is for high school students living in the Choctaw Nation of Oklahoma region who have unhealthy diets or sedentary lifestyles, and are not highly active outdoors. It's not for those with severe allergies, certain disabilities, a history of aggressive behavior, inability to follow directions, or recent opioid/methamphetamine use.

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; Engaged in excessive sitting or lying around (>540 min/day) or engage in small screen recreation (>2 hours/day); 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; Engage in any T.V., small screen/video game recreation (> 2 hours/day)

Exclusion Criteria

Aggressive, violent, combative or inappropriate behaviors

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or phone)

Baseline Assessment

Participants complete a physical health assessment and a computer-assisted behavioral health survey

1 week

1 visit (in-person)

Intervention

Participants engage in group sessions on Choctaw history, traditions, and health beliefs, including outdoor activities and motivational interviewing sessions

3 months

Up to 20 group sessions, 3 individual sessions

Follow-up

Participants are monitored for changes in physical activity, sedentary behaviors, and health habits

6 months

3 follow-up surveys

Post-intervention

Ripple Effect Mapping focus groups to assess community impact

1 month

Focus groups with selected participants

What Are the Treatments Tested in This Trial?

Interventions

• Wakaya: Rising Up for Choctaw Youth Curriculum

Trial Overview This study tests the 'Wakaya: Rising Up for Choctaw Youth Health' program which aims to boost physical activity and healthy eating while reducing drug use among youth through outdoor activities and leadership skills development based on Choctaw values.

How Is the Trial Designed?

Group I: Wakaya (Immediate Group) Experimental Treatment 1 Intervention

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

Group II: Wait List Control Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The Tools for Iina curriculum, developed by Diné educators for grades 4-6, aims to enhance children's resiliency by focusing on health, relationships, identity, and future aspirations, using core concepts from Diné oral tradition.

Instead of relying solely on expert opinions or existing curricula, the development process involved community dialogue to identify key Diné concepts, providing a culturally relevant framework for teaching young people about life challenges and relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tools for Iina (Life): the journey of the Iina curriculum to the glittering world. Arviso, V., Welle, D., Todacheene, G., et al.[2018]

A study involving 31 participants from two tribal contexts revealed that culturally relevant forms of physical activity (PA), such as family-centered activities and traditional dancing, are crucial for promoting health and preventing obesity among U.S. Indigenous peoples.

Participants emphasized the importance of nature and cultural practices in their physical activity, indicating that reconnecting with these elements can enhance mental wellness and overall health, which is vital given the historical challenges faced by Indigenous communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"We were always doing something outside. … I had a wonderful, wonderful life": U.S. Indigenous peoples' subsistence, physical activity, and the natural world. McKinley, CE.[2023]

The Healthy Children, Strong Families intervention was developed collaboratively with three Wisconsin tribes to promote healthy eating and physical activity among American Indian preschool children and their caregivers, ensuring cultural relevance.

The program's educational curriculum is based on social cognitive and family systems theories, and it has been well-received, indicating its potential for adaptation and use in other American Indian communities for obesity prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a culturally appropriate, home-based nutrition and physical activity curriculum for Wisconsin American Indian families. LaRowe, TL., Wubben, DP., Cronin, KA., et al.[2022]

A study involving 41 Navajo parents and educators identified key barriers to healthy eating for preschoolers, including cost, time pressures, and lack of nutrition knowledge.

Community feedback emphasized the importance of enhancing parental control over food choices and developing culturally relevant nutrition education strategies to support healthier eating habits among families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative investigation of factors contributing to effective nutrition education for Navajo families. Cunningham-Sabo, L., Bauer, M., Pareo, S., et al.[2021]

Childhood obesity is a widespread issue affecting various racial and ethnic groups in the U.S., with African-American and Hispanic children at a higher risk compared to white children, indicating that environmental factors rather than unique behaviors are driving this trend.

The health consequences of childhood obesity are serious, including increased risks for type 2 diabetes and adverse lipid levels, highlighting the urgent need for culturally tailored intervention strategies to effectively address obesity in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethnic issues in the epidemiology of childhood obesity. Crawford, PB., Story, M., Wang, MC., et al.[2022]

The Sandy Lake school-based diabetes prevention program significantly improved dietary knowledge, self-efficacy, and preferences among 122 Ojibway-Cree students in grades 3 to 5, as measured before and after the intervention during the 1998-1999 school year.

Higher exposure to the program was linked to increased knowledge about low-fat foods and dietary fiber intake, indicating that culturally appropriate interventions can effectively enhance healthy eating behaviors in remote First Nations communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot school-based healthy eating and physical activity intervention improves diet, food knowledge, and self-efficacy for native Canadian children. Saksvig, BI., Gittelsohn, J., Harris, SB., et al.[2023]

The community-based study showed that a cultural-based after-school intervention for Native American youth at risk for obesity was more effective than a standard health education program, improving cultural identity, perceived stress, and obesity-related knowledge and behaviors.

Participants in the cultural intervention demonstrated significant improvements in these areas immediately after the program, highlighting the importance of culturally relevant approaches in health education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Culture-Based Talking Circle Intervention for Native American Youth at Risk for Obesity. Kelley, MN., Lowe, JR.[2018]

American Indian youth face a significantly higher prevalence of obesity, with 40% to 50% classified as overweight or obese before age 10, highlighting a critical public health issue compared to historical data.

Effective obesity prevention programs must be culturally tailored and community-driven, as demonstrated by a family-directed initiative that uses telecommunications to engage local members, ensuring long-term acceptance and sustainability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Childhood obesity in American Indians. Styne, DM.[2010]

A review of eight programs aimed at preventing and managing overweight in Aboriginal and Torres Strait Islander children showed no significant weight loss, but participants experienced positive health changes like reduced waist circumference and increased exercise levels.

Future interventions should focus on community co-design and be more comprehensive, suggesting that longer, multifaceted programs led by Aboriginal communities could be more effective in addressing obesity in these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aboriginal and Torres Strait Islander children with obesity: A review of programmes for children and young people aged 5-17 years. Wallace, S., Scarcella, M., Sealy, L., et al.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/search/4LRmeLKJf0Kw-c5N5vFfUQ/project-details/10405324

Wakaya: Rising Up for Choctaw Youth Health Empirical data indicate American Indian youth are vulnerable to ill health due to adverse socio-demographic indices and little physical activity, ...

2. withpower.com withpower.com/trial/phase-healthy-nutrition-3-2023-ce75a

Wakaya Program for Childhood Obesity (Wakaya Trial) The Wakaya Program for Childhood Obesity treatment may be effective as it incorporates culturally relevant strategies, similar to other successful programs ...

3. ichgcp.net ichgcp.net/clinical-trials-registry/NCT05818384

Rising Up for Choctaw Youth Health (Wakaya) It is a multi-level intervention that increases individual motivation and leadership skills to make healthy behavioral choices for behavior and ...

4. reporter.nih.gov reporter.nih.gov/project-details/10940729

New Evidence on the Role of Federal Funding in Reducing ... Over this same period, the prevalence of obesity among children and adolescents increased by nearly 40%, and the prevalence of severe obesity increased by 70%.

5. withpower.com withpower.com/clinical-trials/for-eating-disorder

Top Eating Disorder Clinical Trials | Power 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 ...

6. reporter.nih.gov reporter.nih.gov/search/15EEC10D4C8DC5D37598B8961CAA4A01A2FFCEB861BF/project-details/11188660

Diabetes/obesity prevention in youth ... curriculum ... Wakaya: Rising Up for Choctaw Youth Health. 549 ... Preventing Childhood Obesity Through Youth Empowerment: A Cluster RCT of the H2GO! Program.

7. trialstoday.org trialstoday.org/search/results?status=recruiting&gender=&age=&zip=&radius=25&condition=&healthy=&type=&interventionalpurpose=&observationalmodel=&query=University%20of%20Iowa%20Neurology&page=eJyLViooSi3LzC8tVtJR8nMOMTAxNjMyNDdT0tG1hAEcTDM9Y2MLSwtjUx1Dc1MzMwsTCwMQ0FHKSy4xMLYwNDM2MVWKBQCSYhad

Save Selected Wakaya: Rising Up for Choctaw Youth Health. University of Washington Obesity, Adolescent Healthy Nutrition Sedentary Behavior Drug Abuse. Investigators will ...