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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Wakaya Program for Childhood Obesity treatment?

The Wakaya Program for Childhood Obesity treatment may be effective as it incorporates culturally relevant strategies, similar to other successful programs like the Sandy Lake school-based intervention and the Culture-Based Talking Circle Intervention, which improved diet, self-efficacy, and cultural identity among Native American youth. ^{1 2 3 4 5}

Is the Wakaya Program for Childhood Obesity safe for children?

The available research does not provide specific safety data for the Wakaya Program for Childhood Obesity or its related names. However, similar programs focusing on nutrition education and physical activity for children have generally been considered safe, with positive health changes reported in some cases. ^{1 2 3 6 7}

What makes the Wakaya Program for Childhood Obesity treatment unique?

The Wakaya Program for Childhood Obesity is unique because it is a culturally tailored curriculum specifically designed for Choctaw youth, focusing on community involvement and cultural acceptance to promote healthy lifestyles, unlike standard treatments that may not consider cultural contexts. ^{2 3 7 8 9}

Research Team

Michelle Johnson-Jennings, PhD

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Aggressive, violent, combative or inappropriate behaviors

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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 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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Qualitative investigation of factors contributing to effective nutrition education for Navajo families. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Childhood obesity in American Indians. [2010]

4. United States pubmed.ncbi.nlm.nih.gov

Ethnic issues in the epidemiology of childhood obesity. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Culture-Based Talking Circle Intervention for Native American Youth at Risk for Obesity. [2018]

6. Australia 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Tools for Iina (Life): the journey of the Iina curriculum to the glittering world. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Development of a culturally appropriate, home-based nutrition and physical activity curriculum for Wisconsin American Indian families. [2022]

9. England 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. [2023]