More Outside Your Door: a Diet/physical Activity Intervention to Decrease Risk of Obesity in Alaska Native Preschoolers

NCT ID: NCT06303544

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2028-05-30

Brief Summary

The preschool age is a crucial period of growth and an optimal time to begin to establish healthy eating and physical activity habits leading to better food and activity choices into adulthood, thereby minimizing risk for obesity-related diseases and decreasing the cardiometabolic disparities in this Indigenous population. More Outside Your Door is a multi-level, randomized, stepped-wedge intervention trial designed to reduce the disparity of childhood obesity in Yup'ik Alaska Native children by increasing the proportion of nutrient-dense traditional and traditional-like foods offered and increasing physical activity, particularly outdoor activities related to traditional Yup'ik subsistence and lifestyle practices. This 5-year intervention trial targeting 3-5 year olds is conducted in partnership with Rural Action Community Action Program Head Start programs in 12 rural Alaskan communities, where each site is assigned annually to a wedge group to receive either a community-altered culturally-tailored 8-month traditional foods and activities curriculum intervention or the standard regional Head Start program intervention.

Detailed Description

The Rural Alaska Community Action Program (RurAL CAP), which administers Head Start schools in rural Alaska, reports that 68% of Alaska Native children ages 3 to 5 years are overweight and 43% are obese. Diet, physical activity, and sleep hygiene are primary risk factors for childhood obesity, a risk factor for cardiometabolic diseases later in life. Notably, subclinical cardiovascular pathology can be detected as early as 3 years of age. Once living off the land and sea, Alaska Native (AN) people have suffered decades of colonization and in-migration, which have interfered with traditional food consumption, signaling a striking change in local food systems. Diet and physical activity are prime targets for early intervention, as taste preferences and exercise habits established in childhood forge lifelong adherence. Thus, investigators have designed More Outside Your Door, a multilevel intervention, which at the individual level builds on prior efforts to promote traditional diet and activities to decrease risk for obesity in Alaska Native preschoolers. At the family level, MOYD provides feedback to parents about their child's health screenings; at the school level, it features traditional foods, outdoor traditional physical activities, and a culturally centered curriculum. At the community level, it offers resources to improve the built environment for safe outdoor play that invites all community members to participate. In partnership, the Alaska Native Tribal Health Consortium, RurAL CAP, and collaborators will refine and test the effectiveness of MOYD at 12 Head Start preschools in the Yukon-Kuskokwim region: (1) investigators will use qualitative methods with Head Start staff, parents, and community Elders to optimally tailor MOYD for southwest Alaska communities; (2) investigators will conduct a stepped-wedge group-randomized trial to test its effect on children's diet, physical activity (PA), body mass index (BMI), and other risk factors for obesity-related chronic disease over three years. Primary outcomes are diet (classroom meals, actigraphy-based physical activity, and body mass index. Secondary outcomes include individual child level measures of hemoglobin levels and educational and developmental progress; parent report of diet, activity, and sleep at home; and measures of traditional foods/sugar-sweetened/processed foods by carbon and nitrogen stable isotope ratios using fingernail clippings. Investigators will also measure outcomes at the school level (classroom meals, outdoor time) and community level (objective data on use of play space). (3) Investigators will conduct a process evaluation using the RE-AIM framework. The Specific Aims are to (1) conduct preschool staff and parent/elder workgroups to refine the MOYD intervention for optimal effectiveness for obesity prevention among AN preschool children; (2) test the effectiveness of MOYD on a) diet, PA, outdoor time, and BMI; and b) improving other clinical and behavioral risk factors for obesity-related chronic disease in preschool children; and (3) Implement the RE-AIM framework to evaluate dissemination and implementation of the MOYD intervention in Head Start programs.

Conditions

Child Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Wedge 1

Four villages of 12 will be randomized into Wedge 1. Four of the remaining 8 villages will be randomized to Wedge 2. The remaining 4 villages will be Wedge 3.

Group Type: EXPERIMENTAL

Wedge 1

Intervention Type: BEHAVIORAL

Wedge1 will receive intervention consisting of culturally based physical activity module, built environment, community healthy lifestyle promotion

Wedge 2

While Wedge 1 is undergoing intervention, Wedges 2 \& 3 will act as controls.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Wedge 3

While Wedge 1 is undergoing intervention, Wedges 2 \& 3 will act as controls.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Wedge 1

Wedge1 will receive intervention consisting of culturally based physical activity module, built environment, community healthy lifestyle promotion

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• parent who identifies as Alaska Native (AN)
• parental consent
• enrolled in preschool in one of the12 participating Head Start programs
• present at school for health screenings

Exclusion Criteria

• lack of parental consent
• does not have a parent who is AN

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington State University

OTHER

Sponsor Role: collaborator

University of Alaska Anchorage

OTHER

Sponsor Role: collaborator

Alaska Native Tribal Health Consortium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alaska Native Tribal Health Consortium

Anchorage, Alaska, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Barb Stillwater

Role: CONTACT

bjstillwater@anthc.org

907-729-3644

Tim Thomas

Role: CONTACT

tkthomas@anthc.org

907-729-3095

Facility Contacts

Barb Stillwater, PhD

Role: primary

907 729 3644

Other Identifiers

R01HL168853

Identifier Type: NIH

Identifier Source: org_study_id

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