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

NCT06303544 | Recruiting

• 1 other identifier: R01HL168853
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Obesity

Keywords

Head Start, CBPR

Outcome Measures

Primary Outcomes (5)

• BMI

  Body mass index (kg/m2)

  3 years

• Physical activity

  Measured via accelerometers (minutes)

  3 years

• Outdoor time

  Time (minutes) spent outdoors by children

  3 years

• Sleep quality

  Hours of sleep measured by survey

  3 years

• Fingernail nitrogen & carbon stable isotope ratios

  Measurements of traditional food intake and added sugar intake

  3 years

Study Arms (3)

Wedge 1

EXPERIMENTAL

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.

Behavioral: Wedge 1

Wedge 2

NO INTERVENTION

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

Wedge 3

NO INTERVENTION

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

Interventions

Wedge 1 BEHAVIORAL

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

Wedge 1

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Alaska Native Tribal Health Consortium: lead
• Washington State University: collaborator
• University of Alaska Anchorage: collaborator

Study Sites (1)

Alaska Native Tribal Health Consortium

Anchorage, Alaska, 99508, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Barb Stillwater

CONTACT

907-729-3644; bjstillwater@anthc.org

Tim Thomas

CONTACT

907-729-3095; tkthomas@anthc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Wedge design using repeated cross sectional samples of Head Start preschool students

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: March 12, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)