More Outside Your Door: A Diet/Physical Activity Intervention to Decrease Risk of Obesity in Alaska Native Preschoolers (MOYD)

More Outside Your Door (MOYD): A Multilevel Intervention Promoting Traditional Diet and Physical Activity to Decrease Risk of Obesity in Alaska Native (AN) Preschoolers

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Child Obesity
• Intervention / Treatment: Behavioral: Wedge 1

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.

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barb Stillwater; Phone Number: 907-729-3644; Email: bjstillwater@anthc.org
• Study Contact Backup: Name: Tim Thomas; Phone Number: 907-729-3095; Email: tkthomas@anthc.org

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Native Tribal Health Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Wedge 1; Wedge1 will receive intervention consisting of culturally based physical activity module, built environment, community healthy lifestyle promotion
No Intervention: Wedge 2; While Wedge 1 is undergoing intervention, Wedges 2 & 3 will act as controls.
No Intervention: Wedge 3; While Wedge 1 is undergoing intervention, Wedges 2 & 3 will act as controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alaska Native Tribal Health Consortium
• Collaborators: Washington State University; University of Alaska Anchorage

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Head Start, CBPR
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: R01HL168853 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Any shared data will be deidentified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No