Recruiting

Diet Intervention

Sponsor:

Alaska Native Tribal Health Consortium

Code:

NCT06303544

Conditions

Child Obesity

Eligibility Criteria

Sex: All

Age: 3 - 5

Healthy Volunteers: Accepted

Interventions

Wedge 1

Study Details

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

Study ID

NCT06303544

Start date

Sep 1, 2024

Status verified date

Jan, 2025

Completion date

May 30, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 5

Healthy Volunteers: Accepted

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 Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Wedge 1

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

Primary outcome measure

  • BMI [ Time Frame: 3 years ]
  • Physical activity [ Time Frame: 3 years ]
  • Outdoor time [ Time Frame: 3 years ]
  • Sleep quality [ Time Frame: 3 years ]
  • Fingernail nitrogen & carbon stable isotope ratios [ Time Frame: 3 years ]

Central Contacts and Locations

Locations

Alaska Native Tribal Health Consortium

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Barb Stillwater, PhD

907 729 3644

More Information

Sponsor

Alaska Native Tribal Health Consortium

Last update posted

Jan 29, 2025

Last verified

Jan, 2025

Keywords

  • Head Start, CBPR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alaska Native Tribal Health Consortium on 2025-01-29.