Clinical trial NCT03986632: Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities
Official title: Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Childhood Obesity
Keywords: Healthy Eating
Alaska Native
Traditional Foods
Lead sponsor: University of Alaska Fairbanks
Sponsor class: OTHER
Collaborators: name: Pacific Institute for Research and Evaluation
name: University of Alaska Anchorage
name: State of Alaska Department of Health and Social Services
name: Grand Valley State University
name: Alaska Native Tribal Health Consortium
First posted: 2019-06-14
Enrollment: 500
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The long-term goal of this community based participatory research project is to prevent obesity in 3-5 year old Alaska Native children in remote communities.

Investigators will design and evaluate a culturally responsive, home-focused intervention, Tundra Gifts, that links early childhood education programming (i.e. Head Start) and federal food assistance programs (i.e. WIC and SNAP) with primary caregivers to support healthy eating and an active lifestyle using a cluster-randomized design. The intervention integrates behavior change theory with Indigenous traditional knowledge. Primary caregivers will attend monthly interactive education session, receive a monthly gift basket that includes resources and supplies to support behavior change at home and receive ongoing social support through a Facebook site. Investigators will also evaluate key process indicators of Tundra Gifts to understand the impact on outcomes of variations in persons and settings and to enhance the generalizability of findings.


Eligibility criteria: Inclusion Criteria:

* 3-5 year old children enrolled in Head Start and their primary caregiver in Yup'ik Alaska Native communities

Primary outcomes:
measure: Change in age- and sex-specific BMI percentiles and z-scores
timeFrame: twice annually for 3 years
measure: Change in child intake of vegetables and fruit
timeFrame: twice annually for 3 years
measure: Change in child intake of vegetables and fruit
timeFrame: twice annually for 3 years
measure: Change in child intake of sugar sweetened beverages
timeFrame: twice annually for 3 years
measure: Change in child intake of sugar sweetened beverages
timeFrame: twice annually for 3 years
measure: Change in child screen time
timeFrame: twice annually for 3 years
measure: Change in child physical activity
timeFrame: twice annually for 3 years
Secondary outcomes:
measure: Change in adult attitudes and beliefs around healthy eating and active lifestyle
timeFrame: twice annually for 3 years
measure: Change in adult BMI
timeFrame: twice annually for 3 years
measure: Change in adult intake of vegetables and fruit
timeFrame: twice annually for 3 years
Other outcomes:
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Study officials:
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