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Clinical Trials/NCT03986632
NCT03986632UnknownNot Applicable

Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities

University of Alaska Fairbanks0 sites500 target enrollmentStarted: September 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
500
Primary Endpoint
Change in child physical activity

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
3 Years to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Tundra gifts program

Experimental

Intervention: Tundra Gifts (Behavioral)

Comparison

No Intervention

Outcomes

Primary Outcomes

Change in child physical activity

Time Frame: twice annually for 3 years

Physical activity questionnaire

Change in age- and sex-specific BMI percentiles and z-scores

Time Frame: twice annually for 3 years

Change in child intake of vegetables and fruit

Time Frame: twice annually for 3 years

24-hour recall in combination with a 2-day food record

Change in child intake of sugar sweetened beverages

Time Frame: twice annually for 3 years

Hair biomarker of sugar using N and C stable isotope ratios

Change in child screen time

Time Frame: twice annually for 3 years

Screen time questionnaire

Secondary Outcomes

  • Change in adult attitudes and beliefs around healthy eating and active lifestyle(twice annually for 3 years)
  • Change in adult BMI(twice annually for 3 years)
  • Change in adult intake of vegetables and fruit(twice annually for 3 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Andrea Bersamin

Associate Professor

University of Alaska Fairbanks

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