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

June 12, 2019 updated by: Andrea Bersamin, University of Alaska Fairbanks

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Comparison
Experimental: Tundra gifts program
Tundra Gifts is a home-focused intervention delivered by community health workers (CHW) that focuses on promoting healthy eating and an active lifestyle among 3-5 year olds through family and community partnerships. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in age- and sex-specific BMI percentiles and z-scores
Time Frame: twice annually for 3 years
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
twice annually for 3 years
Change in child intake of vegetables and fruit
Time Frame: twice annually for 3 years
Skin carotenoid meter using reflection spectroscopy (veggie-meter)
twice annually for 3 years
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
twice annually for 3 years
Change in child intake of sugar sweetened beverages
Time Frame: twice annually for 3 years
24-hour recall in combination with a 2-day food record
twice annually for 3 years
Change in child screen time
Time Frame: twice annually for 3 years
Screen time questionnaire
twice annually for 3 years
Change in child physical activity
Time Frame: twice annually for 3 years
Physical activity questionnaire
twice annually for 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in adult attitudes and beliefs around healthy eating and active lifestyle
Time Frame: twice annually for 3 years
Attitudes and beliefs questionnaire
twice annually for 3 years
Change in adult BMI
Time Frame: twice annually for 3 years
twice annually for 3 years
Change in adult intake of vegetables and fruit
Time Frame: twice annually for 3 years
skin carotenoid meter using reflection spectroscopy (veggie-meter)
twice annually for 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

May 30, 2022

Study Completion (Anticipated)

May 30, 2022

Study Registration Dates

First Submitted

June 2, 2019

First Submitted That Met QC Criteria

June 12, 2019

First Posted (Actual)

June 14, 2019

Study Record Updates

Last Update Posted (Actual)

June 14, 2019

Last Update Submitted That Met QC Criteria

June 12, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-69001-27544

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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