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

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ClinicalTrials.gov Identifier: NCT03986632
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborators:
Pacific Institute for Research and Evaluation
University of Alaska Anchorage
State of Alaska Department of Health and Social Services
Grand Valley State University
Alaska Native Tribal Health Consortium
Information provided by (Responsible Party):
Andrea Bersamin, University of Alaska Fairbanks

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.


Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: Tundra Gifts Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2022

Arm Intervention/treatment
Experimental: Tundra gifts program Behavioral: Tundra Gifts
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.

No Intervention: Comparison



Primary Outcome Measures :
  1. Change in age- and sex-specific BMI percentiles and z-scores [ Time Frame: twice annually for 3 years ]
  2. 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

  3. Change in child intake of vegetables and fruit [ Time Frame: twice annually for 3 years ]
    Skin carotenoid meter using reflection spectroscopy (veggie-meter)

  4. 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

  5. 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

  6. Change in child screen time [ Time Frame: twice annually for 3 years ]
    Screen time questionnaire

  7. Change in child physical activity [ Time Frame: twice annually for 3 years ]
    Physical activity questionnaire


Secondary Outcome Measures :
  1. Change in adult attitudes and beliefs around healthy eating and active lifestyle [ Time Frame: twice annually for 3 years ]
    Attitudes and beliefs questionnaire

  2. Change in adult BMI [ Time Frame: twice annually for 3 years ]
  3. Change in adult intake of vegetables and fruit [ Time Frame: twice annually for 3 years ]
    skin carotenoid meter using reflection spectroscopy (veggie-meter)



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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986632


Contacts
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Contact: Andrea Bersamin, PhD (907)474-6129 abersamin@alaska.edu

Sponsors and Collaborators
University of Alaska Fairbanks
Pacific Institute for Research and Evaluation
University of Alaska Anchorage
State of Alaska Department of Health and Social Services
Grand Valley State University
Alaska Native Tribal Health Consortium

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Responsible Party: Andrea Bersamin, Associate Professor, University of Alaska Fairbanks
ClinicalTrials.gov Identifier: NCT03986632     History of Changes
Other Study ID Numbers: 2018-69001-27544
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrea Bersamin, University of Alaska Fairbanks:
Healthy Eating
Alaska Native
Traditional Foods

Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms