- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03986632
Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andrea Bersamin, PhD
- Phone Number: (907)474-6129
- Email: abersamin@alaska.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 3-5 year old children enrolled in Head Start and their primary caregiver in Yup'ik Alaska Native communities
Study Plan
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
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-69001-27544
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Childhood Obesity
-
Universiteit LeidenWageningen University; Nutricia, Inc.; Danone ResearchCompletedChildhood Obesity | Childhood Overweight | Vegetable Acceptance in Early ChildhoodNetherlands
-
Vanderbilt University Medical CenterActive, not recruitingPediatric Obesity | Childhood Obesity | Childhood Onset ObesityUnited States
-
Tehran University of Medical SciencesUnknownChildhood Obesity PreventionIran, Islamic Republic of
-
Oregon State UniversityCompletedChildhood Obesity Prevention
-
The Miriam HospitalHassenfeld Child Health Innovation InstituteCompletedChildhood Obesity PreventionUnited States
-
Fundacion para la Formacion e Investigacion Sanitarias...UnknownChildhood Obesity PreventionSpain
-
Tampere UniversitySeinajoki Central Hospital; Tampere University Hospital; Foundation for Paediatric... and other collaboratorsCompleted
-
Cornell UniversityCompletedChildhood Obesity Prevention
-
Harokopio UniversityCompletedPrevention of Childhood ObesityGreece
-
University of Alabama at BirminghamCompletedObesity, Childhood | Overweight, ChildhoodUnited States