Back to Basics: Addressing Childhood Obesity Through Traditional Foods in Alaska

July 10, 2020 updated by: Alaska Native Tribal Health Consortium

Back to Basics is a mixed-methods intervention trial to reduce the prevalence of obese Alaska Native children by increasing the proportion of nutrient-dense traditional and non-traditional foods consumed, and decreasing consumption of sugar-sweetened beverages (SSBs). This 5-year intervention trial targeting 0-5 year olds is conducted in partnership with Rural Community Action Program, Inc. (RCAP) Head Start (HS), Early Head Start (EHS), and Parents as Teachers (PAT) programs in 12 rural Alaskan communities in the Yukon-Kuskokwim (YK) region, where each site is assigned to either a 9-month nutritional education and meal program intervention or a standard education and meal program repeating annually.

This intervention trial aims to increase consumption of local traditional foods and nutrient-dense non-traditional foods, decrease SSB consumption, and decrease prevalence of obesity in children 3-5 years old by: (1) adjusting the nutritional content of existing meal services provided by RCAP to children ages 3-5 years; (2) providing culturally relevant nutrition education to families of children 0-5 years; (3) developing local and community driven initiatives that provide knowledge and skills and engage families in the gathering and preparing of local traditional foods; and (4) incorporating available and emerging resources (e.g. Fish/Farm-to- Schools) to increase integration of traditional foods into the diet.

Phase 1 involves the collection and analysis of formative and baseline data to help guide the intervention in Phase 2.

Phase 1 includes:

  1. Gathering baseline height/weight and food/SSB consumption data previously collected on children ages 0-5 years enrolled in YK RCAP programs.
  2. Conducting formative studies in the 12 YK communities to better understand attitudes towards childhood obesity and barriers/enablers to traditional foods consumption
  3. Creating/integrating a traditional foods-focused nutrition curriculum into RCAP menu programs in YK communities.

5. Work to expand the "Fish to Schools" and "Farm to Preschool" programs into YK RCAP HS programs.

Phase 2 includes implementing:

  1. A physical activity curriculum in HS programs in all communities
  2. A traditional food in HS menu program in intervention communities
  3. A home-based nutrition program in intervention communities
  4. A mechanism to document traditional foods important to each community

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

804

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

Study Contact Backup

Study Locations

    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Alaska Native Tribal Health Consortium
        • Contact:
          • Kathy Koller, PhD
          • Phone Number: 907-729-3644

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • for the Focus Group Discussions: Consenting Alaska Native residents of the 12 communities involved in the study, aged 18 and over.
  • for the intervention study: Upon parental or guardian consent, Alaska Native residents of the 12 communities involved in the study, aged 0-5 years and enrolled in the RurAL CAP Head start, Early Head start, or Parents as Teachers, programs

Exclusion Criteria:

  • None

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
Experimental: Traditional food arm
Traditional food-focused menu
Increasing traditional food consumption through Head start programs in Alaska
No Intervention: Non-intervention arm
Standard RurAL CAP menu

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index (BMI)
Time Frame: Measured annually over 4 years of intervention
Change in Proportion of AN children 3-5 years old with a BMI greater than or equal to the 95th percentile
Measured annually over 4 years of intervention
Traditional food content
Time Frame: Measured annually over 4 years of intervention
Change in Percentage of total calories derived from traditional foods
Measured annually over 4 years of intervention

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Timothy K Thomas, MD, Alaska Native Tribal Health Consortium
  • Study Director: Kathy Koller, PhD, Alaska Native Tribal Health Consortium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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 (Actual)

May 14, 2018

Primary Completion (Anticipated)

April 30, 2022

Study Completion (Anticipated)

July 31, 2022

Study Registration Dates

First Submitted

June 14, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 5RO1NRO15417-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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