- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03601299
Back to Basics: Addressing Childhood Obesity Through Traditional Foods in Alaska
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:
- Gathering baseline height/weight and food/SSB consumption data previously collected on children ages 0-5 years enrolled in YK RCAP programs.
- Conducting formative studies in the 12 YK communities to better understand attitudes towards childhood obesity and barriers/enablers to traditional foods consumption
- 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:
- A physical activity curriculum in HS programs in all communities
- A traditional food in HS menu program in intervention communities
- A home-based nutrition program in intervention communities
- A mechanism to document traditional foods important to each community
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Timothy K Thomas, MD
- Phone Number: 907 729 3095
- Email: tkthomas@anthc.org
Study Contact Backup
- Name: Kathy Koller, PhD
- Phone Number: 907 729 3644
- Email: kkoller@anthc.org
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
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Collaborators
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
Study record dates
Study Major Dates
Study Start (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5RO1NRO15417-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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