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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03601299
• Other study ID #: 5RO1NRO15417-02
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2018
• Est. completion date: July 31, 2022

Study information

• Verified date: July 2020
• Source: Alaska Native Tribal Health Consortium
• Contact: Timothy K Thomas, MD
• Phone: 907 729 3095
• Email: tkthomas[@]anthc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 804
• Est. completion date: July 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Other:
• Traditional food
Increasing traditional food consumption through Head start programs in Alaska

Locations

Country	Name	City	State
United States	Alaska Native Tribal Health Consortium	Anchorage	Alaska

Sponsors (5)

Lead Sponsor	Collaborator
Alaska Native Tribal Health Consortium	Rural Alaska Community Action Program, Inc. (RurAL CAP), University of Alaska Anchorage, University of Alaska Fairbanks, Yukon Kuskokwim Health Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index (BMI)	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
Primary	Traditional food content	Change in Percentage of total calories derived from traditional foods	Measured annually over 4 years of intervention