Clinical trial NCT03601299: Back to Basics: Addressing Childhood Obesity Through Traditional Foods in Alaska
Official title: Back to Basics: Addressing Childhood Obesity Through Traditional Foods in Alaska
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Alaska Native Tribal Health Consortium
Sponsor class: OTHER
Collaborators: name: Rural Alaska Community Action Program, Inc. (RurAL CAP)
name: University of Alaska Fairbanks
name: University of Alaska Anchorage
name: Yukon Kuskokwim Health Corporation
First posted: 2018-07-26
Enrollment: 416
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Measured annually over 4 years of intervention
measure: Traditional food content
timeFrame: Measured annually over 4 years of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Native Tribal Health Consortium
state: Alaska
Study officials:
affiliation: Alaska Native Tribal Health Consortium
name: Timothy K Thomas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alaska Native Tribal Health Consortium
name: Kathy Koller, PhD
role: STUDY_DIRECTOR
References:
citation: Koller KR, Flanagan CA, Nu J, Lee FR, Desnoyers C, Walch A, Alexie L, Bersamin A, Thomas TK. Storekeeper perspectives on improving dietary intake in 12 rural remote western Alaska communities: the "Got Neqpiaq?" project. Int J Circumpolar Health. 2021 Jan 1;80(1):1961393. doi: 10.1080/22423982.2021.1961393.