NCT03601299

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. 1.Gathering baseline height/weight and food/SSB consumption data previously collected on children ages 0-5 years enrolled in YK RCAP programs.
  2. 2.Conducting formative studies in the 12 YK communities to better understand attitudes towards childhood obesity and barriers/enablers to traditional foods consumption
  3. 3.Creating/integrating a traditional foods-focused nutrition curriculum into RCAP menu programs in YK communities.
  4. 4.A physical activity curriculum in HS programs in all communities
  5. 5.A traditional food in HS menu program in intervention communities
  6. 6.A home-based nutrition program in intervention communities
  7. 7.A mechanism to document traditional foods important to each community

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 14, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

5 years

First QC Date

June 14, 2018

Last Update Submit

July 30, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • Traditional food content

    Change in Percentage of total calories derived from traditional foods

    Measured annually over 4 years of intervention

Study Arms (2)

Traditional food arm

EXPERIMENTAL

Traditional food-focused menu

Other: Traditional food

Non-intervention arm

NO INTERVENTION

Standard RurAL CAP menu

Interventions

Increasing traditional food consumption through Head start programs in Alaska

Traditional food arm

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alaska Native Tribal Health Consortium

Anchorage, Alaska, 99508, United States

Location

Related Publications (3)

  • Ohle KA, Koller KR, Walch AK, Lee FR, Palmer L, Nu J, Thomas TK. Alaska Native Parents' Decision-Making About Food, Beverages, and Screen Time for Young Children: Formative Insights From the "Got Neqpiaq?" Project. Fam Community Health. 2023 Oct-Dec 01;46(4):250-258. doi: 10.1097/FCH.0000000000000370.

  • Hill CM, Paschall MJ, Koller KR, Day GM, Lee FR, O'Brien DM, King DK, Palmer L, Thomas TK, Bersamin A. Obesity Prevalence and Dietary Factors Among Preschool-Aged Head Start Children in Remote Alaska Native Communities: Baseline Data from the "Got Neqpiaq?" Study. Child Obes. 2023 Oct;19(7):498-506. doi: 10.1089/chi.2022.0143. Epub 2022 Dec 5.

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Timothy K Thomas, MD

    Alaska Native Tribal Health Consortium

    PRINCIPAL INVESTIGATOR
  • Kathy Koller, PhD

    Alaska Native Tribal Health Consortium

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2018

First Posted

July 26, 2018

Study Start

May 14, 2018

Primary Completion

April 30, 2023

Study Completion

July 31, 2023

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations