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CompletedNCT03601299Updated Jul 31, 2024

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

An interventional study of Traditional food in Obesity, sponsored by Alaska Native Tribal Health Consortium. Completed at 1 site in United States. Open to participants aged 0 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Alaska Native Tribal Health Consortium · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
416
Allocation
Randomized
Ages
0 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Obesity

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03

In context

Obesity

6,578 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 416 is above the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Alaska Native Tribal Health Consortium is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
416 participants (actual)

Study arms

  • Experimental
    Traditional food arm

    Traditional food-focused menu

    Other: Traditional food

  • No intervention
    Non-intervention arm

    Standard RurAL CAP menu

Interventions

  • OtherTraditional food

    Increasing traditional food consumption through Head start programs in Alaska

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Measured annually over 4 years of intervention

  2. Traditional food content

    Change in Percentage of total calories derived from traditional foods

    Time frame: Measured annually over 4 years of intervention

07

Study locations

1 site
  • Alaska Native Tribal Health Consortium
    Anchorage, Alaska 99508, United States
08

References and documents

Publications

  • 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. PubMed 37703513 ↗
  • 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. PubMed 36473164 ↗
  • 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. PubMed 34350814 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2018 to primary completion in Apr 2023, 59 months.

Of 2,253 non-industry interventional studies with no phase under Obesity, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's 59 months is above that.

Counting every sponsor, half of 2,351 studies reached it within 26 months; a quarter within 11 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 14, 2018
First posted
Jul 26, 2018
StartActual
May 14, 2018
Primary completionActual
Apr 30, 2023
CompletionActual
Jul 31, 2023
Last update
Jul 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03601299
Lead sponsor
Alaska Native Tribal Health Consortium
Collaborators
Rural Alaska Community Action Program, Inc. (RurAL CAP), University of Alaska Fairbanks, University of Alaska Anchorage, Yukon Kuskokwim Health Corporation
Responsible party
Sponsor
First posted
Jul 26, 2018
Start date
May 14, 2018
Primary completion
Apr 30, 2023
Completion
Jul 31, 2023
Last update
Jul 31, 2024

Study contacts

Timothy K Thomas, MD
principal investigator · Alaska Native Tribal Health Consortium
Kathy Koller, PhD
study director · Alaska Native Tribal Health Consortium

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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