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

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ClinicalTrials.gov Identifier: NCT03601299
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : July 14, 2020
Sponsor:
Collaborators:
Rural Alaska Community Action Program, Inc. (RurAL CAP)
University of Alaska Fairbanks
University of Alaska Anchorage
Yukon Kuskokwim Health Corporation
Information provided by (Responsible Party):
Alaska Native Tribal Health Consortium

Study Description
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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

Condition or disease Intervention/treatment Phase
Obesity Other: Traditional food Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 804 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Back to Basics: Addressing Childhood Obesity Through Traditional Foods in Alaska
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : July 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Traditional food arm
Traditional food-focused menu
 Other: Traditional food
Increasing traditional food consumption through Head start programs in Alaska
No Intervention: Non-intervention arm
Standard RurAL CAP menu


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Traditional food content [ Time Frame: Measured annually over 4 years of intervention ]
    Change in Percentage of total calories derived from traditional foods


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601299


Contacts
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Contact: Timothy K Thomas, MD 907 729 3095 tkthomas@anthc.org
Contact: Kathy Koller, PhD 907 729 3644 kkoller@anthc.org

Locations
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United States, Alaska
Alaska Native Tribal Health Consortium Recruiting
Anchorage, Alaska, United States, 99508
Contact: Kathy Koller, PhD    907-729-3644      
Sponsors and Collaborators
Alaska Native Tribal Health Consortium
Rural Alaska Community Action Program, Inc. (RurAL CAP)
University of Alaska Fairbanks
University of Alaska Anchorage
Yukon Kuskokwim Health Corporation
Investigators
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Principal Investigator: Timothy K Thomas, MD Alaska Native Tribal Health Consortium
Study Director: Kathy Koller, PhD Alaska Native Tribal Health Consortium
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alaska Native Tribal Health Consortium
ClinicalTrials.gov Identifier: NCT03601299    
Other Study ID Numbers: 5RO1NRO15417-02
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
 Nutrition Disorders
Overweight
Body Weight