Back to Basics: Addressing Childhood Obesity Through Traditional Foods in Alaska
Primary Purpose
Obesity
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional food
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
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
Sites / Locations
- Alaska Native Tribal Health ConsortiumRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Traditional food arm
Non-intervention arm
Arm Description
Traditional food-focused menu
Standard RurAL CAP menu
Outcomes
Primary Outcome Measures
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
Traditional food content
Change in Percentage of total calories derived from traditional foods
Secondary Outcome Measures
Full Information
NCT ID
NCT03601299
First Posted
June 14, 2018
Last Updated
July 10, 2020
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
1. Study Identification
Unique Protocol Identification Number
NCT03601299
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2018 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
Gathering baseline height/weight and food/SSB consumption data previously collected on children ages 0-5 years enrolled in YK RCAP programs.
Conducting formative studies in the 12 YK communities to better understand attitudes towards childhood obesity and barriers/enablers to traditional foods consumption
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:
A physical activity curriculum in HS programs in all communities
A traditional food in HS menu program in intervention communities
A home-based nutrition program in intervention communities
A mechanism to document traditional foods important to each community
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
804 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Traditional food arm
Arm Type
Experimental
Arm Description
Traditional food-focused menu
Arm Title
Non-intervention arm
Arm Type
No Intervention
Arm Description
Standard RurAL CAP menu
Intervention Type
Other
Intervention Name(s)
Traditional food
Intervention Description
Increasing traditional food consumption through Head start programs in Alaska
Primary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
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
Title
Traditional food content
Description
Change in Percentage of total calories derived from traditional foods
Time Frame
Measured annually over 4 years of intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy K Thomas, MD
Phone
907 729 3095
Email
tkthomas@anthc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kathy Koller, PhD
Phone
907 729 3644
Email
kkoller@anthc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy K Thomas, MD
Organizational Affiliation
Alaska Native Tribal Health Consortium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathy Koller, PhD
Organizational Affiliation
Alaska Native Tribal Health Consortium
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Native Tribal Health Consortium
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Koller, PhD
Phone
907-729-3644
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34350814
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.
Results Reference
derived
Learn more about this trial
Back to Basics: Addressing Childhood Obesity Through Traditional Foods in Alaska
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