Anchorage, Alaska 99508


Purpose:

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


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:


Study is Available At:


Original ID:

5RO1NRO15417-02


NCT ID:

NCT03601299


Secondary ID:


Study Acronym:


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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Alaska Native Tribal Health Consortium


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

804


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Timothy K Thomas, MD
Principal Investigator
Alaska Native Tribal Health Consortium
Primary Contact:Timothy K Thomas, MD
907 729 3095
tkthomas@anthc.org
Backup Contact:Kathy Koller, PhD
907 729 3644
kkoller@anthc.org

Study Dates

Start Date:May 14, 2018
Completion Date:July 31, 2022
Completion Type:Anticipated
Primary Completion Date:April 30, 2022
Primary Completion Type:Anticipated
Verification Date:July 2018
Last Changed Date:July 24, 2018
First Received Date:June 14, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Traditional food content
Time Frame:Measured annually over 4 years of intervention
Safety Issues:False
Description:Change in Percentage of total calories derived from traditional foods
Outcome Type:Primary Outcome
Measure:Body Mass Index (BMI)
Time Frame:Measured annually over 4 years of intervention
Safety Issues:False
Description:Change in Proportion of AN children 3-5 years old with a BMI greater than or equal to the 95th percentile

Study Interventions

Intervention Type:Other
Name:Traditional food
Description:Increasing traditional food consumption through Head start programs in Alaska
Arm Name:Traditional food arm

Study Arms

Study Arm Type:Experimental
Arm Name:Traditional food arm
Description:Traditional food-focused menu
Study Arm Type:No Intervention
Arm Name:Non-intervention arm
Description:Standard RurAL CAP menu

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Alaska Native Tribal Health Consortium
Agency Class:Other
Agency Type:Collaborator
Agency Name:Rural Alaska Community Action Program, Inc. (RurAL CAP)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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