Reducing Sugared Fruit Drinks in Alaska Native Children

Study Overview
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Brief Summary
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This study in Alaska will test whether providing sugar-free alternatives to sugared fruit drinks and introducing education and social support will help families and children to reduce the amount of sugared fruit drinks consumed (measured through the primary outcome of added sugar intake).

Detailed Description
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Alaska Native children consume an average of 50 teaspoons of sugar per day and most of this added sugar is from fruit drinks like Tang and Kool-Aid. The goal of this community-based behavioral trial is to reduce added sugar intake in Alaska Native children. In Communities A and B, a total of 136 children ages 1-11 years will be recruited for a 6-month culturally-adapted, 5-session intervention consisting of video-based health education and self-efficacy coaching delivered in person by an indigenous Community Health Worker. There will be 4 brief check-ins to provide social support. Local stores have been recruited to carry sugar-free fruit drinks. In Community C, 56 children will be recruited to a no treatment control group. Outcomes will be measured at baseline, 1, 3, 6, and 12 months.

Official Title
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Reducing Sugared Fruit Drinks in Alaska Native Children

Conditions
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Healthy

Intervention / Treatment
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* Behavioral: Education and self-efficacy coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child must be older than age 1 year but less than age 12 years at time of enrollment. Multiple children from the same family are eligible; Child must live in one of the study communities at baseline; Child's parent or primary caregiver must of Yup'ik descent, be age 18 years or older, and willing to provide written consent to study procedures; Child participant(s) ages 8 to 11 years must be willing to provide written assent to study procedures; Willing to comply with all study procedures and be available for the duration of the study. Exclusion Criteria: Severe medical condition that would prevent the child from completing the study procedures; Allergy to sucralose or acesulfame potassium (sweeteners in the sugar-free water enhancers) as defined by parent report of any known allergies; Sulfa drug allergy (potential hypersensitivity to acesulfame potassium); Member of the same household as the Community Health Worker who will be delivering the intervention.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are 2 arms in the study. In Communities A and B, a total of 136 participants will be recruited for the intervention and outcomes measured over 12 months. In Community C, 56 children will be recruited to a control group where outcomes are measured over 12 months but the intervention is not delivered until the study data collection period is over.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education and self-efficacy coaching<br>This arm will receive education, behavior change support in the form of self-efficacy coaching, and introduction of sugar-free water enhancers. | Behavioral: Education and self-efficacy coaching<br>* Children and their caregiver(s) in the intervention communities will receive a culturally-adapted, 5-session program consisting of video-based health education and self-efficacy coaching delivered by an indigenous Community Health Worker. Families will be introduced to sugar-free water enhancers that are commercially available and come in the same flavors as regular Tang and Kool-Aid. The sessions will include conversations on related topics, interactive hands-on activities, and homework assignments. Additionally, four brief check-ins will keep families engaged. Local stores in the intervention communities only will carry the sugar-free water enhancers that are highlighted in the health education.<br>|
| No Intervention: Comparison<br>This arm will have the outcomes assessed but will not receive relevant parts of the intervention (education, behavior change support, and introduction of sugar-free water enhancers) until the end of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in added sugar intake among children | Added sugar intake among children will be measured with a validated hair biomarker, generated from stable carbon and nitrogen isotope ratios of hair using coefficients for added sugar determined specifically for the Yup'ik population. The investigators will measure added sugar in grams of added sugar per day. | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in added sugar intake among caregivers | Added sugar intake among caregivers will be measured with a validated hair biomarker, generated from stable carbon and nitrogen isotope ratios of hair, based on coefficients for added sugar determined specifically for the Yup'ik population. The investigators will measure added sugar in grams of added sugar per day. | Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alaska Native, children, sugared fruit drinks, sugar sweetened beverages, oral health, dental