Reducing Sugared Fruit Drinks in Alaska Native Children

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Behavioral: Education and self-efficacy coaching

• Registration Number: NCT05219448
• Lead Sponsor: University of Washington

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-01-07
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-02-02
• Study Start: 2022-09-06
• Primary Completion: 2023-03-28
• Study Completion: 2024-03-13
• Results First Submitted: 2024-03-28
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Results First Posted: 2024-07-29
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 334

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education and self-efficacy coaching	Education and self-efficacy coaching	This arm will receive education, behavior change support in the form of self-efficacy coaching, and introduction of sugar-free water enhancers.

Primary Outcome Measures

Name	Time	Method
Change in Added Sugar Intake Among Children	Baseline to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Added Sugar Intake Among Caregivers	Baseline to 6 months	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.

Trial Locations

Locations (1)

University of Washington School of Dentistry; 🇺🇸 Seattle, Washington, United States