Reducing Sugared Fruit Drinks in Alaska Native Children

University of Washington

Status: Completed

Conditions: Healthy

Treatments: Behavioral: Education and self-efficacy coaching

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05219448

U01DE027629 (U.S. NIH Grant/Contract)

STUDY00009185

Details and patient eligibility

About

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).

Full 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.

Enrollment: 334 patients

Sex: All

Ages: 1 to 11 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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334 participants in 2 patient groups

Education and self-efficacy coaching

Experimental group

Description:

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

Treatment:

Behavioral: Education and self-efficacy coaching

Comparison

No Intervention group

Description:

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.