Reducing Sugared Fruit Drinks in Alaska Native Children

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-06

Study Completion Date

2024-03-13

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).

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

There are 2 arms in the study. In Communities A and B, a total of 136 children (and at least one primary caregiver for each child) will be recruited for the intervention and outcomes measured over 12 months. In Community C, 56 children (and at least one primary caregiver for each child) 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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

All raw data provided to the statistician will include a participant-level variable indicating the community in which the participant lives.

Study Groups

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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.

Group Type EXPERIMENTAL

Education and self-efficacy coaching

Intervention Type BEHAVIORAL

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.

Comparison

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Education and self-efficacy coaching

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.

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes