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Completed

NCT Number: NCT05219448

Reducing Sugared Fruit Drinks in Alaska Native Children

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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Key information

Conditions

Age range

1 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington School of Dentistry

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education and self-efficacy coaching

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.

Primary outcomes

  1. Change in Added Sugar Intake Among Children

    Time frame: 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 outcomes

  1. Change in Added Sugar Intake Among Caregivers

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)
  • University of Alaska Fairbanks

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 2, 2022
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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