Reducing Sugared Fruit Drinks in Alaska Native Children

NCT05219448 | Completed Results DMC

• 2 other identifiers: STUDY00009185U01DE027629
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

Alaska Native; children; sugared fruit drinks; sugar sweetened beverages; oral health; dental

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Added Sugar Intake Among Caregivers

  Baseline to 6 months

Study Arms (2)

Education and self-efficacy coaching

EXPERIMENTAL

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

Comparison

NO INTERVENTION

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.

Interventions

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.

Education and self-efficacy coaching

Eligibility Criteria

• Age: 1 Year - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• University of Alaska Fairbanks: collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of Washington School of Dentistry

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Chi DL, Lewis FM, Weinstein P, Mancl L, Milgrom P, Edwards T, Coldwell S, O'Brien D, Bersamin A, Hopkins S, Orr E, Rivera P, Lenaker D, Sylvetsky A, Gittelsohn J, Walter P, Randall CL, Wiseman D, Dock A, Ko A, Orack J, Nemawarkar D, Panchal S, Soper J, Hill CM, Kerr D, Nguyen DP, Chen CY, MacLachlan E. Healthy Drinks, Healthy Teeth - Ciunerkaq Tanqigtuq (The Future is Bright): A study protocol for a community-based, non-randomized sociobehavioral trial to reduce added sugar intake in Alaska Native Yup'ik children in the Yukon-Kuskokwim Delta. Contemp Clin Trials. 2024 Dec;147:107734. doi: 10.1016/j.cct.2024.107734. Epub 2024 Nov 1.

  PMID: 39489399 DERIVED

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Limitations and Caveats

Allocation was not randomized. Communities were allocated to the intervention arm vs. control arm based on readiness to participate.

Results Point of Contact

• Title: Dr. Donald L. Chi
• Organization: University of Washington

dchi@uw.edu

206-616-4332

Study Officials

• Donald L Chi, DDS, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All raw data provided to the statistician will include a participant-level variable indicating the community in which the participant lives.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Oral Health Sciences

Model Details: 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.

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 2, 2022
• Study Start: September 6, 2022
• Primary Completion: March 28, 2023
• Study Completion: March 13, 2024
• Last Updated: July 29, 2024
• Results First Posted: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)