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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Education and self-efficacy coaching

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 Type: Interventional
• Enrollment (Actual): 334
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Added Sugar Intake Among Caregivers	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.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR); University of Alaska Fairbanks
• Investigators: Principal Investigator: Donald L Chi, DDS, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Actual): March 28, 2023
• Study Completion (Actual): March 13, 2024

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: children; oral health; Alaska Native; dental; sugar sweetened beverages; sugared fruit drinks
• Other Study ID Numbers: STUDY00009185; U01DE027629 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No