Reducing Sugared Fruit Drinks in Alaska Native Children

Healthy Clinical Trial

Official title:

Reducing Sugared Fruit Drinks in Alaska Native Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05219448
• Other study ID #: STUDY00009185
• Secondary ID: U01DE027629
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: May 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 201
• Est. completion date: October 1, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	University of Washington School of Dentistry	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	National Institute of Dental and Craniofacial Research (NIDCR), University of Alaska Fairbanks

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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