Clinical trial NCT05219448: Reducing Sugared Fruit Drinks in Alaska Native Children
Official title: Reducing Sugared Fruit Drinks in Alaska Native Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Alaska Native
children
sugared fruit drinks
sugar sweetened beverages
oral health
dental
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: University of Alaska Fairbanks
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2022-02-02
Enrollment: 334
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Added Sugar Intake Among Children
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in Added Sugar Intake Among Caregivers
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington School of Dentistry
state: Washington
Study officials:
affiliation: University of Washington
name: Donald L Chi, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: