N/A
N=334
Reducing Sugared Fruit Drinks in Alaska Native Children
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05219448 ↗Enrolled (actual)
334
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Change in Added Sugar Intake Among Children — 11.7; 19.1 g/day — p=0.17
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Education and self-efficacy coaching (Behavioral)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Added Sugar Intake Among Children |
11.7; 19.1 | 0.17 |
| SECONDARY Change in Added Sugar Intake Among Caregivers |
13.6; 33.3; 8.5 | 0.60 |
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).
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.
Data sourced from ClinicalTrials.gov (NCT05219448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.