Clinical trial NCT06714929: Advancing Water Security: A Community Participatory School-Based Hydration Intervention
Official title: Advancing Water Security: A Community Participatory School-Based Hydration Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Caries
Obesity Prevention
Keywords: hydration
water
sugar-sweetened beverages
dental caries
overweight and obesity
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-12-04
Enrollment: 7200
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge cluster randomized controlled trial; 4 groups of schools sequentially receive the intervention each year over 3 years. Assessments of all 12 schools occur at all timepoints over the 3 years.
Primary purpose: PREVENTION

Brief summary: The goal of this study is to determine the effectiveness and sustainability of a community-participatory hydration intervention over 3 years within a district that has newly installed hydration stations and is operating under a policy designed to enhance heathy hydration practices and promote equitable access to drinking water.

Detailed description: The goal of this study is to determine the effectiveness of a hydration intervention on hydration station usage (primary outcome), Body Mass Index z-scores (zBMI) and dental caries (primary biomedical outcomes), and water bottle usage, beverage selection and intake, and academic outcomes (secondary outcomes).

Eligibility criteria: Inclusion Criteria:

* Lunchroom observations: All students (K-5th \[Pre-Kindergarten if applicable\]) who eat lunch in the cafeteria on assessment days are eligible
* BMI and dental caries assessments: 1) student enrolls in study while in 3rd grade (followed through 5th g)
* Student surveys: Students in 4th-5th grade are eligible to complete surveys assessing beverage intake and perceptions of hydration practices within their school district.
* Staff surveys: All staff in the target schools will be eligible to complete the Personnel Survey.

Exclusion Criteria:

* Lunchroom observations: None.
* BMI and dental caries assessments: Students are ineligible if they are unable to complete assessments due to developmental or physical reasons, 2) planning to move in the study duration
* Student surveys: None.
* Staff surveys: None.

Primary outcomes:
measure: Water Station Usage
timeFrame: Years 1-3
measure: Dental Caries Status
timeFrame: up to 3 years
measure: Body Mass Index (BMI)
timeFrame: up to 3 years
Secondary outcomes:
measure: Water Bottle Usage at Lunch
timeFrame: up to 3 years
measure: Beverage Selection at Lunch
timeFrame: up to 3 years
measure: Academics
timeFrame: up to 3 years
measure: Beverage Intake
timeFrame: up to 3 years
measure: Water Source Assessment
timeFrame: up to 3 years
measure: School Personnel Knowledge
timeFrame: up to 3 years
measure: School Environment
timeFrame: up to 3 years
measure: Beverage Sales
timeFrame: up to 3 years
measure: National School Lunch Program (NSLP) Participation
timeFrame: up to 3 years
Other outcomes:
measure: Demographics
timeFrame: up to 3 years
measure: Attendance
timeFrame: Pre-intervention, Month 1, Month 2, Month 3
measure: Implementation of Intervention
timeFrame: through study completion, an average of each year
measure: Perspectives of the intervention
timeFrame: 4 months and 16 months post-intervention
Locations:
city: Henrico
country: United States
facility: Children's Hospital of Richmond at VCU Healthy Lifestyles Center
state: Virginia
Study officials:
References: