Menu
Recruiting NCT06714929

Advancing Water Security: A Community Participatory School-Based Hydration Intervention

No phase Interventional Dental Caries Obesity Prevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydration.
Who it may be relevant to
Registry conditions: Dental Caries, Obesity Prevention. Basic parameters: from 4 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Interventions

  • Behavioral Hydration
    Clusters of schools will sequentially be exposed to the intervention in a stepped-wedge fashion. The intervention is a 4-month community participatory school-based hydration intervention that includes provision of refillable water bottles in schools with hydration stations in addition to: 1) social marketing, 2) behavioral reinforcement, and 3) education and outreach.

Primary outcome measures

  • Water Station Usage [Time frame: Years 1-3]
  • Dental Caries Status [Time frame: up to 3 years]
  • Body Mass Index (BMI) [Time frame: up to 3 years]
Secondary outcome measures (9)
  • Water Bottle Usage at Lunch [Time frame: up to 3 years]
  • Beverage Selection at Lunch [Time frame: up to 3 years]
  • Academics [Time frame: up to 3 years]
  • Beverage Intake [Time frame: up to 3 years]
  • Water Source Assessment [Time frame: up to 3 years]
  • School Personnel Knowledge [Time frame: up to 3 years]
  • School Environment [Time frame: up to 3 years]
  • Beverage Sales [Time frame: up to 3 years]
  • National School Lunch Program (NSLP) Participation [Time frame: up to 3 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Children's Hospital of Richmond at VCU Healthy Lifestyles Center — Henrico

Identifiers

NCT: NCT06714929 · HM20028646 · R01HD114792

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗