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

NCT ID: NCT06714929

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

7200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-14

Study Completion Date

2028-05-31

Brief Summary

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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

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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).

Conditions

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Dental Caries Obesity Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control

Assessment only

Group Type NO_INTERVENTION

No interventions assigned to this group

Hydration Intervention

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.

Group Type EXPERIMENTAL

Hydration

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Henrico, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah Farthing, MS

Role: CONTACT

804-527-4756

Melanie K Bean, PhD

Role: CONTACT

804-527-4765

Facility Contacts

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Sarah M Farthing, MS

Role: primary

804-527-4756

Melanie K Bean, PhD

Role: backup

(804) 527-4765

Other Identifiers

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R01HD114792

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20028646

Identifier Type: -

Identifier Source: org_study_id

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