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

NCT06714929 | Recruiting

• 2 other identifiers: HM20028646R01HD114792
• Study Type: interventional
• Target: 7,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Obesity Prevention

Keywords

hydration; water; sugar-sweetened beverages; dental caries; overweight and obesity

Outcome Measures

Primary Outcomes (3)

• Water Station Usage

  Ounces of water per student per day measured by hydration station flow meters.

  Years 1-3

• Dental Caries Status

  Tooth decay or cavities will be measured using a modified International Caries Detection and Assessment System (ICDAS)

  up to 3 years

• Body Mass Index (BMI)

  NHANES Anthropometry methods used to measure height and weight. Age and sex-specific BMIz-score and BMI percentile will be calculated using Epi Info

  up to 3 years

Secondary Outcomes (9)

• Water Bottle Usage at Lunch

  up to 3 years

• Beverage Selection at Lunch

  up to 3 years

• Academics

  up to 3 years

• Beverage Intake

  up to 3 years

• Water Source Assessment

  up to 3 years

Other Outcomes (4)

• Demographics

  up to 3 years

• Attendance

  Pre-intervention, Month 1, Month 2, Month 3

• Implementation of Intervention

  through study completion, an average of each year

Study Arms (2)

Control

NO INTERVENTION

Assessment only

Hydration Intervention

EXPERIMENTAL

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.

Behavioral: Hydration

Interventions

Hydration 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.

Hydration Intervention

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Henrico, Virginia, 23229, United States

RECRUITING

MeSH Terms

Conditions

Dental Caries; Overweight; Obesity

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sarah Farthing, MS

CONTACT

804-527-4756; sarah.malone@vcuhealth.org

Melanie K Bean, PhD

CONTACT

804-527-4765; melanie.bean@vcuhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: December 4, 2024
• Study Start: August 14, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Final submission and release of the study data will occur no later than the time of an associated publication or end of the performance period, whichever comes first. Study data deposited in DASH are available to the research community in perpetuity.
• Access Criteria: Public Use Data: All deidentified study data will be made available as public use data to the research community via DASH. Sharing will occur in accordance with the participant consent and Virginia Commonwealth University (VCU) Institutional Review Board approval. Users of the public use data must register with DASH and agree to the Terms of Use, which are designed to protect study participants by limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, and requiring immediate reporting of any disclosure of study participant identity. Data users also agree not to share or redistribute any data downloads. Datasets in DASH will be findable and identifiable through a study digital object identifier (DOI) assigned by DASH.

Locations

US (1)