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NCT Number: NCT06714929

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

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.

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Key information

Conditions

Dental Caries Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity Prevention Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Henrico, Virginia, 23229, United States

Location status: Recruiting

Location contact

Melanie K Bean, PhD

CONTACT

[email protected]

(804) 527-4765

Melanie K Bean, PhD

PRINCIPAL_INVESTIGATOR

Sarah M Farthing, MS

CONTACT

[email protected]

804-527-4756

Tegwyn H Brickhouse, DDS

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Water Station Usage

    Time frame: Years 1-3

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

  2. Dental Caries Status

    Time frame: up to 3 years

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

  3. Body Mass Index (BMI)

    Time frame: up to 3 years

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

Secondary outcomes

  1. Water Bottle Usage at Lunch

    Time frame: up to 3 years

    % of students with water bottles in school

  2. Beverage Selection at Lunch

    Time frame: up to 3 years

    % of each beverage selected (water, white milk, flavored milk, 100% juice, soda, sports-drink, other sugar-sweetened beverage (SSB), other non-SSB, unknown)

  3. Academics

    Time frame: up to 3 years

    Standards of Learning scores ranging from 0-600 with higher scores representing higher academic proficiency.

  4. Beverage Intake

    Time frame: up to 3 years

    modified beverage intake questionnaire (BEVQ; 12-item) will assess frequency and amount of SSB and water consumption to determine average daily consumption in fl oz and kcal over the past month for each item and across categories: water, total SSBs (sweetened juice and drinks, regular carbonated beverages, sweet tea, sweetened coffee, energy drinks), milk, 100% juice.

  5. Water Source Assessment

    Time frame: up to 3 years

    Video of water sources and then coded by trained raters. Coding for: cleanliness, wear, availability of drinking vessels, filter status, obstructions, signage, trash, and water flow

  6. School Personnel Knowledge

    Time frame: up to 3 years

    Measured via surveys: perceptions of water bottle use and hydration in school, knowledge and beliefs about hydration, personnel hydration practices, and awareness of and adherence to existing hydration policy

  7. School Environment

    Time frame: up to 3 years

    Measured via semi-structured interview: assessing water and SSB-related access, policies and practices in their school

  8. Beverage Sales

    Time frame: up to 3 years

    We will evaluate purchases of white milk, sugar-sweetened milk, 100% juice, and other beverages.

  9. National School Lunch Program (NSLP) Participation

    Time frame: up to 3 years

    Daily and monthly NSLP participation rates will be obtained

Other outcomes

  1. Demographics

    Time frame: up to 3 years

    School-level sex, race, ethnicity and enrollment will be obtained from the Department of Education

  2. Attendance

    Time frame: Pre-intervention, Month 1, Month 2, Month 3

    Attendance by grade on observation days will be obtained (to determine participation rates)

  3. Implementation of Intervention

    Time frame: through study completion, an average of each year

    Fidelity checklists, surveys, logs of implementation components

  4. Perspectives of the intervention

    Time frame: 4 months and 16 months post-intervention

    Semi-structured interviews with key stakeholders to assess barriers and facilitators to intervention implementation and sustainability.

Study contacts

Contact information is provided by the study sponsor or research team.

Melanie K Bean, PhD

CONTACT

[email protected]

804-527-4765

Sarah Farthing, MS

CONTACT

[email protected]

804-527-4756

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

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

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Dec 4, 2024
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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