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

ConditionsDental Caries Obesity Prevention

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age4+

SponsorVirginia Commonwealth University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

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.

Treatment groups

7,200 Participants

are divided into 2 treatment groups

Group A: ControlNo intervention 0 interventions

Group B: Hydration InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Water Station Usage

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

Time frame

Years 1-3

Dental Caries Status

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

Time frame

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

Time frame

up to 3 years

Secondary outcomes

Water Bottle Usage at Lunch

% of students with water bottles in school

Time frame

up to 3 years

Beverage Selection at Lunch

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

Time frame

up to 3 years

Academics

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

Time frame

up to 3 years

Beverage Intake

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.

Time frame

up to 3 years

Other outcomes

Demographics

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

Time frame

up to 3 years

Attendance

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

Time frame

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

Implementation of Intervention

Fidelity checklists, surveys, logs of implementation components

Time frame

through study completion, an average of each year

Perspectives of the intervention

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

Time frame

4 months and 16 months post-intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Virginia Commonwealth University

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov

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