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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD114792 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Water Bottle Usage at Lunch | % of students with water bottles in school | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Demographics | School-level sex, race, ethnicity and enrollment will be obtained from the Department of Education | up to 3 years |
| Attendance | Attendance by grade on observation days will be obtained (to determine participation rates) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Farthing, MS | Contact | 804-527-4756 | sarah.malone@vcuhealth.org | |
| Melanie K Bean, PhD | Contact | 804-527-4765 | melanie.bean@vcuhealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Richmond at VCU Healthy Lifestyles Center | Recruiting | Henrico | Virginia | 23229 | United States |
The following research data will be generated from this study: 1) lunchroom observations (beverage selection and water bottle use); 2) cafeteria sales data; 3) hydration station usage; 4) academic data (Standards of Learning scores, attendance); and 4) survey data. Student survey data include demographics, beverage intake, and intervention perceptions. Staff survey data includes hydration policies and practices and intervention perceptions. Longitudinal assessments of anthropometrics (serial height and weight measurements) and dental caries will be available from a subset of students (n=406). A subset of individuals will also complete interviews (n=80) regarding intervention implementation and sustainability. Any potentially identifying information (e.g., of individuals, schools, or the district) will be removed from these data prior to uploading them to the NICHD Data and Specimen Hub.
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.
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.
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D044343 | Overnutrition |
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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.
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| up to 3 years |
| Academics | Standards of Learning scores ranging from 0-600 with higher scores representing higher academic proficiency. | 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. | up to 3 years |
| Water Source Assessment | 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 | up to 3 years |
| School Personnel Knowledge | 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 | up to 3 years |
| School Environment | Measured via semi-structured interview: assessing water and SSB-related access, policies and practices in their school | up to 3 years |
| Beverage Sales | We will evaluate purchases of white milk, sugar-sweetened milk, 100% juice, and other beverages. | up to 3 years |
| National School Lunch Program (NSLP) Participation | Daily and monthly NSLP participation rates will be obtained | up to 3 years |
| Pre-intervention, Month 1, Month 2, Month 3 |
| Implementation of Intervention | Fidelity checklists, surveys, logs of implementation components | 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. | 4 months and 16 months post-intervention |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |