School Water Access, Food and Beverage Intake, and Obesity
The Impact of the School Water Access on Child Food and Beverage Intake and Obesity
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Anisha Patel, MD,MSPH
- Phone Number: 650-497-1181
Study Locations
-
-
California
-
Stanford, California, United States, 94305-5119
- Stanford
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 4th grade students, students in 4th grade combination classes who speak English or Spanish and who don't have health conditions that preclude intake of water
- School administrators and food service directors at study schools
Exclusion Criteria:
- Students not in the 4th grade or 4th grade combination classes
- Students who do not speak English or Spanish
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Water Access and Promotion - Students
Intervention group will receive installation of water stations in high traffic areas, schoolwide promotion, and 4th graders will receive a curricula focused on increasing intake of water.
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The Water First intervention consists of increased access to safe and appealing drinking water in schools, school-wide promotion to increase students' intake of water, and education directed to 4th grade students and their families to increase intake of water.
|
|
No Intervention: Control - Students
Participants do not receive an intervention
|
|
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No Intervention: School Personnel
School administrators and food service managers provide information on school policies and procedures.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 85%
Time Frame: Baseline, 7-months, and 15-months after the start of the study.
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Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual.
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Baseline, 7-months, and 15-months after the start of the study.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 95%. Yes or No.
Time Frame: Baseline, 7-months, and 15-months after the start of the study.
|
Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual.
|
Baseline, 7-months, and 15-months after the start of the study.
|
|
BMI Percentile,Mean(SD)
Time Frame: Baseline, 7-months, and 15-months after the start of the study.
|
Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual.
|
Baseline, 7-months, and 15-months after the start of the study.
|
|
BMI, Mean (SD)
Time Frame: Baseline, 7-months, and 15-months after the start of the study.
|
Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual.
|
Baseline, 7-months, and 15-months after the start of the study.
|
|
BMI Z-score, Mean (SD)
Time Frame: Baseline, 7-months, and 15-months after the start of the study.
|
Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual.
BMI z-scores (or standard deviation scores) are used in anthropometry to quantify a measurement's distance from the mean.
The measurement is obtained using the sex, age, weight and height of the participants.
The z-score is based on United States Centers for Disease Control and Prevention growth references for children.
A z-score of 0 reflects the 50th percentile based on the reference growth charts.
For example, a z-score of 1.5 indicates a child is 1.5 standard deviations above the average value, whereas a z-score of -1.5 means a child is 1.5 standard deviations below the average value.
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Baseline, 7-months, and 15-months after the start of the study.
|
|
Caloric Intake
Time Frame: Baseline and 7-months after the start of the study
|
Food and beverage diaries will be used to calculate daily caloric intake from foods and beverages.
|
Baseline and 7-months after the start of the study
|
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Water Intake - Grams Consumed
Time Frame: Baseline and 7-months
|
Food and beverage diaries will be used to calculate daily water intake.
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Baseline and 7-months
|
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Beverage Intake
Time Frame: Baseline, 7-months, and 15-months after the start of the study.
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Beverage intake frequency questionnaires will be used to calculate past-week frequency of beverages consumed (times per day).
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Baseline, 7-months, and 15-months after the start of the study.
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Water Intake
Time Frame: Baseline, 7-months, and 15-months after the start of the study.
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Direct observations of water consumed at lunchtime, 4th-grade physical education (PE) classes, and recess.
Researchers tallied the number of students using water sources and the student census in the area to estimate the proportion using stations or fountains.
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Baseline, 7-months, and 15-months after the start of the study.
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
School Policies and Practices
Time Frame: Baseline and 15-months after the start of the study
|
School administrators and food service director surveys of nutrition and physical activity policies and practices at schools
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Baseline and 15-months after the start of the study
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Anisha Patel, MD, MSPH, Stanford University
Publications and helpful links
General Publications
- Ezennia J, Schmidt LA, Ritchie LD, Blacker L, McCulloch CE, Patel AI. Water Security Experiences and Water Intake Among Elementary Students at Low-Income Schools: A Cross-Sectional Study. Acad Pediatr. 2023 Jan-Feb;23(1):68-75. doi: 10.1016/j.acap.2022.04.008. Epub 2022 May 7.
- Moreno GD, Schmidt LA, Ritchie LD, McCulloch CE, Cabana MD, Brindis CD, Green LW, Altman EA, Patel AI. A cluster-randomized controlled trial of an elementary school drinking water access and promotion intervention: Rationale, study design, and protocol. Contemp Clin Trials. 2021 Feb;101:106255. doi: 10.1016/j.cct.2020.106255. Epub 2020 Dec 25.
- Patel AI, Schmidt LA, McCulloch CE, Blacker LS, Cabana MD, Brindis CD, Ritchie LD. Effectiveness of a School Drinking Water Promotion and Access Program for Overweight Prevention. Pediatrics. 2023 Sep 1;152(3):e2022060021. doi: 10.1542/peds.2022-060021.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 1R01HL129288-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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