- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03181971
School Water Access, Food and Beverage Intake, and Obesity
June 3, 2024 updated by: Anisha I Patel, Stanford University
The Impact of the School Water Access on Child Food and Beverage Intake and Obesity
It is widely argued that the promotion of water consumption, as an alternative to sugar-sweetened beverages, can assist in childhood obesity prevention efforts.
Yet no studies have tested this argument in real world schools where flavored milk or juices are available.
This trial will fill gaps by examining how promoting fresh water intake-both in schools that do and do not provide access to caloric beverages -impacts children's consumption of food and beverages both during and outside of school, and obesity.
Study Overview
Detailed Description
Maintaining a healthy weight is important for young children because childhood obesity is predictive of adult obesity and related chronic illness.
Intake of sugar-sweetened beverages (SSBs: sodas, flavored milks, fruit-flavored drinks, and other drinks with added sugar) is a major contributor to obesity.
This is particularly true for low income children who are more likely to drink SSBs and to be obese.
Children spend substantial time in schools where they consume up to 50% of daily calories, including those from SSBs.
Consequently, many obesity prevention efforts have targeted reductions in SSB intake in schools.
Recently, scientific authorities have also recommended that schools improve the availability of potable and free drinking water - a healthy alternative to SSBs - as a low-cost and feasible obesity prevention strategy.
Emerging policies also mandate water access in schools; but implementation is poor.
Although the 2010 Healthy, Hunger-Free Kids Act requires schools participating in federal meal programs to provide free potable water where meals are served, 25% of US schools still fail to do so.
And even in schools that offer free water, drinking fountains may be avoided due to concerns about cleanliness or sub-standard water quality.
While promotion of drinking water intake in schools is a plausible obesity prevention strategy, no large studies have systematically examined how this tactic can change children's overall dietary patterns and obesity rates in schools that offer SSBs and juices.
This study's central hypothesis is that in elementary schools, increased access to fresh water and rigorous promotion of its consumption will reduce student intake of caloric beverages, thereby leading to lower rates of obesity.
This hypothesis will be tested through a cluster-randomized trial in 26 low-income elementary schools in the San Francisco Bay Area, in which 13 schools will receive a water promotion intervention and 13 schools will serve as controls.
The intervention, based on Social Cognitive Theory and the PRECEDE-PROCEED Model and cultivated in the investigators' prior developmental studies, promotes water consumption by: 1) installing lead-free water stations in cafeterias, physical activity spaces and high-traffic common areas, 2) providing cups and reusable water bottles for students, and 3) conducting a 6-month health education campaign that includes a kick-off play, class lessons, family homework activities, signage, and rewards.
From baseline to 7 and 15 months after the start of the intervention, researchers measure differences in: 1) water intake (observations and measurements of water taken from water sources) 2) water and SSB intake via beverage frequency questionnaires and 3) overweight/obesity prevalence between students in intervention and control schools.
Total caloric intake from foods and beverages (24-hour food and beverage diaries) are measured at baseline and 7 months only due to budget cuts and their resource intensiveness.
If the proposed school water intervention is effective, school officials will have a feasible and low-cost obesity prevention tool.
US schools will soon be federally mandated to reevaluate their wellness policies in order to implement new food and beverage regulations.
This study presents a timely opportunity to provide leaders with an evidence-based strategy for improving student nutrition and health.
Study Type
Interventional
Enrollment (Actual)
1861
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Stanford, California, United States, 94305-5119
- Stanford
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 12 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / 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.
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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
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.
|
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.
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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.
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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.
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Caloric Intake
Time Frame: Baseline and 7-months after the start of the study
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Food and beverage diaries will be used to calculate daily caloric intake from foods and beverages.
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Baseline and 7-months after the start of the study
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Water Intake - Grams Consumed
Time Frame: Baseline and 7-months
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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.
|
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
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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
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anisha Patel, MD, MSPH, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2016
Primary Completion (Actual)
May 25, 2022
Study Completion (Actual)
May 27, 2022
Study Registration Dates
First Submitted
June 3, 2017
First Submitted That Met QC Criteria
June 8, 2017
First Posted (Actual)
June 9, 2017
Study Record Updates
Last Update Posted (Actual)
June 27, 2024
Last Update Submitted That Met QC Criteria
June 3, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01HL129288-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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