School Water Access, Food and Beverage Intake, and Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03181971
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : October 16, 2018
University of California Division of Agriculture and Natural Resources
University of California, San Francisco
Information provided by (Responsible Party):
Anisha I Patel, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Water First Not Applicable

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 9 and 15 months after the start of the intervention, researchers will measure differences in: 1) water intake (observations and measurements of water taken from water sources) 2) total caloric intake from foods and beverages (24-hour food and beverage diaries) and 3) overweight/obesity prevalence between students in intervention and control schools. 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  (Clinical Trial)
Estimated Enrollment : 1742 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of the School Water Access on Child Food and Beverage Intake and Obesity
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Water Access and Promotion
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.
Behavioral: Water First
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
Usual care.

Primary Outcome Measures :
  1. Change in BMI z-score [ Time Frame: Baseline, 9-months, and 15-months after the start of the study ]
    The aggregate BMI measure will be calculated using height and weight measurements.

Secondary Outcome Measures :
  1. Total caloric intake [ Time Frame: Baseline, 9-months, and 15-months after the start of the study ]
    Food and beverage diaries will be used to calculate total daily caloric intake.

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Exclusion Criteria:

  • Students not in the 4th grade or 4th grade combination classes
  • Students who do not speak English or Spanish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03181971

Contact: Anisha Patel, MD,MSPH 650-497-1181

United States, California
Stanford Recruiting
Stanford, California, United States, 94305-5119
Contact: Anisha Patel, MD, MSPH    650-497-1181   
Sponsors and Collaborators
Stanford University
University of California Division of Agriculture and Natural Resources
University of California, San Francisco
Principal Investigator: Anisha Patel, MD, MSPH Stanford University

Responsible Party: Anisha I Patel, Associate Professor, Stanford University Identifier: NCT03181971     History of Changes
Other Study ID Numbers: 1R01HL129288-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anisha I Patel, Stanford University:
sugar-sweetened beverages

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms