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School Water Access, Food and Beverage Intake, and Obesity

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ClinicalTrials.gov Identifier: NCT03181971
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : October 29, 2021
Sponsor:
Collaborators:
University of California, San Francisco
University of California
Information provided by (Responsible Party):
Anisha I Patel, Stanford University

Tracking Information
First Submitted Date  ICMJE June 3, 2017
First Posted Date  ICMJE June 9, 2017
Last Update Posted Date October 29, 2021
Actual Study Start Date  ICMJE August 1, 2016
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2021)
Change in BMI z-score [ Time Frame: Baseline, 9-months, and 15-months after the start of the study. Due to the COVID-19 pandemic and study school closures, it is unclear if the study will be powered to detect changes in this primary outcome. ]
The aggregate BMI measure will be calculated using height and weight measurements.
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE School Water Access, Food and Beverage Intake, and Obesity
Official Title  ICMJE The Impact of the School Water Access on Child Food and Beverage Intake and Obesity
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Water First
  • No Intervention: Control
    Usual care.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 8, 2017)
1742
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2022
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anisha Patel, MD,MSPH 650-497-1181
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03181971
Other Study ID Numbers  ICMJE 1R01HL129288-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anisha I Patel, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE
  • University of California, San Francisco
  • University of California
Investigators  ICMJE
Principal Investigator: Anisha Patel, MD, MSPH Stanford University
PRS Account Stanford University
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP