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School Water Access, Food and Beverage Intake, and Obesity

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water First
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring water, sugar-sweetened beverages, schools

Eligibility Criteria

9 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Water Access and Promotion

Control

Arm Description

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.

Usual care.

Outcomes

Primary Outcome Measures

Proportion of students in the schools who have overweight or obese (i.e., have an age- and sex-adjusted BMI% greater than or equal to 85%).
In order to obtain the % of students who are overweight or obese, trained research staff will measure students' heights and weights using calibrated scales and stadiometers as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual. Using a statistical program developed by the Centers for Disease Control and Prevention, we will use these measurements along with date of birth and sex obtained from student surveys to calculate students' age and sex adjusted BMI%.

Secondary Outcome Measures

Caloric intake
Food and beverage diaries will be used to calculate daily caloric intake from foods and beverages.
Beverage intake
Beverage intake frequency questionnaires will be used to calculate past-week frequency of beverages consumed.
Water intake
Direct observations of water consumed at lunchtime, 4th-grade physical education classes, and recess.

Full Information

First Posted
June 3, 2017
Last Updated
September 11, 2023
Sponsor
Stanford University
Collaborators
University of California, San Francisco, University of California
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1. Study Identification

Unique Protocol Identification Number
NCT03181971
Brief Title
School Water Access, Food and Beverage Intake, and Obesity
Official Title
The Impact of the School Water Access on Child Food and Beverage Intake and Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
May 25, 2022 (Actual)
Study Completion Date
May 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
University of California, San Francisco, University of California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
water, sugar-sweetened beverages, schools

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1861 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water Access and Promotion
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care.
Intervention Type
Behavioral
Intervention Name(s)
Water First
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of students in the schools who have overweight or obese (i.e., have an age- and sex-adjusted BMI% greater than or equal to 85%).
Description
In order to obtain the % of students who are overweight or obese, trained research staff will measure students' heights and weights using calibrated scales and stadiometers as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual. Using a statistical program developed by the Centers for Disease Control and Prevention, we will use these measurements along with date of birth and sex obtained from student surveys to calculate students' age and sex adjusted BMI%.
Time Frame
Baseline, 7-months, and 15-months after the start of the study.
Secondary Outcome Measure Information:
Title
Caloric intake
Description
Food and beverage diaries will be used to calculate daily caloric intake from foods and beverages.
Time Frame
Baseline and 7-months after the start of the study
Title
Beverage intake
Description
Beverage intake frequency questionnaires will be used to calculate past-week frequency of beverages consumed.
Time Frame
Baseline, 7-months, and 15-months after the start of the study.
Title
Water intake
Description
Direct observations of water consumed at lunchtime, 4th-grade physical education classes, and recess.
Time Frame
Baseline, 7-months, and 15-months after the start of the study.
Other Pre-specified Outcome Measures:
Title
School Policies and Practices
Description
School administrators and food service director surveys of nutrition and physical activity policies and practices at schools
Time Frame
Baseline and 15-months after the start of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anisha Patel, MD, MSPH
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35537674
Citation
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.
Results Reference
background
PubMed Identifier
33370616
Citation
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.
Results Reference
background
PubMed Identifier
37545466
Citation
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.
Results Reference
result

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School Water Access, Food and Beverage Intake, and Obesity

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