Clinical trial NCT03181971: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: water
sugar-sweetened beverages
schools
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: University of California
First posted: 2017-06-09
Enrollment: 1861
Sex: ALL
Minimum age (years): 9
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 85%
timeFrame: Baseline, 7-months, and 15-months after the start of the study.
Secondary outcomes:
measure: Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 95%. Yes or No.
timeFrame: Baseline, 7-months, and 15-months after the start of the study.
measure: BMI Percentile,Mean(SD)
timeFrame: Baseline, 7-months, and 15-months after the start of the study.
measure: BMI, Mean (SD)
timeFrame: Baseline, 7-months, and 15-months after the start of the study.
measure: BMI Z-score, Mean (SD)
timeFrame: Baseline, 7-months, and 15-months after the start of the study.
measure: Caloric Intake
timeFrame: Baseline and 7-months after the start of the study
measure: Water Intake - Grams Consumed
timeFrame: Baseline and 7-months
measure: Beverage Intake
timeFrame: Baseline, 7-months, and 15-months after the start of the study.
measure: Water Intake
timeFrame: Baseline, 7-months, and 15-months after the start of the study.
Other outcomes:
measure: School Policies and Practices
timeFrame: Baseline and 15-months after the start of the study
Locations:
city: Stanford
country: United States
facility: Stanford
state: California
Study officials:
affiliation: Stanford University
name: Anisha Patel, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.