School Water Access, Food and Beverage Intake, and Obesity

NCT03181971 | Completed Results DMC

• 1 other identifier: 1R01HL129288-01A1
• Study Type: interventional
• Target: 1,861
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

water; sugar-sweetened beverages; schools

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 85%

  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.

Secondary Outcomes (8)

• Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 95%. Yes or No.

  Baseline, 7-months, and 15-months after the start of the study.

• BMI Percentile,Mean(SD)

  Baseline, 7-months, and 15-months after the start of the study.

• BMI, Mean (SD)

  Baseline, 7-months, and 15-months after the start of the study.

• BMI Z-score, Mean (SD)

  Baseline, 7-months, and 15-months after the start of the study.

• Caloric Intake

  Baseline and 7-months after the start of the study

Other Outcomes (1)

• School Policies and Practices

  Baseline and 15-months after the start of the study

Study Arms (3)

Water Access and Promotion - Students

EXPERIMENTAL

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

Control - Students

NO INTERVENTION

Participants do not receive an intervention

School Personnel

NO INTERVENTION

School administrators and food service managers provide information on school policies and procedures.

Interventions

Water First BEHAVIORAL

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.

Water Access and Promotion - Students

Eligibility Criteria

• Age: 9 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• th 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• University of California, San Francisco: collaborator
• University of California: collaborator

Study Sites (1)

Stanford

Stanford, California, 94305-5119, United States

Location

Related Publications (3)

• 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.

  PMID: 35537674 BACKGROUND

• 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.

  PMID: 33370616 BACKGROUND

• 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.

  PMID: 37545466 RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anisha Patel, MD
• Organization: Stanford University

anipatel@stanford.edu

(650) 497-1181

Study Officials

• Anisha Patel, MD, MSPH

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2017
• First Posted: June 9, 2017
• Study Start: August 1, 2016
• Primary Completion: May 25, 2022
• Study Completion: May 27, 2022
• Last Updated: June 27, 2024
• Results First Posted: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)