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NCT03181971

School Water Access, Food and Beverage Intake, and Obesity

Completed NA Results posted Last updated 27 June 2024
What this trial tests

NA trial testing Water First in Obesity in 1,861 participants. Completed in 27 May 2022.

Timeline
1 August 2016
Primary endpoint
25 May 2022
27 May 2022

Quick facts

Lead sponsorStanford University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment1,861
Start date1 August 2016
Primary completion25 May 2022
Estimated completion27 May 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Stanford University

Who can join

Adults 9 to 100, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 85% Primary · Baseline, 7-months, and 15-months after the start of the study.

Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual.

Baseline
GroupValue95% CI
Water Access and Promotion - Students335
Control - Students273
Month 7
GroupValue95% CI
Water Access and Promotion - Students315
Control - Students263
Month 15
GroupValue95% CI
Water Access and Promotion - Students274
Control - Students262
Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 95%. Yes or No. Secondary · Baseline, 7-months, and 15-months after the start of the study.

Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual.

Baseline
GroupValue95% CI
Water Access and Promotion - Students222
Control - Students165
Month 7
GroupValue95% CI
Water Access and Promotion - Students202
Control - Students159
Month 15
GroupValue95% CI
Water Access and Promotion - Students179
Control - Students144
BMI Percentile,Mean(SD) Secondary · Baseline, 7-months, and 15-months after the start of the study.

Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual.

Baseline
GroupValue95% CI
Water Access and Promotion - Students73.2± 28.1
Control - Students71.9± 28.7
Month 7
GroupValue95% CI
Water Access and Promotion - Students73.7± 27.1
Control - Students71.8± 28.4
Month 15
GroupValue95% CI
Water Access and Promotion - Students73.5± 28.0
Control - Students72.9± 28.5
BMI, Mean (SD) Secondary · Baseline, 7-months, and 15-months after the start of the study.

Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual.

Baseline
GroupValue95% CI
Water Access and Promotion - Students20.4± 4.6
Control - Students20.1± 4.6
Month 7
GroupValue95% CI
Water Access and Promotion - Students20.9± 4.7
Control - Students20.5± 4.7
Month 15
GroupValue95% CI
Water Access and Promotion - Students21.4± 5.1
Control - Students21.2± 4.9
BMI Z-score, Mean (SD) Secondary · Baseline, 7-months, and 15-months after the start of the study.

Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual. BMI z-scores (or standard deviation scores) are used in anthropometry to quantify a measurement's distance from the mean. The measurement is obtained using the sex, age, weight and height of the participants. The z-score is based on United States Centers for Disease Control and Prevention growth references for children. A z-score of 0 reflects the 50th percentile based on the reference growth charts. For example, a z-score of 1.5

Baseline
GroupValue95% CI
Water Access and Promotion - Students0.9± 1.1
Control - Students0.8± 1.1
Month 7
GroupValue95% CI
Water Access and Promotion - Students0.9± 1.1
Control - Students0.8± 1.1
Month 15
GroupValue95% CI
Water Access and Promotion - Students0.9± 1.1
Control - Students0.9± 1.1
Caloric Intake Secondary · Baseline and 7-months after the start of the study

Food and beverage diaries will be used to calculate daily caloric intake from foods and beverages.

Total - baseline
GroupValue95% CI
Water Access and Promotion - Students1636± 796
Control - Students1699± 727
Total - month 7
GroupValue95% CI
Water Access and Promotion - Students1610± 805
Control - Students1676± 782
Food - baseline
GroupValue95% CI
Water Access and Promotion - Students1371± 705
Control - Students1434± 654
Food - month 7
GroupValue95% CI
Water Access and Promotion - Students1380± 727
Control - Students1425± 696
Beverage - baseline
GroupValue95% CI
Water Access and Promotion - Students265± 214
Control - Students265± 212
Beverage - month 7
GroupValue95% CI
Water Access and Promotion - Students229± 227
Control - Students251± 231
Sugar-sweetened beverage (SSB) - baseline
GroupValue95% CI
Water Access and Promotion - Students223± 205
Control - Students223± 204
SSB - month 7
GroupValue95% CI
Water Access and Promotion - Students190± 199
Control - Students214± 223
Water Intake - Grams Consumed Secondary · Baseline and 7-months

Food and beverage diaries will be used to calculate daily water intake.

Baseline
GroupValue95% CI
Water Access and Promotion - Students414± 443
Control - Students454± 441
Month 7
GroupValue95% CI
Water Access and Promotion - Students462± 576
Control - Students441± 472
Beverage Intake Secondary · Baseline, 7-months, and 15-months after the start of the study.

Beverage intake frequency questionnaires will be used to calculate past-week frequency of beverages consumed (times per day).

Water - baseline
GroupValue95% CI
Water Access and Promotion - Students6.1± 4.3
Control - Students5.7± 4.2
Water - month 7
GroupValue95% CI
Water Access and Promotion - Students7.1± 5.2
Control - Students5.2± 3.9
Water - month 15
GroupValue95% CI
Water Access and Promotion - Students6.2± 4.7
Control - Students4.8± 3.8
SSB - baseline
GroupValue95% CI
Water Access and Promotion - Students3.5± 4.2
Control - Students3.5± 4.2
SSB - month 7
GroupValue95% CI
Water Access and Promotion - Students2.4± 3.5
Control - Students2.8± 3.7
SSB - month 15
GroupValue95% CI
Water Access and Promotion - Students2.1± 2.8
Control - Students2.2± 2.9
Juice - baseline
GroupValue95% CI
Water Access and Promotion - Students0.8± 1.1
Control - Students0.8± 1.1
Juice - month 7
GroupValue95% CI
Water Access and Promotion - Students0.6± 1.0
Control - Students0.6± 0.8
Water Intake Secondary · Baseline, 7-months, and 15-months after the start of the study.

Direct observations of water consumed at lunchtime, 4th-grade physical education (PE) classes, and recess. Researchers tallied the number of students using water sources and the student census in the area to estimate the proportion using stations or fountains.

Lunch - baseline
GroupValue95% CI
Water Access and Promotion - Students3.5± 6.1
Control - Students3.7± 6.1
Lunch - month 7
GroupValue95% CI
Water Access and Promotion - Students38.3± 15.9
Control - Students3.6± 4.7
Lunch - month 15
GroupValue95% CI
Water Access and Promotion - Students9.2± 7.7
Control - Students3.2± 3.1
Recess - baseline
GroupValue95% CI
Water Access and Promotion - Students6.5± 3.4
Control - Students6.1± 4.5
Recess - month 7
GroupValue95% CI
Water Access and Promotion - Students29.3± 36.5
Control - Students6.6± 4.1
Recess - month 15
GroupValue95% CI
Water Access and Promotion - Students8.8± 3.1
Control - Students3.3± 3.0
PE class - baseline
GroupValue95% CI
Water Access and Promotion - Students66.6± 87.8
Control - Students47.4± 32.2
PE class - month 7
GroupValue95% CI
Water Access and Promotion - Students89.6± 58.7
Control - Students53.2± 65.6

Adverse events — posted to ClinicalTrials.gov

Time frame: 15 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Water Access and Promotion - Students
Serious: 1/680 (0%)
Deaths: 1/680
Water Access and Promotion - School Personnel
Serious: 0/10 (0%)
Deaths: 0/10
Control - Students
Serious: 0/582 (0%)
Deaths: 0/582
Control - School Personnel
Serious: 0/12 (0%)
Deaths: 0/12
Food Service Directors
Serious: 0/13 (0%)
Deaths: 0/13

Serious adverse events (1 terms)

ReactionSystemWater Access and Promotion…Water Access and Promotion…Control - StudentsControl - School PersonnelFood Service Directors
DeathGeneral disorders

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT03181971 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health.
    von Philipsborn P, Stratil JM, Burns J, Busert LK, et al · · 2019 · cited 177× · PMID 31194900 · DOI 10.1002/14651858.cd012292.pub2
  2. Interventions to prevent obesity in children aged 5 to 11 years old.
    Spiga F, Davies AL, Tomlinson E, Moore TH, et al · · 2024 · cited 40× · PMID 38763517 · DOI 10.1002/14651858.cd015328.pub2
  3. Effectiveness of a School Drinking Water Promotion and Access Program for Overweight Prevention.
    Patel AI, Schmidt LA, McCulloch CE, Blacker LS, et al · · 2023 · cited 12× · PMID 37545466 · DOI 10.1542/peds.2022-060021
  4. A cluster-randomized controlled trial of an elementary school drinking water access and promotion intervention: Rationale, study design, and protocol.
    Moreno GD, Schmidt LA, Ritchie LD, McCulloch CE, et al · · 2021 · cited 8× · PMID 33370616 · DOI 10.1016/j.cct.2020.106255
  5. Water Promotion for Overweight Prevention in Schoolchildren: For Whom Does It Work Best? - Results of a Randomized Controlled Trial.
    Richard V, Ryu K, Peralta Y, Pedroza-Tobias A, et al · · 2026 · PMID 41167508 · DOI 10.1016/j.amepre.2025.108175

Verify or expand the search:

Other recruiting trials for Obesity

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03181971.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing