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CompletedNCT03181971Updated Jun 27, 2024Results posted

School Water Access, Food and Beverage Intake, and Obesity

An interventional study of Water First in Obesity, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 9 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-06-27.

Sponsored by Stanford University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Aug 2016, registered Jun 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
1,861
Allocation
Randomized
Ages
9 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity

Browse trials for

Keywords

  • water
  • sugar-sweetened beverages
  • schools
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 1,861 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Students not in the 4th grade or 4th grade combination classes
  • Students who do not speak English or Spanish
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,861 participants (actual)

Study arms

  • Experimental
    Water Access and Promotion - Students

    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

  • No intervention
    Control - Students

    Participants do not receive an intervention

  • No intervention
    School Personnel

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

Interventions

  • BehavioralWater 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.

06

What researchers measure

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.

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

Secondary outcomes

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

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

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

  2. BMI Percentile,Mean(SD)

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

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

  3. BMI, Mean (SD)

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

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

  4. BMI Z-score, Mean (SD)

    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 indicates a child is 1.5 standard deviations above the average value, whereas a z-score of -1.5 means a child is 1.5 standard deviations below the average value.

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

  5. Caloric Intake

    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

  6. Water Intake - Grams Consumed

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

    Time frame: Baseline and 7-months

  7. Beverage Intake

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

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

  8. Water Intake

    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.

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

Other outcomes

  1. School Policies and Practices

    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

07

Results

Posted Jun 27, 2024

Participant flow

Cluster-randomized trial: participants were enrolled from schools that were randomized to receive the intervention, or no intervention.

Participant flow — Overall Study
MilestoneWater Access and Promotion - StudentsControl - StudentsFood Service Directors
Started69059413
Students who started the study6805820
Adults who started study101213
Students that received allocated intervention / participated in allocated control6775720
Students who completed the study5485100
Adults who completed the study101213
Completed55852213
Not completed132720

Outcome measures

PrimaryNumber 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.

Time frame:
Baseline, 7-months, and 15-months after the start of the study.
Reported as:
Count of participants · Participants
Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 85%
ParticipantsWater Access and Promotion - StudentsControl - Students
Baseline335273
Month 7315263
Month 15274262
Statistical analysis
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = 0.68 · Odds ratio (or): 0.7 · 95% CI 0.2 to 2.9
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = 0.017 · Odds ratio (or): 0.1 · 95% CI 0.03 to 0.7
SecondaryNumber of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 95%. Yes or No.

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

Time frame:
Baseline, 7-months, and 15-months after the start of the study.
Reported as:
Count of participants · Participants
Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 95%. Yes or No.
ParticipantsWater Access and Promotion - StudentsControl - Students
Baseline222165
Month 7202159
Month 15179144
Statistical analysis
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .24 · Odds ratio (or): 0.4 · 95% CI 0.07 to 2.0
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .98 · Odds ratio (or): 1.0 · 95% CI 0.1 to 7.0
SecondaryBMI Percentile,Mean(SD)

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

Time frame:
Baseline, 7-months, and 15-months after the start of the study.
Reported as:
Mean · BMI-for-age/sex percentile
BMI Percentile,Mean(SD)
BMI-for-age/sex percentileWater Access and Promotion - StudentsControl - Students
Baseline73.2 ± 28.171.9 ± 28.7
Month 773.7 ± 27.171.8 ± 28.4
Month 1573.5 ± 28.072.9 ± 28.5
Statistical analysis
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = 0.57 · Adjusted mean difference: 0.2 · 95% CI -0.6 to 1.0
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .40 · Adjusted mean difference: -0.5 · 95% CI -1.5 to 0.6
SecondaryBMI, Mean (SD)

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

Time frame:
Baseline, 7-months, and 15-months after the start of the study.
Reported as:
Mean · kg/m^2
BMI, Mean (SD)
kg/m^2Water Access and Promotion - StudentsControl - Students
Baseline20.4 ± 4.620.1 ± 4.6
Month 720.9 ± 4.720.5 ± 4.7
Month 1521.4 ± 5.121.2 ± 4.9
Statistical analysis
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .46 · Adjusted mean difference: 0.04 · 95% CI -0.06 to 0.1
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .80 · Adjusted mean difference: -0.02 · 95% CI -0.2 to 0.1
SecondaryBMI Z-score, Mean (SD)

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 indicates a child is 1.5 standard deviations above the average value, whereas a z-score of -1.5 means a child is 1.5 standard deviations below the average value.

Time frame:
Baseline, 7-months, and 15-months after the start of the study.
Reported as:
Mean · z-score
BMI Z-score, Mean (SD)
z-scoreWater Access and Promotion - StudentsControl - Students
Baseline0.9 ± 1.10.8 ± 1.1
Month 70.9 ± 1.10.8 ± 1.1
Month 150.9 ± 1.10.9 ± 1.1
Statistical analysis
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .93 · Adjusted mean difference: 0.001 · 95% CI -0.03 to 0.03
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .36 · Adjusted mean difference: -0.02 · 95% CI -0.06 to 0.02
SecondaryCaloric Intake

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
Reported as:
Mean · kcal/day
Caloric Intake
kcal/dayWater Access and Promotion - StudentsControl - Students
Total - baseline1636 ± 7961699 ± 727
Total - month 71610 ± 8051676 ± 782
Food - baseline1371 ± 7051434 ± 654
Food - month 71380 ± 7271425 ± 696
Beverage - baseline265 ± 214265 ± 212
Beverage - month 7229 ± 227251 ± 231
Sugar-sweetened beverage (SSB) - baseline223 ± 205223 ± 204
SSB - month 7190 ± 199214 ± 223
Statistical analysis
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = 0.70 (Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time.) · Percent difference in change: 1.4 · 95% CI -5.3 to 8.5
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .35 (Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time.) · Percent difference in change: 3.7 · 95% CI -3.9 to 12.0
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .35 · Percent difference in change: -10.6 · 95% CI -29.2 to 8.8
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .18 · Percent difference in change: -17.5 · 95% CI -37.8 to 9.6
SecondaryWater Intake - Grams Consumed

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

Time frame:
Baseline and 7-months
Reported as:
Mean · grams/day
Water Intake - Grams Consumed
grams/dayWater Access and Promotion - StudentsControl - Students
Baseline414 ± 443454 ± 441
Month 7462 ± 576441 ± 472
Statistical analysis
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .59 (Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time.) · Percent difference in change: 9.1 · 95% CI -20.6 to 49.9
SecondaryBeverage Intake

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

Time frame:
Baseline, 7-months, and 15-months after the start of the study.
Reported as:
Mean · times per day
Beverage Intake
times per dayWater Access and Promotion - StudentsControl - Students
Water - baseline6.1 ± 4.35.7 ± 4.2
Water - month 77.1 ± 5.25.2 ± 3.9
Water - month 156.2 ± 4.74.8 ± 3.8
SSB - baseline3.5 ± 4.23.5 ± 4.2
SSB - month 72.4 ± 3.52.8 ± 3.7
SSB - month 152.1 ± 2.82.2 ± 2.9
Juice - baseline0.8 ± 1.10.8 ± 1.1
Juice - month 70.6 ± 1.00.6 ± 0.8
Juice - month 150.5 ± 1.00.5 ± 0.9
Flavored milk - baseline0.5 ± 0.90.5 ± 0.9
Flavored milk - month 70.4 ± 0.70.4 ± 0.8
Flavored milk - month 150.4 ± 0.80.4 ± 0.9
Plain milk - baseline1.2 ± 1.41.1 ± 1.3
Plain milk - month 71.2 ± 1.61.0 ± 1.2
Plain milk - month 151.1 ± 1.41.0 ± 1.2
Statistical analysis
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = <.001 · Percent difference in change: 23.2 · 95% CI 13.1 to 34.2
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .004 · Percent difference in change: 14.7 · 95% CI 4.5 to 25.9
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = 0.063 · Percent difference in change: -8.0 · 95% CI -15.7 to 0.4
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .56 · Percent difference in change: -2.8 · 95% CI -11.7 to 6.9
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .68 · Percent difference in change: 1.2 · 95% CI -4.3 to 7
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .66 · Percent difference in change: -1.4 · 95% CI -7.4 to 5
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = 0.079 · Percent difference in change: -4.0 · 95% CI -8.3 to 0.5
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .26 · Percent difference in change: -3.0 · 95% CI -8.0 to 2.3
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .20 · Percent difference in change: 4.4 · 95% CI -2.2 to 11.5
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .51 · Percent difference in change: 2.3 · 95% CI -4.4 to 9.6
SecondaryWater Intake

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.

Time frame:
Baseline, 7-months, and 15-months after the start of the study.
Reported as:
Mean · observations
Water Intake
observationsWater Access and Promotion - StudentsControl - Students
Lunch - baseline3.5 ± 6.13.7 ± 6.1
Lunch - month 738.3 ± 15.93.6 ± 4.7
Lunch - month 159.2 ± 7.73.2 ± 3.1
Recess - baseline6.5 ± 3.46.1 ± 4.5
Recess - month 729.3 ± 36.56.6 ± 4.1
Recess - month 158.8 ± 3.13.3 ± 3.0
PE class - baseline66.6 ± 87.847.4 ± 32.2
PE class - month 789.6 ± 58.753.2 ± 65.6
PE class - month 1595.0 ± 56.243.1 ± 38.1
Statistical analysis
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = <.001 · Percent difference in change: 31.3 · 95% CI 21.2 to 42.2
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .22 · Percent difference in change: 4.9 · 95% CI -3.0 to 13.5
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .02 · Percent difference in change: 17.0 · 95% CI 2.6 to 33.3
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .48 · Percent difference in change: 4.7 · 95% CI -8.0 to 19.2
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .14 · Percent difference in change: 34.6 · 95% CI -9.4 to 99.8
  • Water Access and Promotion - Students vs Control - Students · Mixed Models Analysis · p = .16 · Percent difference in change: 32.1 · 95% CI -11.0 to 96.2
Other pre-specifiedSchool Policies and Practices

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

Results for this outcome have not been posted.

Adverse events

Collected over 15 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Water Access and Promotion - Students1/680 (0.1%)1/680 (0.1%)0/680 (0%)
Water Access and Promotion - School Personnel0/10 (0%)0/10 (0%)0/10 (0%)
Control - Students0/582 (0%)0/582 (0%)0/582 (0%)
Control - School Personnel0/12 (0%)0/12 (0%)0/12 (0%)
Food Service Directors0/13 (0%)0/13 (0%)0/13 (0%)
Most frequent serious events
Most frequent serious events
EventWater Access and Promotion - StudentsWater Access and Promotion - School PersonnelControl - StudentsControl - School PersonnelFood Service Directors
DeathGeneral disorders1/6800/100/5820/120/13

Baseline characteristics

Student who received allocated intervention or participated in allocated control, and adult participants.

Age, Continuous
Age, Continuous(years)Water Access and Promotion - StudentsWater Access and Promotion - School PersonnelControl - StudentsControl - School PersonnelFood Service DirectorsTotal
Mean9.6 ± 0.4—9.6 ± 0.4——9.6 ± 0.4
Sex: Female, Male
Sex: Female, Male(Participants)Water Access and Promotion - StudentsWater Access and Promotion - School PersonnelControl - StudentsControl - School PersonnelFood Service DirectorsTotal
Female3185274613616
Male359529860668
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Water Access and Promotion - StudentsWater Access and Promotion - School PersonnelControl - StudentsControl - School PersonnelFood Service DirectorsTotal
Race and ethnicity, No (%) — Mexican American, Latino, Hispanic455—337——792
Race and ethnicity, No (%) — Non-Hispanic Asian80—94——174
Race and ethnicity, No (%) — Non-Hispanic Black26—25——51
Race and ethnicity, No (%) — Non-Hispanic White43—45——88
Race and ethnicity, No (%) — Other (including American Indian or Alaska Native)73—71——144
Region of Enrollment
Region of Enrollment(Participants)Water Access and Promotion - StudentsWater Access and Promotion - School PersonnelControl - StudentsControl - School PersonnelFood Service DirectorsTotal
United States6771057212131284
08

Study locations

1 site
  • Stanford
    Stanford, California 94305-5119, United States
09

References and documents

Publications

  • 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. PubMed 35537674 ↗
  • 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. PubMed 33370616 ↗
  • 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. PubMed 37545466 ↗

Study documents

  • Study protocol · Feb 29, 2024
  • Statistical analysis plan · Feb 29, 2024
  • Informed consent form · Feb 29, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03181971
Lead sponsor
Stanford University
Collaborators
University of California, San Francisco, University of California
Responsible party
Anisha I Patel (Professor, Stanford University) — Principal investigator
First posted
Jun 9, 2017
Start date
Aug 1, 2016
Primary completion
May 25, 2022
Completion
May 27, 2022
Results posted
Jun 27, 2024
Last update
Jun 27, 2024

Study contacts

Anisha Patel, MD, MSPH
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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