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School Water Access, Food and Beverage Intake, and Obesity

The Impact of the School Water Access on Child Food and Beverage Intake and Obesity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03181971
Enrollment
1861
Registered
2017-06-09
Start date
2016-08-01
Completion date
2022-05-27
Last updated
2024-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

water, sugar-sweetened beverages, schools

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.

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.

Sponsors

University of California, San Francisco
CollaboratorOTHER
University of California
CollaboratorOTHER
Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to 100 Years
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

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
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.Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual.
BMI Percentile,Mean(SD)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, Mean (SD)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-score, Mean (SD)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 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.
Water Intake - Grams ConsumedBaseline and 7-monthsFood and beverage diaries will be used to calculate daily water intake.
Beverage IntakeBaseline, 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 IntakeBaseline, 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.
Caloric IntakeBaseline and 7-months after the start of the studyFood and beverage diaries will be used to calculate daily caloric intake from foods and beverages.

Other

MeasureTime frameDescription
School Policies and PracticesBaseline and 15-months after the start of the studySchool administrators and food service director surveys of nutrition and physical activity policies and practices at schools

Countries

United States

Participant flow

Recruitment details

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

Pre-assignment details

1861 students and adults signed consent; 564 students and adults could not be in the study due to pandemic school closures.

Participants by arm

ArmCount
Water Access and Promotion - Students
Schools receive installation of water stations in high traffic areas, schoolwide promotion, and 4th graders receive a curricula focused on increasing intake of water (intervention group).
677
Water Access and Promotion - School Personnel
Schools receive installation of water stations in high traffic areas, schoolwide promotion (intervention group). School personnel complete surveys on school policies and procedures.
10
Control - Students
Schools do not receive an intervention.
572
Control - School Personnel
Schools do not receive an intervention. School personnel complete surveys on school policies and procedures.
12
Food Service Directors
District-level Food Service Directors complete surveys on school policies and procedures.
13
Total1,284

Baseline characteristics

CharacteristicControl - StudentsTotalWater Access and Promotion - StudentsControl - School PersonnelFood Service DirectorsWater Access and Promotion - School Personnel
Age, Continuous9.6 years
STANDARD_DEVIATION 0.4
9.6 years
STANDARD_DEVIATION 0.4
9.6 years
STANDARD_DEVIATION 0.4
Race/Ethnicity, Customized
Race and ethnicity, No (%)
Mexican American, Latino, Hispanic
337 Participants792 Participants455 Participants
Race/Ethnicity, Customized
Race and ethnicity, No (%)
Non-Hispanic Asian
94 Participants174 Participants80 Participants
Race/Ethnicity, Customized
Race and ethnicity, No (%)
Non-Hispanic Black
25 Participants51 Participants26 Participants
Race/Ethnicity, Customized
Race and ethnicity, No (%)
Non-Hispanic White
45 Participants88 Participants43 Participants
Race/Ethnicity, Customized
Race and ethnicity, No (%)
Other (including American Indian or Alaska Native)
71 Participants144 Participants73 Participants
Region of Enrollment
United States
572 Participants1284 Participants677 Participants12 Participants13 Participants10 Participants
Sex: Female, Male
Female
274 Participants616 Participants318 Participants6 Participants13 Participants5 Participants
Sex: Female, Male
Male
298 Participants668 Participants359 Participants6 Participants0 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
1 / 6800 / 100 / 5820 / 120 / 13
other
Total, other adverse events
0 / 6800 / 100 / 5820 / 120 / 13
serious
Total, serious adverse events
1 / 6800 / 100 / 5820 / 120 / 13

Outcome results

Primary

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.

Population: Outcome measure data were collected from students only. Participants with data at each respective time point are included in the analysis.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Water Access and Promotion - StudentsNumber of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 85%Baseline335 Participants
Water Access and Promotion - StudentsNumber of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 85%Month 7315 Participants
Water Access and Promotion - StudentsNumber of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 85%Month 15274 Participants
Control - StudentsNumber of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 85%Baseline273 Participants
Control - StudentsNumber of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 85%Month 7263 Participants
Control - StudentsNumber of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 85%Month 15262 Participants
Comparison: Analysis of between group change from baseline to 7 months.p-value: 0.6895% CI: [0.2, 2.9]Mixed Models Analysis
Comparison: Analysis of between group change from baseline to 15 monthsp-value: 0.01795% CI: [0.03, 0.7]Mixed Models Analysis
Secondary

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.

Population: Outcome measure data were collected from students only. Participants with data at each respective time point are included in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Water Access and Promotion - StudentsBeverage IntakeSSB - month 152.1 times per dayStandard Deviation 2.8
Water Access and Promotion - StudentsBeverage IntakeWater - month 77.1 times per dayStandard Deviation 5.2
Water Access and Promotion - StudentsBeverage IntakeJuice - month 150.5 times per dayStandard Deviation 1
Water Access and Promotion - StudentsBeverage IntakeFlavored milk - baseline0.5 times per dayStandard Deviation 0.9
Water Access and Promotion - StudentsBeverage IntakeWater - month 156.2 times per dayStandard Deviation 4.7
Water Access and Promotion - StudentsBeverage IntakeFlavored milk - month 70.4 times per dayStandard Deviation 0.7
Water Access and Promotion - StudentsBeverage IntakeJuice - baseline0.8 times per dayStandard Deviation 1.1
Water Access and Promotion - StudentsBeverage IntakeFlavored milk - month 150.4 times per dayStandard Deviation 0.8
Water Access and Promotion - StudentsBeverage IntakeSSB - baseline3.5 times per dayStandard Deviation 4.2
Water Access and Promotion - StudentsBeverage IntakePlain milk - baseline1.2 times per dayStandard Deviation 1.4
Water Access and Promotion - StudentsBeverage IntakeWater - baseline6.1 times per dayStandard Deviation 4.3
Water Access and Promotion - StudentsBeverage IntakePlain milk - month 71.2 times per dayStandard Deviation 1.6
Water Access and Promotion - StudentsBeverage IntakeSSB - month 72.4 times per dayStandard Deviation 3.5
Water Access and Promotion - StudentsBeverage IntakePlain milk - month 151.1 times per dayStandard Deviation 1.4
Water Access and Promotion - StudentsBeverage IntakeJuice - month 70.6 times per dayStandard Deviation 1
Control - StudentsBeverage IntakePlain milk - month 151.0 times per dayStandard Deviation 1.2
Control - StudentsBeverage IntakeJuice - month 70.6 times per dayStandard Deviation 0.8
Control - StudentsBeverage IntakeWater - baseline5.7 times per dayStandard Deviation 4.2
Control - StudentsBeverage IntakeWater - month 75.2 times per dayStandard Deviation 3.9
Control - StudentsBeverage IntakeWater - month 154.8 times per dayStandard Deviation 3.8
Control - StudentsBeverage IntakeSSB - baseline3.5 times per dayStandard Deviation 4.2
Control - StudentsBeverage IntakeSSB - month 72.8 times per dayStandard Deviation 3.7
Control - StudentsBeverage IntakeSSB - month 152.2 times per dayStandard Deviation 2.9
Control - StudentsBeverage IntakeJuice - month 150.5 times per dayStandard Deviation 0.9
Control - StudentsBeverage IntakeFlavored milk - baseline0.5 times per dayStandard Deviation 0.9
Control - StudentsBeverage IntakeFlavored milk - month 70.4 times per dayStandard Deviation 0.8
Control - StudentsBeverage IntakeFlavored milk - month 150.4 times per dayStandard Deviation 0.9
Control - StudentsBeverage IntakePlain milk - baseline1.1 times per dayStandard Deviation 1.3
Control - StudentsBeverage IntakePlain milk - month 71.0 times per dayStandard Deviation 1.2
Control - StudentsBeverage IntakeJuice - baseline0.8 times per dayStandard Deviation 1.1
Comparison: Analysis of between group change in water intake from baseline to 7 months.p-value: <0.00195% CI: [13.1, 34.2]Mixed Models Analysis
Comparison: Analysis of between group change in water intake from baseline to 15 months.p-value: 0.00495% CI: [4.5, 25.9]Mixed Models Analysis
Comparison: Analysis of between group change in SSB intake from baseline to 7 months.p-value: 0.06395% CI: [-15.7, 0.4]Mixed Models Analysis
Comparison: Analysis of between group change in SSB intake from baseline to 15 months.p-value: 0.5695% CI: [-11.7, 6.9]Mixed Models Analysis
Comparison: Analysis of between group change in juice intake from baseline to 7 months.p-value: 0.6895% CI: [-4.3, 7]Mixed Models Analysis
Comparison: Analysis of between group change in juice intake from baseline to 15 months.p-value: 0.6695% CI: [-7.4, 5]Mixed Models Analysis
Comparison: Analysis of between group change in flavored milk intake from baseline to 7 months.p-value: 0.07995% CI: [-8.3, 0.5]Mixed Models Analysis
Comparison: Analysis of between group change in flavored milk intake from baseline to 15 months.p-value: 0.2695% CI: [-8, 2.3]Mixed Models Analysis
Comparison: Analysis of between group change in plain milk intake from baseline to 7 months.p-value: 0.295% CI: [-2.2, 11.5]Mixed Models Analysis
Comparison: Analysis of between group change in plain milk intake from baseline to 15 months.p-value: 0.5195% CI: [-4.4, 9.6]Mixed Models Analysis
Secondary

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.

Population: Outcome measure data were collected from students only. Participants with data at each respective time point are included in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Water Access and Promotion - StudentsBMI, Mean (SD)Baseline20.4 kg/m^2Standard Deviation 4.6
Water Access and Promotion - StudentsBMI, Mean (SD)Month 720.9 kg/m^2Standard Deviation 4.7
Water Access and Promotion - StudentsBMI, Mean (SD)Month 1521.4 kg/m^2Standard Deviation 5.1
Control - StudentsBMI, Mean (SD)Baseline20.1 kg/m^2Standard Deviation 4.6
Control - StudentsBMI, Mean (SD)Month 720.5 kg/m^2Standard Deviation 4.7
Control - StudentsBMI, Mean (SD)Month 1521.2 kg/m^2Standard Deviation 4.9
Comparison: Analysis of between group change from baseline to 7 months.p-value: 0.4695% CI: [-0.06, 0.1]Mixed Models Analysis
Comparison: Analysis of between group change from baseline to 15 months.p-value: 0.895% CI: [-0.2, 0.1]Mixed Models Analysis
Secondary

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.

Population: Outcome measure data were collected from students only. Participants with data at each respective time point are included in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Water Access and Promotion - StudentsBMI Percentile,Mean(SD)Month 1573.5 BMI-for-age/sex percentileStandard Deviation 28
Water Access and Promotion - StudentsBMI Percentile,Mean(SD)Baseline73.2 BMI-for-age/sex percentileStandard Deviation 28.1
Water Access and Promotion - StudentsBMI Percentile,Mean(SD)Month 773.7 BMI-for-age/sex percentileStandard Deviation 27.1
Control - StudentsBMI Percentile,Mean(SD)Baseline71.9 BMI-for-age/sex percentileStandard Deviation 28.7
Control - StudentsBMI Percentile,Mean(SD)Month 771.8 BMI-for-age/sex percentileStandard Deviation 28.4
Control - StudentsBMI Percentile,Mean(SD)Month 1572.9 BMI-for-age/sex percentileStandard Deviation 28.5
Comparison: Analysis of between group change from baseline to 7 months.p-value: 0.5795% CI: [-0.6, 1]Mixed Models Analysis
Comparison: Analysis of between group change from baseline to 15 months.p-value: 0.495% CI: [-1.5, 0.6]Mixed Models Analysis
Secondary

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.

Population: Outcome measure data were collected from students only. Participants with data at each respective time point are included in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Water Access and Promotion - StudentsBMI Z-score, Mean (SD)Baseline0.9 z-scoreStandard Deviation 1.1
Water Access and Promotion - StudentsBMI Z-score, Mean (SD)Month 70.9 z-scoreStandard Deviation 1.1
Water Access and Promotion - StudentsBMI Z-score, Mean (SD)Month 150.9 z-scoreStandard Deviation 1.1
Control - StudentsBMI Z-score, Mean (SD)Baseline0.8 z-scoreStandard Deviation 1.1
Control - StudentsBMI Z-score, Mean (SD)Month 70.8 z-scoreStandard Deviation 1.1
Control - StudentsBMI Z-score, Mean (SD)Month 150.9 z-scoreStandard Deviation 1.1
Comparison: Analysis of between group change from baseline to 7 months.p-value: 0.9395% CI: [-0.03, 0.03]Mixed Models Analysis
Comparison: Analysis of between group change from baseline to 15 months.p-value: 0.3695% CI: [-0.06, 0.02]Mixed Models Analysis
Secondary

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

Population: Outcome measure data were collected from students only. Participants with data at each respective time point are included in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Water Access and Promotion - StudentsCaloric IntakeTotal - baseline1636 kcal/dayStandard Deviation 796
Water Access and Promotion - StudentsCaloric IntakeTotal - month 71610 kcal/dayStandard Deviation 805
Water Access and Promotion - StudentsCaloric IntakeFood - baseline1371 kcal/dayStandard Deviation 705
Water Access and Promotion - StudentsCaloric IntakeFood - month 71380 kcal/dayStandard Deviation 727
Water Access and Promotion - StudentsCaloric IntakeBeverage - baseline265 kcal/dayStandard Deviation 214
Water Access and Promotion - StudentsCaloric IntakeBeverage - month 7229 kcal/dayStandard Deviation 227
Water Access and Promotion - StudentsCaloric IntakeSugar-sweetened beverage (SSB) - baseline223 kcal/dayStandard Deviation 205
Water Access and Promotion - StudentsCaloric IntakeSSB - month 7190 kcal/dayStandard Deviation 199
Control - StudentsCaloric IntakeSSB - month 7214 kcal/dayStandard Deviation 223
Control - StudentsCaloric IntakeTotal - baseline1699 kcal/dayStandard Deviation 727
Control - StudentsCaloric IntakeBeverage - baseline265 kcal/dayStandard Deviation 212
Control - StudentsCaloric IntakeTotal - month 71676 kcal/dayStandard Deviation 782
Control - StudentsCaloric IntakeSugar-sweetened beverage (SSB) - baseline223 kcal/dayStandard Deviation 204
Control - StudentsCaloric IntakeFood - baseline1434 kcal/dayStandard Deviation 654
Control - StudentsCaloric IntakeBeverage - month 7251 kcal/dayStandard Deviation 231
Control - StudentsCaloric IntakeFood - month 71425 kcal/dayStandard Deviation 696
Comparison: Analysis of between group change in total kcal intake from baseline to 7 months.p-value: 0.795% CI: [-5.3, 8.5]Mixed Models Analysis
Comparison: Analysis of between group change in intake of food kcal from baseline to 7 months.p-value: 0.3595% CI: [-3.9, 12]Mixed Models Analysis
Comparison: Analysis of between group change in intake of beverage kcal from baseline to 7 months.p-value: 0.3595% CI: [-29.2, 8.8]Mixed Models Analysis
Comparison: Analysis of between group change in SSB kcal from baseline to 7 months.p-value: 0.1895% CI: [-37.8, 9.6]Mixed Models Analysis
Secondary

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.

Population: Outcome measure data were collected from students only. Participants with data at each respective time point are included in the analysis.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Water Access and Promotion - StudentsNumber of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 95%. Yes or No.Baseline222 Participants
Water Access and Promotion - StudentsNumber of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 95%. Yes or No.Month 7202 Participants
Water Access and Promotion - StudentsNumber of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 95%. Yes or No.Month 15179 Participants
Control - StudentsNumber of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 95%. Yes or No.Baseline165 Participants
Control - StudentsNumber of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 95%. Yes or No.Month 7159 Participants
Control - StudentsNumber of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 95%. Yes or No.Month 15144 Participants
Comparison: Analysis of between group change from baseline to 7 months.p-value: 0.2495% CI: [0.07, 2]Mixed Models Analysis
Comparison: Analysis of between group change from baseline to 15 months.p-value: 0.9895% CI: [0.1, 7]Mixed Models Analysis
Secondary

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.

Population: Data were collected from students from participating schools, whether the students were enrolled in the study, or not. For each observation type (lunchtime, PE class, and recess) and period, the number estimated in the census at each respective time point are included in the analysis. Outcome measure data were not collected from adults.

ArmMeasureGroupValue (MEAN)Dispersion
Water Access and Promotion - StudentsWater IntakeLunch - month 738.3 observationsStandard Deviation 15.9
Water Access and Promotion - StudentsWater IntakeRecess - month 158.8 observationsStandard Deviation 3.1
Water Access and Promotion - StudentsWater IntakeRecess - baseline6.5 observationsStandard Deviation 3.4
Water Access and Promotion - StudentsWater IntakePE class - baseline66.6 observationsStandard Deviation 87.8
Water Access and Promotion - StudentsWater IntakeLunch - month 159.2 observationsStandard Deviation 7.7
Water Access and Promotion - StudentsWater IntakePE class - month 789.6 observationsStandard Deviation 58.7
Water Access and Promotion - StudentsWater IntakeRecess - month 729.3 observationsStandard Deviation 36.5
Water Access and Promotion - StudentsWater IntakePE class - month 1595.0 observationsStandard Deviation 56.2
Water Access and Promotion - StudentsWater IntakeLunch - baseline3.5 observationsStandard Deviation 6.1
Control - StudentsWater IntakePE class - month 1543.1 observationsStandard Deviation 38.1
Control - StudentsWater IntakeLunch - baseline3.7 observationsStandard Deviation 6.1
Control - StudentsWater IntakeLunch - month 73.6 observationsStandard Deviation 4.7
Control - StudentsWater IntakeLunch - month 153.2 observationsStandard Deviation 3.1
Control - StudentsWater IntakeRecess - baseline6.1 observationsStandard Deviation 4.5
Control - StudentsWater IntakeRecess - month 76.6 observationsStandard Deviation 4.1
Control - StudentsWater IntakeRecess - month 153.3 observationsStandard Deviation 3
Control - StudentsWater IntakePE class - baseline47.4 observationsStandard Deviation 32.2
Control - StudentsWater IntakePE class - month 753.2 observationsStandard Deviation 65.6
Comparison: Analysis of between group change in water intake from water source at lunch from baseline to 7 months.p-value: <0.00195% CI: [21.2, 42.2]Mixed Models Analysis
Comparison: Analysis of between group change in water intake from water source during lunch from baseline to 15 months.p-value: 0.2295% CI: [-3, 13.5]Mixed Models Analysis
Comparison: Analysis of between group change in water intake from water source at recess from baseline to 7 months.p-value: 0.0295% CI: [2.6, 33.3]Mixed Models Analysis
Comparison: Analysis of between group change in water intake from water source at recess from baseline to 15 months.p-value: 0.4895% CI: [-8, 19.2]Mixed Models Analysis
Comparison: Analysis of between group change in water intake from water source at PE from baseline to 7 months.p-value: 0.1495% CI: [-9.4, 99.8]Mixed Models Analysis
Comparison: Analysis of between group change in water intake from water source at PE from baseline to 15 months.p-value: 0.1695% CI: [-11, 96.2]Mixed Models Analysis
Secondary

Water Intake - Grams Consumed

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

Time frame: Baseline and 7-months

Population: Outcome measure data were collected from students only. Participants with data at each respective time point are included in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Water Access and Promotion - StudentsWater Intake - Grams ConsumedBaseline414 grams/dayStandard Deviation 443
Water Access and Promotion - StudentsWater Intake - Grams ConsumedMonth 7462 grams/dayStandard Deviation 576
Control - StudentsWater Intake - Grams ConsumedBaseline454 grams/dayStandard Deviation 441
Control - StudentsWater Intake - Grams ConsumedMonth 7441 grams/dayStandard Deviation 472
Comparison: Analysis of between group change from baseline to 7 months.p-value: 0.5995% CI: [-20.6, 49.9]Mixed Models Analysis
Other Pre-specified

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

Source: ClinicalTrials.gov · Data processed: Jun 15, 2026