Trial Outcomes & Findings for School Water Access, Food and Beverage Intake, and Obesity (NCT NCT03181971)

NCT ID: NCT03181971

Last Updated: 2024-06-27

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1861 participants

Primary outcome timeframe

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

Results posted on

2024-06-27

Participant Flow

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

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

Unit of analysis: Schools

Participant milestones

Participant milestones
Measure	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). School personnel complete surveys on school policies and procedures.	Control - Students Schools do not receive the intervention. School personnel complete surveys on school policies and procedures.	Food Service Directors District-level Food Service Directors complete surveys on school policies and procedures.
Overall Study STARTED	690 9	594 9	13 0
Overall Study Students Who Started the Study	680 9	582 9	0 0
Overall Study Adults Who Started Study	10 9	12 9	13 0
Overall Study Students That Received Allocated Intervention / Participated in Allocated Control	677 9	572 9	0 0
Overall Study Students Who Completed the Study	548 9	510 9	0 0
Overall Study Adults Who Completed the Study	10 9	12 9	13 0
Overall Study COMPLETED	558 9	522 9	13 0
Overall Study NOT COMPLETED	132 0	72 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age data were not gathered from the adult participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Water Access and Promotion - Students n=677 Participants 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).	Water Access and Promotion - School Personnel n=10 Participants Schools receive installation of water stations in high traffic areas, schoolwide promotion (intervention group). School personnel complete surveys on school policies and procedures.	Control - Students n=572 Participants Schools do not receive an intervention.	Control - School Personnel n=12 Participants Schools do not receive an intervention. School personnel complete surveys on school policies and procedures.	Food Service Directors n=13 Participants District-level Food Service Directors complete surveys on school policies and procedures.	Total n=1284 Participants Total of all reporting groups
Age, Continuous	9.6 years STANDARD_DEVIATION 0.4 • n=677 Participants • Age data were not gathered from the adult participants.	—	9.6 years STANDARD_DEVIATION 0.4 • n=572 Participants • Age data were not gathered from the adult participants.	—	—	9.6 years STANDARD_DEVIATION 0.4 • n=1249 Participants • Age data were not gathered from the adult participants.
Sex: Female, Male Female	318 Participants n=677 Participants	5 Participants n=10 Participants	274 Participants n=572 Participants	6 Participants n=12 Participants	13 Participants n=13 Participants	616 Participants n=1284 Participants
Sex: Female, Male Male	359 Participants n=677 Participants	5 Participants n=10 Participants	298 Participants n=572 Participants	6 Participants n=12 Participants	0 Participants n=13 Participants	668 Participants n=1284 Participants
Race/Ethnicity, Customized Race and ethnicity, No (%) · Mexican American, Latino, Hispanic	455 Participants n=677 Participants • Race/ethnicity data were not gathered from the adult participants.	—	337 Participants n=572 Participants • Race/ethnicity data were not gathered from the adult participants.	—	—	792 Participants n=1249 Participants • Race/ethnicity data were not gathered from the adult participants.
Race/Ethnicity, Customized Race and ethnicity, No (%) · Non-Hispanic Asian	80 Participants n=677 Participants • Race/ethnicity data were not gathered from the adult participants.	—	94 Participants n=572 Participants • Race/ethnicity data were not gathered from the adult participants.	—	—	174 Participants n=1249 Participants • Race/ethnicity data were not gathered from the adult participants.
Race/Ethnicity, Customized Race and ethnicity, No (%) · Non-Hispanic Black	26 Participants n=677 Participants • Race/ethnicity data were not gathered from the adult participants.	—	25 Participants n=572 Participants • Race/ethnicity data were not gathered from the adult participants.	—	—	51 Participants n=1249 Participants • Race/ethnicity data were not gathered from the adult participants.
Race/Ethnicity, Customized Race and ethnicity, No (%) · Non-Hispanic White	43 Participants n=677 Participants • Race/ethnicity data were not gathered from the adult participants.	—	45 Participants n=572 Participants • Race/ethnicity data were not gathered from the adult participants.	—	—	88 Participants n=1249 Participants • Race/ethnicity data were not gathered from the adult participants.
Race/Ethnicity, Customized Race and ethnicity, No (%) · Other (including American Indian or Alaska Native)	73 Participants n=677 Participants • Race/ethnicity data were not gathered from the adult participants.	—	71 Participants n=572 Participants • Race/ethnicity data were not gathered from the adult participants.	—	—	144 Participants n=1249 Participants • Race/ethnicity data were not gathered from the adult participants.
Region of Enrollment United States	677 Participants n=677 Participants	10 Participants n=10 Participants	572 Participants n=572 Participants	12 Participants n=12 Participants	13 Participants n=13 Participants	1284 Participants n=1284 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Water Access and Promotion - Students n=677 Participants Intervention group receives installation of water stations in high traffic areas, schoolwide promotion, and 4th graders receive a curricula focused on increasing intake of water.	Control - Students n=572 Participants Participants do not receive an intervention
Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 85% Baseline	335 Participants	273 Participants
Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 85% Month 7	315 Participants	263 Participants
Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 85% Month 15	274 Participants	262 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Water Access and Promotion - Students n=677 Participants Intervention group receives installation of water stations in high traffic areas, schoolwide promotion, and 4th graders receive a curricula focused on increasing intake of water.	Control - Students n=572 Participants Participants do not receive an intervention
Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 95%. Yes or No. Baseline	222 Participants	165 Participants
Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 95%. Yes or No. Month 7	202 Participants	159 Participants
Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 95%. Yes or No. Month 15	179 Participants	144 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Water Access and Promotion - Students n=677 Participants Intervention group receives installation of water stations in high traffic areas, schoolwide promotion, and 4th graders receive a curricula focused on increasing intake of water.	Control - Students n=572 Participants Participants do not receive an intervention
BMI Percentile,Mean(SD) Baseline	73.2 BMI-for-age/sex percentile Standard Deviation 28.1	71.9 BMI-for-age/sex percentile Standard Deviation 28.7
BMI Percentile,Mean(SD) Month 7	73.7 BMI-for-age/sex percentile Standard Deviation 27.1	71.8 BMI-for-age/sex percentile Standard Deviation 28.4
BMI Percentile,Mean(SD) Month 15	73.5 BMI-for-age/sex percentile Standard Deviation 28.0	72.9 BMI-for-age/sex percentile Standard Deviation 28.5

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Water Access and Promotion - Students n=677 Participants Intervention group receives installation of water stations in high traffic areas, schoolwide promotion, and 4th graders receive a curricula focused on increasing intake of water.	Control - Students n=572 Participants Participants do not receive an intervention
BMI, Mean (SD) Baseline	20.4 kg/m^2 Standard Deviation 4.6	20.1 kg/m^2 Standard Deviation 4.6
BMI, Mean (SD) Month 7	20.9 kg/m^2 Standard Deviation 4.7	20.5 kg/m^2 Standard Deviation 4.7
BMI, Mean (SD) Month 15	21.4 kg/m^2 Standard Deviation 5.1	21.2 kg/m^2 Standard Deviation 4.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Water Access and Promotion - Students n=677 Participants Intervention group receives installation of water stations in high traffic areas, schoolwide promotion, and 4th graders receive a curricula focused on increasing intake of water.	Control - Students n=572 Participants Participants do not receive an intervention
BMI Z-score, Mean (SD) Month 15	0.9 z-score Standard Deviation 1.1	0.9 z-score Standard Deviation 1.1
BMI Z-score, Mean (SD) Baseline	0.9 z-score Standard Deviation 1.1	0.8 z-score Standard Deviation 1.1
BMI Z-score, Mean (SD) Month 7	0.9 z-score Standard Deviation 1.1	0.8 z-score Standard Deviation 1.1

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Water Access and Promotion - Students n=647 Participants Intervention group receives installation of water stations in high traffic areas, schoolwide promotion, and 4th graders receive a curricula focused on increasing intake of water.	Control - Students n=548 Participants Participants do not receive an intervention
Caloric Intake Total - baseline	1636 kcal/day Standard Deviation 796	1699 kcal/day Standard Deviation 727
Caloric Intake Total - month 7	1610 kcal/day Standard Deviation 805	1676 kcal/day Standard Deviation 782
Caloric Intake Food - baseline	1371 kcal/day Standard Deviation 705	1434 kcal/day Standard Deviation 654
Caloric Intake Food - month 7	1380 kcal/day Standard Deviation 727	1425 kcal/day Standard Deviation 696
Caloric Intake Beverage - baseline	265 kcal/day Standard Deviation 214	265 kcal/day Standard Deviation 212
Caloric Intake Beverage - month 7	229 kcal/day Standard Deviation 227	251 kcal/day Standard Deviation 231
Caloric Intake Sugar-sweetened beverage (SSB) - baseline	223 kcal/day Standard Deviation 205	223 kcal/day Standard Deviation 204
Caloric Intake SSB - month 7	190 kcal/day Standard Deviation 199	214 kcal/day Standard Deviation 223

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Water Access and Promotion - Students n=647 Participants Intervention group receives installation of water stations in high traffic areas, schoolwide promotion, and 4th graders receive a curricula focused on increasing intake of water.	Control - Students n=548 Participants Participants do not receive an intervention
Water Intake - Grams Consumed Baseline	414 grams/day Standard Deviation 443	454 grams/day Standard Deviation 441
Water Intake - Grams Consumed Month 7	462 grams/day Standard Deviation 576	441 grams/day Standard Deviation 472

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Water Access and Promotion - Students n=677 Participants Intervention group receives installation of water stations in high traffic areas, schoolwide promotion, and 4th graders receive a curricula focused on increasing intake of water.	Control - Students n=572 Participants Participants do not receive an intervention
Beverage Intake Water - baseline	6.1 times per day Standard Deviation 4.3	5.7 times per day Standard Deviation 4.2
Beverage Intake Water - month 7	7.1 times per day Standard Deviation 5.2	5.2 times per day Standard Deviation 3.9
Beverage Intake Water - month 15	6.2 times per day Standard Deviation 4.7	4.8 times per day Standard Deviation 3.8
Beverage Intake SSB - baseline	3.5 times per day Standard Deviation 4.2	3.5 times per day Standard Deviation 4.2
Beverage Intake SSB - month 7	2.4 times per day Standard Deviation 3.5	2.8 times per day Standard Deviation 3.7
Beverage Intake SSB - month 15	2.1 times per day Standard Deviation 2.8	2.2 times per day Standard Deviation 2.9
Beverage Intake Juice - baseline	0.8 times per day Standard Deviation 1.1	0.8 times per day Standard Deviation 1.1
Beverage Intake Juice - month 7	0.6 times per day Standard Deviation 1.0	0.6 times per day Standard Deviation 0.8
Beverage Intake Juice - month 15	0.5 times per day Standard Deviation 1.0	0.5 times per day Standard Deviation 0.9
Beverage Intake Flavored milk - baseline	0.5 times per day Standard Deviation 0.9	0.5 times per day Standard Deviation 0.9
Beverage Intake Flavored milk - month 7	0.4 times per day Standard Deviation 0.7	0.4 times per day Standard Deviation 0.8
Beverage Intake Flavored milk - month 15	0.4 times per day Standard Deviation 0.8	0.4 times per day Standard Deviation 0.9
Beverage Intake Plain milk - baseline	1.2 times per day Standard Deviation 1.4	1.1 times per day Standard Deviation 1.3
Beverage Intake Plain milk - month 7	1.2 times per day Standard Deviation 1.6	1.0 times per day Standard Deviation 1.2
Beverage Intake Plain milk - month 15	1.1 times per day Standard Deviation 1.4	1.0 times per day Standard Deviation 1.2

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Water Access and Promotion - Students n=4091 Participants Intervention group receives installation of water stations in high traffic areas, schoolwide promotion, and 4th graders receive a curricula focused on increasing intake of water.	Control - Students n=3947 Participants Participants do not receive an intervention
Water Intake Lunch - baseline	3.5 observations Standard Deviation 6.1	3.7 observations Standard Deviation 6.1
Water Intake Lunch - month 7	38.3 observations Standard Deviation 15.9	3.6 observations Standard Deviation 4.7
Water Intake Lunch - month 15	9.2 observations Standard Deviation 7.7	3.2 observations Standard Deviation 3.1
Water Intake Recess - baseline	6.5 observations Standard Deviation 3.4	6.1 observations Standard Deviation 4.5
Water Intake Recess - month 7	29.3 observations Standard Deviation 36.5	6.6 observations Standard Deviation 4.1
Water Intake Recess - month 15	8.8 observations Standard Deviation 3.1	3.3 observations Standard Deviation 3.0
Water Intake PE class - baseline	66.6 observations Standard Deviation 87.8	47.4 observations Standard Deviation 32.2
Water Intake PE class - month 7	89.6 observations Standard Deviation 58.7	53.2 observations Standard Deviation 65.6
Water Intake PE class - month 15	95.0 observations Standard Deviation 56.2	43.1 observations Standard Deviation 38.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 15-months after the start of the study

School administrators and food service director surveys of nutrition and physical activity policies and practices at schools

Outcome measures

Outcome data not reported

Adverse Events

Water Access and Promotion - Students

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Water Access and Promotion - School Personnel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control - Students

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control - School Personnel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Food Service Directors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Water Access and Promotion - Students n=680 participants at risk 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).	Water Access and Promotion - School Personnel n=10 participants at risk Schools receive installation of water stations in high traffic areas, schoolwide promotion (intervention group). School personnel complete surveys on school policies and procedures.	Control - Students n=582 participants at risk Schools do not receive an intervention.	Control - School Personnel n=12 participants at risk Schools do not receive an intervention. School personnel complete surveys on school policies and procedures.	Food Service Directors n=13 participants at risk District-level Food Service Directors complete surveys on school policies and procedures.
General disorders Death	0.15% 1/680 • 15 months	0.00% 0/10 • 15 months	0.00% 0/582 • 15 months	0.00% 0/12 • 15 months	0.00% 0/13 • 15 months

Other adverse events

Adverse event data not reported

Additional Information

Anisha Patel, MD

Stanford University

Phone: (650) 497-1181

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place