Trial Outcomes & Findings for Childcare Healthy Beverage Access, Food and Beverage Intake, and Obesity (NCT NCT05112185)
NCT ID: NCT05112185
Last Updated: 2026-09-01
Results Overview
Trained research staff measure children's 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 to quantify how far a child's anthropometry measurement deviates from the median of a reference population. The score is calculated using the sex, age, weight, and height of the participant, and is based on growth references for children. A z-score of 0 reflects the 50th percentile (the median) of the reference growth charts. For example, a z-score of 1.5 indicates a child is 1.5 standard deviation units above the reference median, whereas a z-score of -1.5 means a child is 1.5 below it, adjusting for childhood BMI distributions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1034 participants
Primary outcome timeframe
Baseline, 6-months, and 10-months after the start of the study.
Results posted on
2026-09-01
Participant Flow
This study enrolled preschool-aged children in participating licensed childcare centers serving predominantly low-income families, their parents or legal guardians, and childcare providers working in participating childcare centers who implemented study activities and center-level practices.
Unit of analysis: Child Care Centers
Participant milestones
| Measure |
Healthy Beverage Access and Promotion
Intervention group receives supports to increase access to water at mealtimes and throughout the day, individualized education to help families set healthy drinks goals, and a curricula focused on increasing intake of water and healthy beverages.
|
Control Group
Participants receive usual care during the study, and are provided intervention materials at study conclusion.
|
|---|---|---|
|
Overall Study
STARTED
|
518 7
|
516 7
|
|
Overall Study
Children Who Started the Study
|
246 7
|
244 7
|
|
Overall Study
Parents Who Started the Study
|
248 7
|
245 7
|
|
Overall Study
Child Care Providers Who Started the Study
|
24 7
|
27 7
|
|
Overall Study
Children Who Completed the Study
|
226 7
|
229 7
|
|
Overall Study
Parents Who Completed the Study
|
228 7
|
231 7
|
|
Overall Study
Child Care Providers Who Completed the Study
|
21 7
|
22 7
|
|
Overall Study
COMPLETED
|
475 7
|
482 7
|
|
Overall Study
NOT COMPLETED
|
43 0
|
34 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Not all parents completed age data entry in the baseline survey.
Baseline characteristics by cohort
| Measure |
Healthy Beverage Access and Promotion - Children
n=246 Participants
Intervention group receives supports to increase access to water at mealtimes and throughout the day, individualized education to help families set healthy drinks goals, and a curricula focused on increasing intake of water and healthy beverages.
|
Healthy Beverage Access and Promotion - Parents
n=248 Participants
Intervention group receives supports to increase access to water at mealtimes and throughout the day, individualized education to help families set healthy drinks goals, and a curricula focused on increasing intake of water and healthy beverages.
|
Healthy Beverage Access and Promotion - Providers
n=24 Participants
Intervention group receives supports to increase access to water at mealtimes and throughout the day, individualized education to help families set healthy drinks goals, and a curricula focused on increasing intake of water and healthy beverages.
|
Control Group - Children
n=244 Participants
Participants receive usual care during the study, and are provided intervention materials at study conclusion.
|
Control Group - Parents
n=245 Participants
Participants receive usual care during the study, and are provided intervention materials at study conclusion.
|
Control Group - Providers
n=27 Participants
Participants receive usual care during the study, and are provided intervention materials at study conclusion.
|
Total
n=1034 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
3.44 Years
STANDARD_DEVIATION 0.68 • n=246 Participants • Not all parents completed age data entry in the baseline survey.
|
31.92 Years
STANDARD_DEVIATION 6.38 • n=220 Participants • Not all parents completed age data entry in the baseline survey.
|
42.83 Years
STANDARD_DEVIATION 11.45 • n=24 Participants • Not all parents completed age data entry in the baseline survey.
|
3.44 Years
STANDARD_DEVIATION 0.73 • n=244 Participants • Not all parents completed age data entry in the baseline survey.
|
32.67 Years
STANDARD_DEVIATION 7.16 • n=226 Participants • Not all parents completed age data entry in the baseline survey.
|
44.85 Years
STANDARD_DEVIATION 10.65 • n=27 Participants • Not all parents completed age data entry in the baseline survey.
|
18.57 Years
STANDARD_DEVIATION 16.11 • n=987 Participants • Not all parents completed age data entry in the baseline survey.
|
|
Sex: Female, Male
Female
|
138 Participants
n=246 Participants • Not all parents completed sex data entry in the baseline survey.
|
203 Participants
n=220 Participants • Not all parents completed sex data entry in the baseline survey.
|
24 Participants
n=24 Participants • Not all parents completed sex data entry in the baseline survey.
|
127 Participants
n=244 Participants • Not all parents completed sex data entry in the baseline survey.
|
209 Participants
n=227 Participants • Not all parents completed sex data entry in the baseline survey.
|
27 Participants
n=27 Participants • Not all parents completed sex data entry in the baseline survey.
|
728 Participants
n=988 Participants • Not all parents completed sex data entry in the baseline survey.
|
|
Sex: Female, Male
Male
|
108 Participants
n=246 Participants • Not all parents completed sex data entry in the baseline survey.
|
17 Participants
n=220 Participants • Not all parents completed sex data entry in the baseline survey.
|
0 Participants
n=24 Participants • Not all parents completed sex data entry in the baseline survey.
|
117 Participants
n=244 Participants • Not all parents completed sex data entry in the baseline survey.
|
18 Participants
n=227 Participants • Not all parents completed sex data entry in the baseline survey.
|
0 Participants
n=27 Participants • Not all parents completed sex data entry in the baseline survey.
|
260 Participants
n=988 Participants • Not all parents completed sex data entry in the baseline survey.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=246 Participants
|
9 Participants
n=248 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=244 Participants
|
5 Participants
n=245 Participants
|
1 Participants
n=27 Participants
|
29 Participants
n=1034 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=246 Participants
|
28 Participants
n=248 Participants
|
11 Participants
n=24 Participants
|
19 Participants
n=244 Participants
|
21 Participants
n=245 Participants
|
10 Participants
n=27 Participants
|
115 Participants
n=1034 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=246 Participants
|
1 Participants
n=248 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=244 Participants
|
2 Participants
n=245 Participants
|
0 Participants
n=27 Participants
|
6 Participants
n=1034 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=246 Participants
|
6 Participants
n=248 Participants
|
1 Participants
n=24 Participants
|
8 Participants
n=244 Participants
|
8 Participants
n=245 Participants
|
1 Participants
n=27 Participants
|
32 Participants
n=1034 Participants
|
|
Race (NIH/OMB)
White
|
106 Participants
n=246 Participants
|
102 Participants
n=248 Participants
|
5 Participants
n=24 Participants
|
105 Participants
n=244 Participants
|
106 Participants
n=245 Participants
|
9 Participants
n=27 Participants
|
433 Participants
n=1034 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=246 Participants
|
5 Participants
n=248 Participants
|
0 Participants
n=24 Participants
|
12 Participants
n=244 Participants
|
2 Participants
n=245 Participants
|
1 Participants
n=27 Participants
|
33 Participants
n=1034 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
84 Participants
n=246 Participants
|
97 Participants
n=248 Participants
|
6 Participants
n=24 Participants
|
93 Participants
n=244 Participants
|
101 Participants
n=245 Participants
|
5 Participants
n=27 Participants
|
386 Participants
n=1034 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
184 Participants
n=246 Participants
|
180 Participants
n=248 Participants
|
11 Participants
n=24 Participants
|
197 Participants
n=244 Participants
|
193 Participants
n=245 Participants
|
12 Participants
n=27 Participants
|
777 Participants
n=1034 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=246 Participants
|
39 Participants
n=248 Participants
|
13 Participants
n=24 Participants
|
32 Participants
n=244 Participants
|
34 Participants
n=245 Participants
|
15 Participants
n=27 Participants
|
170 Participants
n=1034 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=246 Participants
|
29 Participants
n=248 Participants
|
0 Participants
n=24 Participants
|
15 Participants
n=244 Participants
|
18 Participants
n=245 Participants
|
0 Participants
n=27 Participants
|
87 Participants
n=1034 Participants
|
|
Region of Enrollment
United States
|
246 participants
n=246 Participants
|
248 participants
n=248 Participants
|
24 participants
n=24 Participants
|
244 participants
n=244 Participants
|
245 participants
n=245 Participants
|
27 participants
n=27 Participants
|
1034 participants
n=1034 Participants
|
|
BMI Z-score
|
0.63 z-score
STANDARD_DEVIATION 0.99 • n=244 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
—
|
—
|
0.71 z-score
STANDARD_DEVIATION 1.07 • n=240 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
—
|
—
|
0.67 z-score
STANDARD_DEVIATION 1.03 • n=484 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
|
Beverage kcal at childcare
|
48.88 kcal
n=211 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
—
|
—
|
49.35 kcal
n=220 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
—
|
—
|
49.11 kcal
n=431 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
|
Beverage kcal at home
|
95.23 kcal
n=219 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
—
|
—
|
105.84 kcal
n=221 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
—
|
—
|
100.67 kcal
n=440 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
|
Water ounces at childcare
|
4.25 Ounces
n=211 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
—
|
—
|
4.19 Ounces
n=220 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
—
|
—
|
4.25 Ounces
n=431 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
|
Water ounces at home (ASA24)
|
8.47 Ounces
n=219 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
—
|
—
|
8.47 Ounces
n=221 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
—
|
—
|
8.47 Ounces
n=440 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
|
SSB ounces at home (BEVQ-PS)
|
2.10 Ounces
n=220 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
—
|
—
|
1.50 Ounces
n=212 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
—
|
—
|
1.79 Ounces
n=432 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
|
Water ounces at home (BEVQ-PS)
|
13.57 Ounces
n=219 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
—
|
—
|
15.00 Ounces
n=212 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
—
|
—
|
14.68 Ounces
n=431 Participants • This characteristic was collected from children only; children with available data are included in the analysis.
|
PRIMARY outcome
Timeframe: Baseline, 6-months, and 10-months after the start of the study.Population: This outcome was collected for children only. Missing data were imputed.
Trained research staff measure children's 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 to quantify how far a child's anthropometry measurement deviates from the median of a reference population. The score is calculated using the sex, age, weight, and height of the participant, and is based on growth references for children. A z-score of 0 reflects the 50th percentile (the median) of the reference growth charts. For example, a z-score of 1.5 indicates a child is 1.5 standard deviation units above the reference median, whereas a z-score of -1.5 means a child is 1.5 below it, adjusting for childhood BMI distributions.
Outcome measures
| Measure |
Healthy Beverage Access and Promotion - Children
n=246 Participants
Intervention group receives supports to increase access to water at mealtimes and throughout the day, individualized education to help families set healthy drinks goals, and a curricula focused on increasing intake of water and healthy beverages.
|
Control Group - Children
n=244 Participants
Participants receive usual care during the study, and are provided intervention materials at study conclusion.
|
|---|---|---|
|
Change in BMI Z-score
Baseline
|
.64 z-score
Standard Error .07
|
.72 z-score
Standard Error .07
|
|
Change in BMI Z-score
Month 6
|
.68 z-score
Standard Error .07
|
.78 z-score
Standard Error .07
|
|
Change in BMI Z-score
Month 10
|
.69 z-score
Standard Error .07
|
.76 z-score
Standard Error .07
|
SECONDARY outcome
Timeframe: Baseline and 10-months after the start of the study.Population: This outcome was collected for children only. Missing data were imputed.
Trained research staff conduct two day-long plate waste measurements per center. Beverages are weighed before and after intake.
Outcome measures
| Measure |
Healthy Beverage Access and Promotion - Children
n=246 Participants
Intervention group receives supports to increase access to water at mealtimes and throughout the day, individualized education to help families set healthy drinks goals, and a curricula focused on increasing intake of water and healthy beverages.
|
Control Group - Children
n=244 Participants
Participants receive usual care during the study, and are provided intervention materials at study conclusion.
|
|---|---|---|
|
Total Caloric Intake From Beverages at Childcare Centers
Beverage - Baseline
|
3.43 log kcal/day
Standard Error 0.12
|
3.47 log kcal/day
Standard Error 0.12
|
|
Total Caloric Intake From Beverages at Childcare Centers
Beverage - Month 10
|
3.14 log kcal/day
Standard Error 0.13
|
3.46 log kcal/day
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline and 10-months after the start of the study.Population: This outcome was collected for children only. Missing data were imputed.
Calorie content of beverages consumed outside of childcare centers derived from ASA24® nutrient database.
Outcome measures
| Measure |
Healthy Beverage Access and Promotion - Children
n=246 Participants
Intervention group receives supports to increase access to water at mealtimes and throughout the day, individualized education to help families set healthy drinks goals, and a curricula focused on increasing intake of water and healthy beverages.
|
Control Group - Children
n=244 Participants
Participants receive usual care during the study, and are provided intervention materials at study conclusion.
|
|---|---|---|
|
Total Caloric Intake From Beverages Outside of Childcare Centers
Baseline
|
3.96 log kcal/day
Standard Error 0.13
|
4.02 log kcal/day
Standard Error 0.13
|
|
Total Caloric Intake From Beverages Outside of Childcare Centers
Month 10
|
3.50 log kcal/day
Standard Error 0.14
|
4.04 log kcal/day
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline, and 10-months after the start of the study.Population: This outcome was collected for children only. Missing data were imputed.
Trained research staff conduct two day-long plate waste measurements, per center. Water is weighed before and after intake.
Outcome measures
| Measure |
Healthy Beverage Access and Promotion - Children
n=246 Participants
Intervention group receives supports to increase access to water at mealtimes and throughout the day, individualized education to help families set healthy drinks goals, and a curricula focused on increasing intake of water and healthy beverages.
|
Control Group - Children
n=244 Participants
Participants receive usual care during the study, and are provided intervention materials at study conclusion.
|
|---|---|---|
|
Total Water Intake From Beverages at Childcare Centers
Baseline
|
1.58 log ounces/day
Standard Error 0.07
|
1.63 log ounces/day
Standard Error 0.07
|
|
Total Water Intake From Beverages at Childcare Centers
Month 10
|
1.72 log ounces/day
Standard Error 0.08
|
1.60 log ounces/day
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline, and 10-months after the start of the study.Population: This outcome was collected for children only. Missing data were imputed.
Water intake outside of childcare centers derived from ASA24® nutrient database.
Outcome measures
| Measure |
Healthy Beverage Access and Promotion - Children
n=246 Participants
Intervention group receives supports to increase access to water at mealtimes and throughout the day, individualized education to help families set healthy drinks goals, and a curricula focused on increasing intake of water and healthy beverages.
|
Control Group - Children
n=244 Participants
Participants receive usual care during the study, and are provided intervention materials at study conclusion.
|
|---|---|---|
|
Total Water Intake Outside of Childcare Centers
Baseline
|
2.11 log ounces/day
Standard Error 0.06
|
2.08 log ounces/day
Standard Error 0.06
|
|
Total Water Intake Outside of Childcare Centers
Month 10
|
2.43 log ounces/day
Standard Error 0.06
|
2.15 log ounces/day
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline, 6-months, and 10-months after the start of the study.Population: This outcome was collected for children only. Missing data were imputed.
Beverage intake frequency questionnaire (BEVQ PS) used to calculate past-week frequency of beverages consumed (ounces/day).
Outcome measures
| Measure |
Healthy Beverage Access and Promotion - Children
n=246 Participants
Intervention group receives supports to increase access to water at mealtimes and throughout the day, individualized education to help families set healthy drinks goals, and a curricula focused on increasing intake of water and healthy beverages.
|
Control Group - Children
n=244 Participants
Participants receive usual care during the study, and are provided intervention materials at study conclusion.
|
|---|---|---|
|
Beverage Intake
Water - Month 10
|
2.53 log ounces/day
Standard Error 0.07
|
2.40 log ounces/day
Standard Error 0.07
|
|
Beverage Intake
SSB - Baseline
|
1.15 log ounces/day
Standard Error 0.07
|
1.15 log ounces/day
Standard Error 0.07
|
|
Beverage Intake
SSB - Month 6
|
0.80 log ounces/day
Standard Error 0.07
|
0.99 log ounces/day
Standard Error 0.07
|
|
Beverage Intake
SSB - Month 10
|
0.73 log ounces/day
Standard Error 0.07
|
0.94 log ounces/day
Standard Error 0.07
|
|
Beverage Intake
Water - Month 6
|
2.57 log ounces/day
Standard Error 0.07
|
2.50 log ounces/day
Standard Error 0.07
|
|
Beverage Intake
Water - Baseline
|
2.54 log ounces/day
Standard Error 0.07
|
2.50 log ounces/day
Standard Error 0.07
|
Adverse Events
Healthy Beverage Access and Promotion - Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Beverage Access and Promotion - Parents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Beverage Access and Promotion - Providers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group - Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group - Parents
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Control Group - Providers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Healthy Beverage Access and Promotion - Children
n=246 participants at risk
Intervention group receives BPA-free self-serve pitchers and cups for serving water at mealtimes, individualized education to help families set healthy drinks goals for their family, and a curricula focused on increasing intake of water and healthy beverages.
|
Healthy Beverage Access and Promotion - Parents
n=248 participants at risk
Intervention group receives BPA-free self-serve pitchers and cups for serving water at mealtimes, individualized education to help families set healthy drinks goals for their family, and a curricula focused on increasing intake of water and healthy beverages.
|
Healthy Beverage Access and Promotion - Providers
n=24 participants at risk
Intervention group receives BPA-free self-serve pitchers and cups for serving water at mealtimes, individualized education to help families set healthy drinks goals for their family, and a curricula focused on increasing intake of water and healthy beverages.
|
Control Group - Children
n=244 participants at risk
Participants receive usual care during the study, and are provided intervention materials at study conclusion.
|
Control Group - Parents
n=245 participants at risk
Participants receive usual care during the study, and are provided intervention materials at study conclusion.
|
Control Group - Providers
n=27 participants at risk
Participants receive usual care during the study, and are provided intervention materials at study conclusion.
|
|---|---|---|---|---|---|---|
|
General disorders
Death
|
0.00%
0/246 • Up to 1 year
|
0.00%
0/248 • Up to 1 year
|
0.00%
0/24 • Up to 1 year
|
0.00%
0/244 • Up to 1 year
|
0.41%
1/245 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place