Trial Outcomes & Findings for Addressing Obesity in Early Care and Education Settings (NCT NCT04140032)
NCT ID: NCT04140032
Last Updated: 2025-06-12
Results Overview
Height and weight of preschool children were measured by trained research staff. These data were used to calculate children's body mass index (BMI) scores. The BMI Z-score is a measure calculated from a child's height and weight that indicates how a child's BMI compares with the BMI of a reference population of U.S. children of the same age and sex. The reference population is based on Center for Disease Control and Prevention (CDC) pediatric growth charts and the BMI Z-score is calculated using a CDC-provided computer program. A Z-score of 0 corresponds to the mean BMI of the reference population. A Z-score of +1 corresponds to a BMI that is one standard deviation above the mean of the reference population, and a Z-score of -1 represents a BMI that is one standard deviation below the mean of the reference population. When used as a measure of obesity risk, a lower Z-score is considered a better outcome.
COMPLETED
NA
1136 participants
Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later)
2025-06-12
Participant Flow
68 preschools were screened
51 preschools were randomized; 3 withdrew before baseline data collection. All students in a preschool were assigned to the same group. The study used an open cohort design in which all students who provided data at baseline and/or follow-up were included. Note: We use the 1136 preschool children included in the primary outcome (BMI z-score)
Unit of analysis: Preschool
Participant milestones
| Measure |
Intervention
Preschools participated in the A-B-C Healthy Me/Soy Saludable multi-component nutrition and physical activity preschool intervention.
|
Control
Preschools continued with "usual care" practices. Control group preschools received intervention materials and accompanying instructions after follow-up measures were collected for each cohort.
|
|---|---|---|
|
Overall Study
STARTED
|
618 25
|
518 23
|
|
Overall Study
COMPLETED
|
618 25
|
518 23
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Addressing Obesity in Early Care and Education Settings
Baseline characteristics by cohort
| Measure |
Intervention
n=25 Preschools
Preschools participated in the A-B-C Healthy Me/Soy Saludable multi-component nutrition and physical activity preschool intervention.
|
Control
n=22 Preschools
Preschools continued with "usual care" practices. Control group preschools received intervention materials and accompanying instructions after follow-up measures were collected for each cohort.
|
Total
n=47 Preschools
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age, Continuous
|
45.3 Months
STANDARD_DEVIATION 9.2 • n=5 Participants
|
43.7 Months
STANDARD_DEVIATION 9.6 • n=7 Participants
|
44.6 Months
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
289 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
513 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
312 Participants
n=5 Participants
|
277 Participants
n=7 Participants
|
589 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
237 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
432 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
195 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
373 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
169 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
96 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
121 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
340 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
616 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
601 participants
n=5 Participants
|
501 participants
n=7 Participants
|
1102 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later)Population: All participants for whom valid height, weight, age, and sex were collected at baseline and/or follow-up.
Height and weight of preschool children were measured by trained research staff. These data were used to calculate children's body mass index (BMI) scores. The BMI Z-score is a measure calculated from a child's height and weight that indicates how a child's BMI compares with the BMI of a reference population of U.S. children of the same age and sex. The reference population is based on Center for Disease Control and Prevention (CDC) pediatric growth charts and the BMI Z-score is calculated using a CDC-provided computer program. A Z-score of 0 corresponds to the mean BMI of the reference population. A Z-score of +1 corresponds to a BMI that is one standard deviation above the mean of the reference population, and a Z-score of -1 represents a BMI that is one standard deviation below the mean of the reference population. When used as a measure of obesity risk, a lower Z-score is considered a better outcome.
Outcome measures
| Measure |
Intervention
n=601 Participants
Preschools participated in the A-B-C Healthy Me/Soy Saludable multi-component nutrition and physical activity preschool intervention.
|
Control
n=501 Participants
Preschools continued with "usual care" practices. Control group preschools received intervention materials and accompanying instructions after follow-up measures were collected for each cohort.
|
|---|---|---|
|
Child BMI Z-score
Baseline
|
0.40 Z-score
Standard Deviation 1.07
|
0.43 Z-score
Standard Deviation 1.13
|
|
Child BMI Z-score
Follow-up
|
0.31 Z-score
Standard Deviation 1.14
|
0.48 Z-score
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later)Population: All participants with a valid response to the survey question at baseline and/or follow-up.
Parents completed surveys regarding children's physical activity and nutrition. For frequency of fruit consumption, the following question was asked: How often does your child eat... fruit? Include fresh, frozen, or canned fruit. DO NOT include juices. The response is dichotomized as at least once a day versus less than once a day.
Outcome measures
| Measure |
Intervention
n=425 Participants
Preschools participated in the A-B-C Healthy Me/Soy Saludable multi-component nutrition and physical activity preschool intervention.
|
Control
n=386 Participants
Preschools continued with "usual care" practices. Control group preschools received intervention materials and accompanying instructions after follow-up measures were collected for each cohort.
|
|---|---|---|
|
Percentage of Children Who Eat Fruit Once a Day
Baseline
|
82 Percent of children who eat fruits
|
76 Percent of children who eat fruits
|
|
Percentage of Children Who Eat Fruit Once a Day
Follow-up
|
86 Percent of children who eat fruits
|
82 Percent of children who eat fruits
|
SECONDARY outcome
Timeframe: Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later)Population: All participants with a valid response to the survey question of interest at baseline and/or follow-up.
Parents completed surveys regarding children's physical activity and nutrition. For frequency of physical activity, the following question was asked: During the past 7 days, on how many days was your child physically active for a total of at least 60 minutes per day?
Outcome measures
| Measure |
Intervention
n=420 Participants
Preschools participated in the A-B-C Healthy Me/Soy Saludable multi-component nutrition and physical activity preschool intervention.
|
Control
n=379 Participants
Preschools continued with "usual care" practices. Control group preschools received intervention materials and accompanying instructions after follow-up measures were collected for each cohort.
|
|---|---|---|
|
Frequency of Physical Activity
Baseline
|
4.9 days
Standard Deviation 2.1
|
4.8 days
Standard Deviation 2.1
|
|
Frequency of Physical Activity
Follow-up
|
5.2 days
Standard Deviation 2.0
|
5.4 days
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 4 weeks post interventionTeacher nutrition will be measured via self-report of dietary intake.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeks post interventionTeacher physical activity will be measured via self-report of physical activity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeks post interventionNutrition and physical activity policies of the preschool will be assessed via in-person all day observations of one preschool classroom per site. Trained research staff will conduct these observations during an on-site visit to the center. Additionally, preschool site directors will complete a nutrition and physical activity policy and practice survey to assess center nutrition and physical activity policies.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later)Population: All participants with a valid response to the survey question at baseline and/or follow-up.
Parents completed surveys regarding children's physical activity and nutrition. For frequency of vegetable consumption, the following question was asked: How often does your child eat... vegetables? DO NOT count potatoes, or beans. The response is dichotomized as at least once a day versus less than once a day.
Outcome measures
| Measure |
Intervention
n=424 Participants
Preschools participated in the A-B-C Healthy Me/Soy Saludable multi-component nutrition and physical activity preschool intervention.
|
Control
n=386 Participants
Preschools continued with "usual care" practices. Control group preschools received intervention materials and accompanying instructions after follow-up measures were collected for each cohort.
|
|---|---|---|
|
Percentage of Children Who Eat Vegetables Once a Day
Baseline
|
61 Percentage children who eat vegetables
|
61 Percentage children who eat vegetables
|
|
Percentage of Children Who Eat Vegetables Once a Day
Follow-up
|
69 Percentage children who eat vegetables
|
69 Percentage children who eat vegetables
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place