ObesityNCT04140032
Addressing Obesity in Early Care and Education Settings
A study of Obesity, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Childhood obesity is a national epidemic that disproportionately burdens low income and ethnic minority populations. By preschool, nearly one-third of low income children are already overweight or obese, setting the stage for adverse health outcomes over their life course. Read more about this study
- Who is it for?
- Ages 30 months and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,136 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 31 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Preschool Sites:
- Must be in CCRC network of preschools
- Have 20 or more preschool aged children (2.5-5 years old) in attendance at site
- Children must eat at least one meal on-site per school day
- Must have at least one preschool classroom
- Providers (Teachers and Preschool Site Directors):
Show all 12Show fewer
- Teachers must teach a preschool class at participating preschool
- Be able to provide informed consent
- Parents and Children:
- Child must be 2.5-5 years old and enrolled in the participating preschool
- Child primary caregiver must have at least one child 2.5-5 years old that is enrolled in the preschool
- Child primary care giver must be able to read and write in English or Spanish
Who cannot join
- Preschool Sites:
- Have less than 20 preschool aged children (2.5-5 years old) enrolled.
- Do not have a preschool classroom
- Are not in the CCRC network
- Preschools that are based in a family-home or serve special needs children exclusively
- Children do not eat at least one meal on-site per school day
Show all 11Show fewer
- Providers (Teachers and Preschool Site Directors):
- -Teachers not currently teaching a preschool class
- Parents and Children:
- Child primary care giver unable to read or write in English or Spanish
- Primary care giver who does not have a child currently enrolled in a preschool class
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Fielding School of Public Health
Los Angeles, California, 90095
About this study
Childhood obesity is a national epidemic that disproportionately burdens low income and ethnic minority populations. By preschool, nearly one-third of low income children are already overweight or obese, setting the stage for adverse health outcomes over their life course. Evidence is mounting that individual-focused, single-component interventions fail to produce long-term population-level changes in obesity-related outcomes. Evidence increasingly supports creating entire environments (e.g., schools) in which the healthy choice is the default option.
The investigators will conduct a pragmatic cluster randomized trial to evaluate the effectiveness of a multilevel (organization, teacher, parent, child) intervention to support healthy eating and physical activity in preschools. The study is being conducted in partnership with Child Care Resource Center (CCRC), a non-profit organization dedicated to ensuring that all children receive high quality preschool experiences. The investigators will randomly assign 60 preschool sites (stratified by size), located in underserved areas of Los Angeles, to the intervention or a usual practice control conditions.
The investigators will evaluate the effectiveness of the intervention on child BMI z-scores (primary outcome) and parent-reported child nutrition and physical activity (secondary outcomes). The investigators will systematically examine the implementation process to understand factors that may facilitate or hinder intervention uptake and success. The findings from this work will be critical for informing future dissemination efforts.
Read the detailed description
This study involves a 2-group design with stratified cluster randomization at the level of the preschool. The investigators will recruit 60 preschools from LA County's most vulnerable communities, stratified by size (large, small). The investigators will randomly select pairs of schools from each stratum and randomly assign one member of each pair to the intervention or control conditions. Given the 10-month instructional year (Sept. 1-June 30), preschools will be recruited in three cohorts over three instructional years (~20 schools per cohort). To control for time trends in outcomes, the randomization protocol will be implemented independently within each cohort. Baseline data collection, conducted in the first six weeks of the school year, will include surveys (site directors, teachers, parents), anthropometric measures (children), preschool policy reviews and direct observation in preschools including child-level eating behavior and physical activity.
The multilevel intervention will be initiated immediately following baseline data collection and will consist of 1) establishment of organizational policies to support healthy nutrition and physical activity, 2) integration of nutrition and physical activity content into curricula 3) supports for teachers and staff to model healthy behavior, and 4) engagement of parents as partners in implementing healthy policies in preschool and at home. Implementation measures will be collected throughout the project period. Follow-up data collection, in the last four-six weeks of the school year, will mirror baseline data collection.
Study Hypotheses:
- Children at intervention schools will gain less weight relative to height gains compared to children at control schools, resulting in lower mean BMI z-scores at follow-up (effectiveness). Outcomes will be assessed in the overall sample and among the subset of children who are overweight or obese at baseline.
- Intervention preschools will have greater implementation of healthy nutrition and physical activity policies and practices at follow-up compared to control preschools.
The primary effectiveness outcome will be child age-and sex-adjusted BMI z-score. The investigators will obtain baseline data on 1,630 children, 815 per condition, 60 preschool site directors and approximately 135 teachers. Estimating 80% child retention at follow-up, the investigators anticipate having follow-up data on 1,304 children, 652 per study arm. Data will also be collected from the parents of participating children at baseline and follow-up.
- Conditions
- Obesity
- Being tested
- Multi-level preschool obesity control intervention
- Keywords
- obesity, nutrition, physical activity, preschool, child care centers, policy-system-environment intervention
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-level preschool obesity control interventionBehavioural
The multi-level intervention is a preschool-based program that integrates healthy nutrition and physical activity policies and practices into preschool operations via the Sesame Street Healthy Habits for Life curriculum. In addition to the curriculum, the intervention includes coaching sessions to enhance teacher lesson planning to routinely include nutrition and physical activity; as well as assist preschool site directors with implementing policy changes and parent engagement sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Centers in the group will participate in the A-B-C Healthy Me/Soy Saludable multi- component nutrition and physical activity preschool intervention. Receives: Behavioral: Multi-level preschool obesity control intervention |
| Control group | No intervention | Preschools in the group will continue with "usual care" practices. Control group preschools will receive intervention materials and accompanying instructions after follow-up measures are collected for each cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child BMI Z-score
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.
Measured: Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later)
Secondary outcomes (6)
Percentage of Children Who Eat Fruit Once a Day
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.
Measured: Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later)
Frequency of Physical Activity
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?
Measured: Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later)
Teacher Nutrition Behaviors
Teacher nutrition will be measured via self-report of dietary intake.
Measured: 4 weeks post intervention
Teacher Physical Activity Behaviors
Teacher physical activity will be measured via self-report of physical activity.
Measured: 4 weeks post intervention
Nutrition and Physical Activity Policies and Practices at Preschool Site Level
Nutrition 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.
Measured: 4 weeks post intervention
Percentage of Children Who Eat Vegetables Once a Day
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.
Measured: Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start1 Oct 2019
- Primary completion1 Jul 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roshan Bastani, University of California, Los Angeles
- Investigators
- Roshan Bastani, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140032
- Sponsor's protocol ID
- 19-000570
- Status last verified
- Jun 2025
- First submitted
- 18 Oct 2019
- Last updated
- 12 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Obesity in Early Care and Education Settings
- ClinicalTrials.gov ID
- NCT04140032
- Acronym / sponsor ID
- 19-000570
- Conditions
- Obesity
- Keywords
- obesity, nutrition, physical activity, preschool, child care centers, policy-system-environment intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,136 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 25 Oct 2019 (actual)
- Results
- Posted 12 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Childhood obesity is a national epidemic that disproportionately burdens low income and ethnic minority populations. By preschool, nearly one-third of low income children are already overweight or obese, setting the stage for adverse health outcomes over their life course. Evidence is mounting that individual-focused, single-component interventions fail to produce long-term population-level changes in obesity-related outcomes. Evidence increasingly supports creating entire environments (e.g., schools) in which the healthy choice is the default option.
The investigators will conduct a pragmatic cluster randomized trial to evaluate the effectiveness of a multilevel (organization, teacher, parent, child) intervention to support healthy eating and physical activity in preschools. The study is being conducted in partnership with Child Care Resource Center (CCRC), a non-profit organization dedicated to ensuring that all children receive high quality preschool experiences. The investigators will randomly assign 60 preschool sites (stratified by size), located in underserved areas of Los Angeles, to the intervention or a usual practice control conditions.
The investigators will evaluate the effectiveness of the intervention on child BMI z-scores (primary outcome) and parent-reported child nutrition and physical activity (secondary outcomes). The investigators will systematically examine the implementation process to understand factors that may facilitate or hinder intervention uptake and success. The findings from this work will be critical for informing future dissemination efforts.
Detailed description
This study involves a 2-group design with stratified cluster randomization at the level of the preschool. The investigators will recruit 60 preschools from LA County's most vulnerable communities, stratified by size (large, small). The investigators will randomly select pairs of schools from each stratum and randomly assign one member of each pair to the intervention or control conditions. Given the 10-month instructional year (Sept. 1-June 30), preschools will be recruited in three cohorts over three instructional years (~20 schools per cohort). To control for time trends in outcomes, the randomization protocol will be implemented independently within each cohort. Baseline data collection, conducted in the first six weeks of the school year, will include surveys (site directors, teachers, parents), anthropometric measures (children), preschool policy reviews and direct observation in preschools including child-level eating behavior and physical activity.
The multilevel intervention will be initiated immediately following baseline data collection and will consist of 1) establishment of organizational policies to support healthy nutrition and physical activity, 2) integration of nutrition and physical activity content into curricula 3) supports for teachers and staff to model healthy behavior, and 4) engagement of parents as partners in implementing healthy policies in preschool and at home. Implementation measures will be collected throughout the project period. Follow-up data collection, in the last four-six weeks of the school year, will mirror baseline data collection.
Study Hypotheses:
- Children at intervention schools will gain less weight relative to height gains compared to children at control schools, resulting in lower mean BMI z-scores at follow-up (effectiveness). Outcomes will be assessed in the overall sample and among the subset of children who are overweight or obese at baseline.
- Intervention preschools will have greater implementation of healthy nutrition and physical activity policies and practices at follow-up compared to control preschools.
The primary effectiveness outcome will be child age-and sex-adjusted BMI z-score. The investigators will obtain baseline data on 1,630 children, 815 per condition, 60 preschool site directors and approximately 135 teachers. Estimating 80% child retention at follow-up, the investigators anticipate having follow-up data on 1,304 children, 652 per study arm. Data will also be collected from the parents of participating children at baseline and follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Multi-level preschool obesity control interventionCenters in the group will participate in the A-B-C Healthy Me/Soy Saludable multi- component nutrition and physical activity preschool intervention. |
| Control group | No intervention | –Preschools in the group will continue with "usual care" practices. Control group preschools will receive intervention materials and accompanying instructions after follow-up measures are collected for each cohort. |
Who may qualify
- Ages
- 30 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Must be in CCRC network of preschools
- Have 20 or more preschool aged children (2.5-5 years old) in attendance at site
- Children must eat at least one meal on-site per school day
- Must have at least one preschool classroom
- Teachers must teach a preschool class at participating preschool
Key exclusion criteria (11 listed)
- Have less than 20 preschool aged children (2.5-5 years old) enrolled.
- Do not have a preschool classroom
- Are not in the CCRC network
- Preschools that are based in a family-home or serve special needs children exclusively
- Children do not eat at least one meal on-site per school day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-level preschool obesity control interventionThe multi-level intervention is a preschool-based program that integrates healthy nutrition and physical activity policies and practices into preschool operations via the Sesame Street Healthy Habits for Life curriculum. In addition to the curriculum, the intervention includes coaching sessions to enhance teacher lesson planning to routinely include nutrition and physical activity; as well as assist preschool site directors with implementing policy changes and parent engagement sessions. | Behavioural | Intervention group |
Primary outcome
Child BMI Z-score
Time frame: Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later)
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.
6 secondary outcomes
Percentage of Children Who Eat Fruit Once a Day
Time frame: Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later)
Frequency of Physical Activity
Time frame: Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later)
Teacher Nutrition Behaviors
Time frame: 4 weeks post intervention
Teacher Physical Activity Behaviors
Time frame: 4 weeks post intervention
Nutrition and Physical Activity Policies and Practices at Preschool Site Level
Time frame: 4 weeks post intervention
Percentage of Children Who Eat Vegetables Once a Day
Time frame: Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roshan Bastani, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Obesity, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child BMI Z-score (time frame: Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.