Dietary IntakesIMPLEMENTNCT07874295
Implementing Modified Practices to Leverage Evidence for Movement, Engagement, and Nutrition Topics in Early Childcare and Education
A study testing Boston Healthy Child Care Initiative in people with Dietary Intakes and Physical Activity, run by Harvard School of Public Health (HSPH) at 1 site in United States.
Trial summary
The goal of this cluster-randomized, controlled trial is to learn if a professional development program for childcare educators, called the Boston Healthy Child Care Initiative, can help improve the nutritional quality of meals/snacks served and the availability of physical activity opportunities in childcare… Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Intakes, Physical Activity, Child Care
- What is being tested?
- Boston Healthy Child Care Initiative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 2-5 years old
- Attends early care and education program located in the city of Boston
- At least one parent/guardian reads English or Spanish
Who cannot join
- Ages <2 or >5 years
- Does not attend early care and education
- Attends a program outside of the city of Boston
- Parent/guardian cannot read English or Spanish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Harvard T.H. Chan School of Public Health
Boston, Massachusetts, 02115
Rebecca Mozaffarian, MPH, 617-433-7448, hprc.research@hsph.harvard.edu
About this study
The goal of this cluster-randomized, controlled trial is to learn if a professional development program for childcare educators, called the Boston Healthy Child Care Initiative, can help improve the nutritional quality of meals/snacks served and the availability of physical activity opportunities in childcare programs, and also to learn if this results in improved diet quality and physical activity for young children who attend childcare, especially in under-resourced settings. The main questions it aims to answer are:
Do childcare programs that receive professional development through the Boston Healthy Child Care Initiative improve the nutritional quality of the meals they serve, as measured by the Healthy Eating Index (HEI-2020), and do they also provide more physical activity opportunities to young children throughout the day? Do young children (ages 2-5 years) attending childcare programs that receive the Boston Healthy Child Care Initiative eat more nutritious foods/beverages (as measured by the HEI-2020) and engage in less sedentary time at childcare?
Read more
Researchers will compare a group of childcare programs who participate in the Boston Healthy Child Care Initiative, and a sample of children who attend those programs, to a similar group of childcare programs who do not participate to see if the quality of meals served, the amounts of physical activity opportunities scheduled, young children's dietary quality, and the minutes/day spent in physical activity increase from before to after the Boston Healthy Child Care Initiative.
Childcare educator participants will:
- Complete the Boston Healthy Child Care Initiative professional development program (for the intervention group only)
- Share copies of menus, schedules, and written policies about nutrition and physical activity in the childcare program
Child participants will:
- Wear ActiGraph wGT3X-BT accelerometers for two days while at childcare to measure physical activity levels. They will do this for two days each at baseline, midline, and follow-up after the initiative concludes.
- Be observed during mealtimes by trained researchers to visually estimate how much they consume at meals and snacks in childcare.
- Conditions
- Dietary Intakes, Physical Activity, Child Care, Early Education, Children Aged 3-5 Years, Toddlers
- Being tested
- Boston Healthy Child Care Initiative
- Keywords
- Child care, Implementation science, Dietary intakes, Early care and education, Physical Activity, Professional development, Policy, systems, and environmental change, Evidence-based intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston Healthy Child Care InitiativeOther
The Boston Healthy Child Care Initiative is a professional development and peer-networking program offered by the Boston Public Health Commission for ECE programs in Boston. Building on the evidence-based Go NAP SACC program, it helps ECE educators set goals and create action plans to implement policies and practices that support healthy eating and physical activity for young children. Facilitators, in English and Spanish, share practical, real-world advice and teach skills for how to boost nutrition and physical activity at childcare, and educators connect with one another to share their own tips and help each other problem-solve. BHCCI covers three areas: Nutrition in the First Five Years, Physical Activity Learning Session, and Farm-to-ECE. Programs also receive stipends to support healthy changes.
| Study group | Role | What they receive |
|---|---|---|
| Boston Healthy Child Care Initiative - Intervention | Experimental | Childcare programs assigned to the intervention group will participate in the Boston Healthy Child Care Initiative's professional development program from January- November 2027. Receives: Other: Boston Healthy Child Care Initiative |
| Control group (delayed intervention) | No intervention | Childcare programs assigned to the control group will receive no intervention during 2027 while the intervention group participates in the Boston Healthy Child Care Initiative. After follow-up data collection is completed, however, this group will be offered the opportunity to participate in the Boston Healthy Child Care Initiative in 2028. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline to post-intervention in Healthy Eating Index (2020) score for young children's dietary intake while attending childcare.
The Healthy Eating Index (2020) measures the extent to which dietary intake aligns with standards set by the Dietary Guidelines for Americans (2020). The index ranges from 0-100, with higher scores representing more alignment with the Dietary Guidelines for Americans.
Measured: 12 months
Secondary outcomes (6)
Mean change from baseline to post-intervention in minutes per day that 2-5 year old children spend in sedentary time while attending childcare
Measured: 12 months
Mean change from baseline to post-intervention in the percentage of time in childcare that 2-5 year old children spend in sedentary time
Measured: 12 months
Mean change from baseline to post-intervention in number of best practice nutrition and physical activity policies adopted at the childcare program
Measured: 12 months
Mean change from baseline to post-intervention in average dynamic acceleration per day among 2-5 children while attending childcare
Average dynamic acceleration is the component of acceleration measured by accelerometers that attributable to movement by correcting for acceleration due to gravity. This outcome enables comparison with other studies.
Measured: 12 months
Mean change from baseline to post-intervention in accelerometer-measured intensity gradient per day among 2-5 children while attending childcare
The intensity gradient incorporates information on the intensity of physical activities across the day into a single metric.
Measured: 12 months
Mean change from baseline to post-intervention in cup-equivalents of fruits and vegetables consumed per day at childcare among 2-5 year old children
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary IntakesStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Erica Kenney, Harvard School of Public Health (HSPH)
- Investigators
- Erica L Kenney, ScD, MPH, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874295
- Sponsor's protocol ID
- IRB26-1104
- Other IDs
- U48DP006785
- Acronym
- IMPLEMENT
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data on child participants' changes in dietary intake and physical activity, along with data on child care programs' policy scores, will be made available. Participants' identifying information will be removed so there is no way of tracing the identity of children or childcare programs. Data will be reviewed prior to release to ensure that confidentiality is protected.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Modified Practices to Leverage Evidence for Movement, Engagement, and Nutrition Topics in Early Childcare and Education
- ClinicalTrials.gov ID
- NCT07874295
- Acronym / sponsor ID
- IMPLEMENT / IRB26-1104
- Conditions
- Dietary Intakes, Physical Activity, Child Care, Early Education, Children Aged 3-5 Years, Toddlers
- Keywords
- Child care, Implementation science, Dietary intakes, Early care and education, Physical Activity, Professional development, Policy, systems, and environmental change, Evidence-based intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this cluster-randomized, controlled trial is to learn if a professional development program for childcare educators, called the Boston Healthy Child Care Initiative, can help improve the nutritional quality of meals/snacks served and the availability of physical activity opportunities in childcare programs, and also to learn if this results in improved diet quality and physical activity for young children who attend childcare, especially in under-resourced settings. The main questions it aims to answer are:
Do childcare programs that receive professional development through the Boston Healthy Child Care Initiative improve the nutritional quality of the meals they serve, as measured by the Healthy Eating Index (HEI-2020), and do they also provide more physical activity opportunities to young children throughout the day? Do young children (ages 2-5 years) attending childcare programs that receive the Boston Healthy Child Care Initiative eat more nutritious foods/beverages (as measured by the HEI-2020) and engage in less sedentary time at childcare?
Researchers will compare a group of childcare programs who participate in the Boston Healthy Child Care Initiative, and a sample of children who attend those programs, to a similar group of childcare programs who do not participate to see if the quality of meals served, the amounts of physical activity opportunities scheduled, young children's dietary quality, and the minutes/day spent in physical activity increase from before to after the Boston Healthy Child Care Initiative.
Childcare educator participants will:
- Complete the Boston Healthy Child Care Initiative professional development program (for the intervention group only)
- Share copies of menus, schedules, and written policies about nutrition and physical activity in the childcare program
Child participants will:
- Wear ActiGraph wGT3X-BT accelerometers for two days while at childcare to measure physical activity levels. They will do this for two days each at baseline, midline, and follow-up after the initiative concludes.
- Be observed during mealtimes by trained researchers to visually estimate how much they consume at meals and snacks in childcare.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boston Healthy Child Care Initiative - Intervention | Experimental | Other: Boston Healthy Child Care InitiativeChildcare programs assigned to the intervention group will participate in the Boston Healthy Child Care Initiative's professional development program from January- November 2027. |
| Control group (delayed intervention) | No intervention | –Childcare programs assigned to the control group will receive no intervention during 2027 while the intervention group participates in the Boston Healthy Child Care Initiative. After follow-up data collection is completed, however, this group will be offered the opportunity to participate in the Boston Healthy Child Care Initiative in 2028. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 2-5 years old
- Attends early care and education program located in the city of Boston
- At least one parent/guardian reads English or Spanish
Key exclusion criteria (4 listed)
- Ages <2 or >5 years
- Does not attend early care and education
- Attends a program outside of the city of Boston
- Parent/guardian cannot read English or Spanish
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 |
|---|---|---|
| Boston Healthy Child Care InitiativeThe Boston Healthy Child Care Initiative is a professional development and peer-networking program offered by the Boston Public Health Commission for ECE programs in Boston. Building on the evidence-based Go NAP SACC program, it helps ECE educators set goals and create action plans to implement policies and practices that support healthy eating and physical activity for young children. Facilitators, in English and Spanish, share practical, real-world advice and teach skills for how to boost nutrition and physical activity at childcare, and educators connect with one another to share their own tips and help each other problem-solve. BHCCI covers three areas: Nutrition in the First Five Years, Physical Activity Learning Session, and Farm-to-ECE. Programs also receive stipends to support healthy changes. | Other | Boston Healthy Child Care Initiative - Intervention |
Primary outcome
Mean change from baseline to post-intervention in Healthy Eating Index (2020) score for young children's dietary intake while attending childcare.
Time frame: 12 months
The Healthy Eating Index (2020) measures the extent to which dietary intake aligns with standards set by the Dietary Guidelines for Americans (2020). The index ranges from 0-100, with higher scores representing more alignment with the Dietary Guidelines for Americans.
6 secondary outcomes
Mean change from baseline to post-intervention in minutes per day that 2-5 year old children spend in sedentary time while attending childcare
Time frame: 12 months
Mean change from baseline to post-intervention in the percentage of time in childcare that 2-5 year old children spend in sedentary time
Time frame: 12 months
Mean change from baseline to post-intervention in number of best practice nutrition and physical activity policies adopted at the childcare program
Time frame: 12 months
Mean change from baseline to post-intervention in average dynamic acceleration per day among 2-5 children while attending childcare
Time frame: 12 months
Mean change from baseline to post-intervention in accelerometer-measured intensity gradient per day among 2-5 children while attending childcare
Time frame: 12 months
Mean change from baseline to post-intervention in cup-equivalents of fruits and vegetables consumed per day at childcare among 2-5 year old children
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Yes. Data on child participants' changes in dietary intake and physical activity, along with data on child care programs' policy scores, will be made available. Participants' identifying information will be removed so there is no way of tracing the identity of children or childcare programs. Data will be reviewed prior to release to ensure that confidentiality is protected.
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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.
Erica L Kenney, ScD, MPH principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boston Healthy Child Care Initiative in people with Dietary Intakes and Physical Activity, run by Harvard School of Public Health (HSPH) 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 19 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Mozaffarian, MPH (617-433-7448, hprc.research@hsph.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline to post-intervention in Healthy Eating Index (2020) score for young children's dietary intake while attending childcare. (time frame: 12 months). 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 19 Oct 2026.