ClinicalTrials.gg
Not yet recruitingNCT07874295IMPLEMENTUpdated Oct 19, 2026

Implementing Modified Practices to Leverage Evidence for Movement, Engagement, and Nutrition Topics in Early Childcare and Education

An interventional study of Boston Healthy Child Care Initiative in Dietary Intakes, Physical Activity and Child Care, sponsored by Harvard School of Public Health (HSPH). Not yet recruiting at 1 site in United States. Open to participants aged 2 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Harvard School of Public Health (HSPH) · Not applicable, Interventional, and Other

Updated Oct 19, 2026Eligibility revisedPrimary outcomes revised+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
456
Allocation
Randomized
Ages
2 Years to 5 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Dietary Intakes
  • Physical Activity
  • Child Care
  • Early Education
  • Children Aged 3-5 Years
  • Toddlers

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Keywords

  • Child care
  • Implementation science
  • Dietary intakes
  • Early care and education
  • Physical Activity
  • Professional development
  • Policy, systems, and environmental change
  • Evidence-based intervention
03

In context

Motor Activity

2,646 studies on the registry are indexed under Motor Activity; 1,205 are open to participants now.

This study's planned enrollment of 456 is above the median of 60 across 2,309 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

Harvard School of Public Health (HSPH) is the lead sponsor of 154 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
456 participants (estimated)

Study arms

  • Experimental
    Boston Healthy Child Care Initiative - Intervention

    Childcare programs assigned to the intervention group will participate in the Boston Healthy Child Care Initiative's professional development program from January- November 2027.

    Other: Boston Healthy Child Care Initiative

  • No intervention
    Control group (delayed 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.

Interventions

  • OtherBoston Healthy Child Care Initiative

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

    Time frame: 12 months

  5. 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.

    Time frame: 12 months

  6. 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

Other outcomes

  1. Mean change from baseline to post-intervention in policies related to vegetable gardening or procuring foods from local producers at the childcare program

    Farm-to-ECE supportive policies

    Time frame: 12 months

07

Study locations

1 site
  • Harvard T.H. Chan School of Public Health
    Boston, Massachusetts 02115, United States
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol

Time frame: Free public access to the data will be available September 2030

Access criteria: The public will have access to the de-identified IPD via the Harvard Dataverse

Data sharing details ↗ · dataverse.harvard.edu

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jun 2028, 20 months later.

Of 1,726 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 47. This study's planned 20 months is below that.

Counting every sponsor, half of 1,738 studies reached it within 23 months; a quarter within 9 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2026
First posted
Oct 14, 2026
StartEst.
Oct 2026
Primary completionEst.
Jun 2028
CompletionEst.
Jun 2028
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Also revised
eligibility, primary outcomes and interventions
Registered
First appeared on the registry
Oct 14, 2026
Show all 2 updates
  1. Oct 19, 2026
    Eligibility Criteria revised
    Primary outcomes Revised (1 change)
    Interventions Arms or interventions changed
  2. Oct 14, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07874295
Responsible party
Erica Kenney (Associate Professor of Public Health Nutrition, Harvard School of Public Health (HSPH)) — Principal investigator
First posted
Oct 14, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Oct 19, 2026

Study contacts

Rebecca Mozaffarian, MPH
Contact
hprc.research@hsph.harvard.edu
617-433-7448
Erica L Kenney, ScD, MPH
principal investigator · Harvard School of Public Health (HSPH)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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