TerminatedNot Applicable

Family-centered Obesity Prevention: Communities for Healthy Living (CHL)

Stopped: The primary trial was halted due to covid-19 in the last 6 months of the trial; as a result, the intervention was not fully implemented and the final outcomes were not measured. Outcomes will be assessed with the data available (BL, Y1, Y2).

United States4,999 participantsStarted 2017-10-01

Plain-language summary

The Communities for Healthy Living (CHL) program is a family-focused intervention to promote healthy lifestyle behaviors including diet and physical activity among children (age 3-to 5-years) and their families, enrolled in Head Start.

Who can participate

Age range

3 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Primary Outcome Measures Inclusion: * Enrolled in a participating Head Start program * Age 33 months to 5 years (i.e., meets Head Start age eligibility criteria) Exclusion: * Those not meeting inclusion criteria Secondary Outcome Measures Inclusion: * Enrolled in a participating Head Start program * Age 33 months to 5 years Exclusion: * Children not enrolled at a participating Head Start program * Children less than 29 months or older than 59 months by Sept 1

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Child BMI-z score

Timeframe: Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned

Modified change in BMI z-score

Timeframe: Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2)

Trial details

NCT IDNCT03334669

SponsorBoston College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-31

View on ClinicalTrials.gov More Pediatric Obesity trials