Healthy Start: Family Childcare Providers and Parents (NCT06978270) | Clinical Trial Compass
CompletedNot Applicable
Healthy Start: Family Childcare Providers and Parents
United States11 participantsStarted 2025-09-11
Plain-language summary
The preschool years are a critical time for shaping food preferences and eating behaviors, which affect dietary behaviors in adults and life-long risks for obesity, diabetes, cardiovascular disease, and other chronic conditions. Unfortunately, many US children, especially low-income and ethnic minorities, have dietary patterns associated with obesity and increased morbidity. Thus, to improve child diet quality, it is essential to develop effective targeted interventions in settings where children (especially higher-risk children) spend time. The investigators build upon our efficacious Healthy Start intervention with family childcare home (FCCH) providers (FCCP) to pilot a novel, 8-month multilevel tailored intervention to reach families through FCCH. This would be the first study to incorporate family-based intervention components into FCCH. The 8-month intervention will include an adapted version of the Healthy Start intervention as well as FCCP training to deliver nutrition messages to parents using an existing childcare App, complemented with FCCH environmental cues and tailored print and videos for parents. In sum, feasible and effective interventions to improve young children's diets are urgently needed. The FCCH is a novel and untapped setting to intervene with both FCCP and parents simultaneously to affect children's diets in both childcare and home settings, which has the potential to more fully impact the child's overall diet and weight status.
Who can participate
Age range
18 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.
Providers:
Inclusion Criteria:
* English and/or Spanish-speaking and reading
* State licensed family childcare providers (FCCP)
* FCCP that care for 18-54 month-old children,
* Plan for FCCH to be in operation for the next year
* Willing to be randomized to either study arm,
* Have at least 2 eligible children in their care with at least 1 parent-child dyad consenting to participate
Exclusion Criteria:
* Participation in the prior Healthy Start Project
Parents:
Inclusion Criteria:
* English and/or Spanish-speaking and reading
* Legal guardian of child(ren) who receive care in a participating FCCH
* Child(ren) must be 18-54 months-old
* Care must be for at least 15 hrs./wk
* Plan to continue childcare with their current FCCP for the next 9 months
* Be the caregiver mainly responsible for the child's eating at home
* Willing to be randomized (with the FCCP) to either study arm
Exclusion Criteria:
* Not meeting above criteria.
Children:
Inclusion Criteria:
* Children 18-54 months-old who receive care in a participating FCCH
* Care must be for at least 15 hours per week
* Agree to be measured (All other evaluation is observation that does not require assent).
Exclusion Criteria:
\- Not meeting above criteria.
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.