NCT06978270Completed
Healthy Start: Family Childcare Providers and Parents
Healthy Start: An Innovative, Multi-level Intervention With Family Childcare Providers and Families to Improve the Dietary Behaviors of Pre-school Children
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 27 Mar 2025
- Start date
- 11 Sept 2025
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Brown University
- Diseases
- Obesity
- NCT number
- NCT06978270
What you commit to
- Study type: Interventional
- Participants enrolled: 11
- From 11 Sept 2025 to the primary completion date, 31 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in the prior Healthy Start Project
- Parents:
Other
- Not meeting above criteria.
- Children:
- \- Not meeting above criteria.
Who the study is looking for
- 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
- 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
- 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).
Criteria the registry did not label
- Providers:
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brown University Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.