Healthy Caregivers-Healthy Children

Obesity Clinical Trial

— HC3  

Official title:

Healthy Caregivers-Healthy Children Phase 3: Children With Special Needs

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05106426
• Other study ID #: 20210902
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: July 2026

Study information

• Verified date: October 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to further develop and examine the Health Caregivers Healthy Children (HC2) program, which encourages obesity prevention through promoting healthy eating and physical activity.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

Center Inclusion Criteria:

1. have >30 children ages 2-to-5 with a with or at-risk for a disability or special healthcare need

2. Serve low income families

3. Reflect the ethnic diversity of the Miami Dade county Public School System (60% Hispanic, 20% non-Hispanic Black, 20% Non Hispanic White).

Child inclusion criteria:

1. Children with an Individual Education Plan or at-risk based on social and economic variables

2. child ages 2-5

3. child enrolled in a childcare center

Exclusion Criteria:

1) Children with feeding tubes or those that bring their own meals due to dietary restrictions

Related Conditions & MeSH terms

• Child, Only
• Obesity

Intervention

Behavioral:
• Healthy Caregivers- Healthy children
The HC2 intervention is an obesity prevention program that provides nutrition and healthy activities programs administered weekly via Zoom or in-person.
• Jump Start
The Jump Start intervention is a behavioral health and safety program that provides behavior management and safety programs administered weekly via Zoom or in-person.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	HRSA/Maternal and Child Health Bureau

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Mass Index Percentile	Body mass index will be collected on children enrolled using participant's height and weight using a percentile score from 0-100	Baseline, Up to 3 years
Primary	Change in Environment and Policy Assessment and Observation tool) and the Healthy Environment Rating Scale	Environment and Policy Assessment and Observation Tool has a total score ranging from 0-100 with the higher score indicating greater quality of nutrition	Baseline, Up to 3 years
Secondary	Change in Healthy Caregivers-Healthy Children (HC2) Survey	Teacher and parents complete this survey on the number of reported nutrition and physical activity practices	Baseline, Up to 3 years
Secondary	Change in Health Environment Rating Scale	The Healthy Environment Rating Scale has a total score ranging from 0-100 with the higher score indicating increased healthy practices	Baseline, Up to 3 years
Secondary	Change in Parent Stress Index	Parents will complete this survey of stress. The Parent Stress Index ranges from 0-100 with higher scores indicating higher levels of stress.	Baseline, Up to 3 years
Secondary	Change in Childcare Worker Job Stress Index	The Childcare Worker Job Stress Index is a total score that ranges from 22 to 110 with higher scores indicating higher levels of stress.	Baseline, Up to 3 years