Healthy Caregivers-Healthy Children

Not Applicable

Active, not recruiting

• Conditions: Child, Only; Obesity
• Interventions: Behavioral: Healthy Caregivers- Healthy children; Behavioral: Jump Start

• Registration Number: NCT05106426
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-10-22
• Study Start: 2021-11-01
• Study First Posted: 2021-11-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-12
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HC2 intervention Group	Healthy Caregivers- Healthy children	Participants in this group will receive the Healthy Caregivers-Healthy Children (HC2) intervention for 24 months
Jump Start Control Group	Jump Start	Participants in this group will receive the Jump Start intervention for 24 months

Primary Outcome Measures

Name	Time	Method
Change in Body Mass Index Percentile	Baseline, Up to 3 years	Body mass index will be collected on children enrolled using participant's height and weight using a percentile score from 0-100
Change in Environment and Policy Assessment and Observation tool) and the Healthy Environment Rating Scale	Baseline, Up to 3 years	Environment and Policy Assessment and Observation Tool has a total score ranging from 0-100 with the higher score indicating greater quality of nutrition

Secondary Outcome Measures

Name	Time	Method
Change in Healthy Caregivers-Healthy Children (HC2) Survey	Baseline, Up to 3 years	Teacher and parents complete this survey on the number of reported nutrition and physical activity practices
Change in Childcare Worker Job Stress Index	Baseline, Up to 3 years	The Childcare Worker Job Stress Index is a total score that ranges from 22 to 110 with higher scores indicating higher levels of stress.
Change in Health Environment Rating Scale	Baseline, Up to 3 years	The Healthy Environment Rating Scale has a total score ranging from 0-100 with the higher score indicating increased healthy practices
Change in Parent Stress Index	Baseline, Up to 3 years	Parents will complete this survey of stress. The Parent Stress Index ranges from 0-100 with higher scores indicating higher levels of stress.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States