Healthy Caregivers-Healthy Children (HC3)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Child, Only
• Intervention / Treatment: Behavioral: Healthy Caregivers- Healthy children; Behavioral: Jump Start

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33146
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HC2 intervention Group; Participants in this group will receive the Healthy Caregivers-Healthy Children (HC2) intervention for 24 months	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.
Active Comparator: Jump Start Control Group; Participants in this group will receive the Jump Start intervention for 24 months	Behavioral: 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.
No Intervention: Parents/Caregivers of Participants receiving HC2 intervention; Parents/caregivers of participants receiving the HC2 program will not be receiving any intervention.
No Intervention: No Intervention: Parents/Caregivers of participants receiving Jump Start Intervention; Parents/caregivers of participants receiving the Jump Start program will not be receiving any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: HRSA/Maternal and Child Health Bureau
• Investigators: Principal Investigator: Ruby Natale, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: childhood; obesity prevention; special needs
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 20210902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No