HC3: Healthy Caregivers-Healthy Children

Sponsor
University of Miami (Other)
Overall Status
Recruiting
CT.gov ID
NCT05106426
Collaborator
HRSA/Maternal and Child Health Bureau (U.S. Fed)
1,000
1
4
56
17.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Healthy Caregivers- Healthy children
  • Behavioral: Jump Start
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Healthy Caregivers-Healthy Children Phase 3: Children With Special Needs
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  1. 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

  2. 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

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Miami Miami Florida United States 33146

Sponsors and Collaborators

  • University of Miami
  • HRSA/Maternal and Child Health Bureau

Investigators

  • Principal Investigator: Ruby Natale, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ruby Natale, Associate Professor of Clinical Pediatrics, University of Miami
ClinicalTrials.gov Identifier:
NCT05106426
Other Study ID Numbers:
  • 20210902
First Posted:
Nov 3, 2021
Last Update Posted:
Dec 20, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ruby Natale, Associate Professor of Clinical Pediatrics, University of Miami
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 20, 2021