Back to resultsHealthy Caregivers-Healthy Children (HC3)
Primary Purpose
Obesity, Child, Only
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Caregivers- Healthy children
Jump Start
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring obesity prevention, childhood, special needs
Eligibility Criteria
Center Inclusion Criteria:
- have >30 children ages 2-to-5 with a with or at-risk for a disability or special healthcare need
- Serve low income families
- 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:
- Children with an Individual Education Plan or at-risk based on social and economic variables
- child ages 2-5
- child enrolled in a childcare center
Exclusion Criteria:
1) Children with feeding tubes or those that bring their own meals due to dietary restrictions
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
No Intervention
No Intervention
Arm Label
HC2 intervention Group
Jump Start Control Group
Parents/Caregivers of Participants receiving HC2 intervention
No Intervention: Parents/Caregivers of participants receiving Jump Start Intervention
Arm Description
Participants in this group will receive the Healthy Caregivers-Healthy Children (HC2) intervention for 24 months
Participants in this group will receive the Jump Start intervention for 24 months
Parents/caregivers of participants receiving the HC2 program will not be receiving any intervention.
Parents/caregivers of participants receiving the Jump Start program will not be receiving any intervention.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Change in Healthy Caregivers-Healthy Children (HC2) Survey
Teacher and parents complete this survey on the number of reported nutrition and physical activity practices
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
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.
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.
Full Information
NCT ID
NCT05106426
First Posted
October 22, 2021
Last Updated
October 10, 2023
Sponsor
University of Miami
Collaborators
HRSA/Maternal and Child Health Bureau
1. Study Identification
Unique Protocol Identification Number
NCT05106426
Brief Title
Healthy Caregivers-Healthy Children
Acronym
HC3
Official Title
Healthy Caregivers-Healthy Children Phase 3: Children With Special Needs
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
HRSA/Maternal and Child Health Bureau
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Child, Only
Keywords
obesity prevention, childhood, special needs
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HC2 intervention Group
Arm Type
Experimental
Arm Description
Participants in this group will receive the Healthy Caregivers-Healthy Children (HC2) intervention for 24 months
Arm Title
Jump Start Control Group
Arm Type
Active Comparator
Arm Description
Participants in this group will receive the Jump Start intervention for 24 months
Arm Title
Parents/Caregivers of Participants receiving HC2 intervention
Arm Type
No Intervention
Arm Description
Parents/caregivers of participants receiving the HC2 program will not be receiving any intervention.
Arm Title
No Intervention: Parents/Caregivers of participants receiving Jump Start Intervention
Arm Type
No Intervention
Arm Description
Parents/caregivers of participants receiving the Jump Start program will not be receiving any intervention.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Caregivers- Healthy children
Intervention Description
The HC2 intervention is an obesity prevention program that provides nutrition and healthy activities programs administered weekly via Zoom or in-person.
Intervention Type
Behavioral
Intervention Name(s)
Jump Start
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Body Mass Index Percentile
Description
Body mass index will be collected on children enrolled using participant's height and weight using a percentile score from 0-100
Time Frame
Baseline, Up to 3 years
Title
Change in Environment and Policy Assessment and Observation tool) and the Healthy Environment Rating Scale
Description
Environment and Policy Assessment and Observation Tool has a total score ranging from 0-100 with the higher score indicating greater quality of nutrition
Time Frame
Baseline, Up to 3 years
Secondary Outcome Measure Information:
Title
Change in Healthy Caregivers-Healthy Children (HC2) Survey
Description
Teacher and parents complete this survey on the number of reported nutrition and physical activity practices
Time Frame
Baseline, Up to 3 years
Title
Change in Health Environment Rating Scale
Description
The Healthy Environment Rating Scale has a total score ranging from 0-100 with the higher score indicating increased healthy practices
Time Frame
Baseline, Up to 3 years
Title
Change in Parent Stress Index
Description
Parents will complete this survey of stress. The Parent Stress Index ranges from 0-100 with higher scores indicating higher levels of stress.
Time Frame
Baseline, Up to 3 years
Title
Change in Childcare Worker Job Stress Index
Description
The Childcare Worker Job Stress Index is a total score that ranges from 22 to 110 with higher scores indicating higher levels of stress.
Time Frame
Baseline, Up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Center Inclusion Criteria:
have >30 children ages 2-to-5 with a with or at-risk for a disability or special healthcare need
Serve low income families
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:
Children with an Individual Education Plan or at-risk based on social and economic variables
child ages 2-5
child enrolled in a childcare center
Exclusion Criteria:
1) Children with feeding tubes or those that bring their own meals due to dietary restrictions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruby Natale
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Healthy Caregivers-Healthy Children
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