Healthy Caregivers-Healthy Children

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Child, Only

Intervention / Treatment
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* Behavioral: Healthy Caregivers- Healthy children
* Behavioral: Jump Start


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HC2 intervention Group<br>Participants in this group will receive the Healthy Caregivers-Healthy Children (HC2) intervention for 24 months | Behavioral: Healthy Caregivers- Healthy children<br>* The HC2 intervention is an obesity prevention program that provides nutrition and healthy activities programs administered weekly via Zoom or in-person.<br>|
| Active Comparator: Jump Start Control Group<br>Participants in this group will receive the Jump Start intervention for 24 months | Behavioral: Jump Start<br>* 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.<br>|
| No Intervention: Parents/Caregivers of Participants receiving HC2 intervention<br>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<br>Parents/caregivers of participants receiving the Jump Start program will not be receiving any intervention. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity prevention, childhood, special needs