Healthy Caregivers-Healthy Children

NCT ID: NCT05106426

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

348 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2024-02-01

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.

Detailed Description

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Conditions

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Obesity Child, Only

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HC2 intervention Group

Participants in this group will receive the Healthy Caregivers-Healthy Children (HC2) intervention for 24 months

Group Type EXPERIMENTAL

Healthy Caregivers- Healthy children

Intervention Type BEHAVIORAL

The HC2 intervention is an obesity prevention program that provides nutrition and healthy activities programs administered weekly via Zoom or in-person.

Jump Start Control Group

Participants in this group will receive the Jump Start intervention for 24 months

Group Type ACTIVE_COMPARATOR

Jump Start

Intervention Type BEHAVIORAL

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.

Parents/Caregivers of Participants receiving HC2 intervention

Parents/caregivers of participants receiving the HC2 program will not be receiving any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).


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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HRSA/Maternal and Child Health Bureau

FED

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Ruby Natale

Associate Professor of Clinical Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruby Natale

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20210902

Identifier Type: -

Identifier Source: org_study_id

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