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Completed

NCT Number: NCT05106426

Healthy Caregivers-Healthy Children

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.

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Key information

Conditions

Obesity Body Weight Child, Only Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Children with feeding tubes or those that bring their own meals due to dietary restrictions

Treatment and study plan

Healthy Caregivers- Healthy children

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

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.

Primary outcomes

  1. Change in Body Mass Index Percentile

    Time frame: 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

    Time frame: 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 outcomes

  1. Change in Healthy Caregivers-Healthy Children (HC2) Survey

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • HRSA/Maternal and Child Health Bureau

Registry information

Official study title

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

Acronym: HC3

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Nov 3, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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