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Healthy Caregivers-Healthy Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05106426
Acronym
HC3
Enrollment
348
Registered
2021-11-03
Start date
2021-11-01
Completion date
2024-02-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child, Only, Obesity

Keywords

obesity prevention, childhood, special needs

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.

Interventions

BEHAVIORALHealthy 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.

BEHAVIORALJump 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.

Sponsors

HRSA/Maternal and Child Health Bureau
CollaboratorFED
University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Body Mass Index PercentileBaseline, Up to 3 yearsBody 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 ScaleBaseline, Up to 3 yearsEnvironment and Policy Assessment and Observation Tool has a total score ranging from 0-100 with the higher score indicating greater quality of nutrition

Secondary

MeasureTime frameDescription
Change in Healthy Caregivers-Healthy Children (HC2) SurveyBaseline, Up to 3 yearsTeacher and parents complete this survey on the number of reported nutrition and physical activity practices
Change in Health Environment Rating ScaleBaseline, Up to 3 yearsThe Healthy Environment Rating Scale has a total score ranging from 0-100 with the higher score indicating increased healthy practices
Change in Parent Stress IndexBaseline, Up to 3 yearsParents 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 IndexBaseline, Up to 3 yearsThe Childcare Worker Job Stress Index is a total score that ranges from 22 to 110 with higher scores indicating higher levels of stress.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026