NCT05106426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
348

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.1 years

First QC Date

October 22, 2021

Last Update Submit

September 8, 2024

Conditions

ObesityChild, Only

Keywords

obesity preventionchildhoodspecial needs

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Change in Healthy Caregivers-Healthy Children (HC2) Survey

    Baseline, Up to 3 years

  • Change in Health Environment Rating Scale

    Baseline, Up to 3 years

  • Change in Parent Stress Index

    Baseline, Up to 3 years

  • Change in Childcare Worker Job Stress Index

    Baseline, Up to 3 years

Study Arms (4)

HC2 intervention Group

EXPERIMENTAL

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

Behavioral: Healthy Caregivers- Healthy children

Jump Start Control Group

ACTIVE COMPARATOR

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

Behavioral: Jump Start

Parents/Caregivers of Participants receiving HC2 intervention

NO INTERVENTION

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

No Intervention: Parents/Caregivers of participants receiving Jump Start Intervention

NO INTERVENTION

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

Interventions

Healthy Caregivers- Healthy childrenBEHAVIORAL

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

HC2 intervention Group
Jump StartBEHAVIORAL

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.

Jump Start Control Group

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33146, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ruby Natale

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Pediatrics

Study Record Dates

First Submitted

October 22, 2021

First Posted

November 3, 2021

Study Start

November 1, 2021

Primary Completion

December 1, 2023

Study Completion

February 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)