Your session is about to expire
← Back to Search
HC2 Program for Childhood Obesity (HC3 Trial)
N/A
Waitlist Available
Led By Ruby Natale
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 3 years
Awards & highlights
HC3 Trial Summary
This trial will help to improve the HC2 program so that it more effectively prevents obesity in children.
Who is the study for?
This trial is for low-income families with children aged 2-5, enrolled in a childcare center and reflecting the ethnic diversity of Miami Dade county. It includes kids at risk or with disabilities but excludes those with feeding tubes or special dietary needs.Check my eligibility
What is being tested?
The study tests the 'Health Caregivers Healthy Children (HC2)' program against 'Jump Start', focusing on preventing obesity by promoting healthy eating habits and physical activity among young children.See study design
What are the potential side effects?
Since this trial involves lifestyle interventions like diet changes and increased physical activity, side effects may include initial fatigue or discomfort as families adjust to new routines.
HC3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Body Mass Index Percentile
Change in Environment and Policy Assessment and Observation tool) and the Healthy Environment Rating Scale
Secondary outcome measures
Change in Childcare Worker Job Stress Index
Change in Health Environment Rating Scale
Change in Healthy Caregivers-Healthy Children (HC2) Survey
+1 moreHC3 Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: HC2 intervention GroupExperimental Treatment1 Intervention
Participants in this group will receive the Healthy Caregivers-Healthy Children (HC2) intervention for 24 months
Group II: Parents/Caregivers of Participants receiving HC2 interventionActive Control1 Intervention
Parents/caregivers of participants receiving the HC2 program will not be receiving any intervention.
Group III: Jump Start Control GroupActive Control1 Intervention
Participants in this group will receive the Jump Start intervention for 24 months
Group IV: No Intervention: Parents/Caregivers of participants receiving Jump Start InterventionActive Control1 Intervention
Parents/caregivers of participants receiving the Jump Start program will not be receiving any intervention.
Find a Location
Who is running the clinical trial?
HRSA/Maternal and Child Health BureauFED
31 Previous Clinical Trials
8,632 Total Patients Enrolled
3 Trials studying Obesity
510 Patients Enrolled for Obesity
University of MiamiLead Sponsor
899 Previous Clinical Trials
408,732 Total Patients Enrolled
21 Trials studying Obesity
7,908 Patients Enrolled for Obesity
Ruby NatalePrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
1,200 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My center serves over 30 children aged 2-5 with or at risk for disabilities.My child is between 2 and 5 years old.
Research Study Groups:
This trial has the following groups:- Group 1: HC2 intervention Group
- Group 2: Parents/Caregivers of Participants receiving HC2 intervention
- Group 3: Jump Start Control Group
- Group 4: No Intervention: Parents/Caregivers of participants receiving Jump Start Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there open opportunities for patients to join this experiment?
"Clinicaltrials.gov shows that this medical study, initially listed on November 1st 2021, is currently not recruiting patients. Despite this trial's inactivity, there are 1002 other investigations actively seeking participants at the moment."
Answered by AI
What is this trial aiming to investigate or demonstrate?
"The primary endpoint of this investigation, which will be noted over a Baseline-3 year period, is the amelioration in Environment and Policy Assessment and Observation tool (EPAS) scores as well as Healthy Environment Rating Scale (HERS) metrics. Secondary endpoints encompass variation in Childcare Worker Job Stress Index (CWJSI; 0-110 with higher indicating greater stress), Parent Stress Index (PSI; 0-100 with increased values correlating to elevated tension levels), along with fluctuation in HERS ratings (0-100, where augmentation conveys healthier practises)."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger