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Family-Centered Obesity Prevention for Childhood Obesity
N/A
Waitlist Available
Led By Rachel Gross, MD MS
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Latina mother over 18 years with singleton uncomplicated pregnancy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-5 years
Awards & highlights
Study Summary
This trial will test the effectiveness of a primary care, family-centered child obesity prevention program beginning in pregnancy and continuing throughout the first three years of life. The aim is to reduce the prevalence of obesity, improve child diet composition and encourage healthy lifestyle behaviors.
Who is the study for?
This trial is for Latina mothers over 18 with a healthy single pregnancy, planning to get prenatal and pediatric care at specific centers. They must be the child's primary caregiver and speak English or Spanish fluently. Those with serious health issues, substance abuse problems, no phone access, or infants with severe feeding-related medical conditions cannot join.Check my eligibility
What is being tested?
The 'Starting Early' program aims to prevent childhood obesity by educating families from pregnancy through a child's first three years using family groups led by specialists, nutritional videos, and handouts. The study will compare this approach against standard care to see if it reduces obesity rates and improves diet and lifestyle behaviors in children.See study design
What are the potential side effects?
Since this intervention involves educational materials rather than medication, there are no direct side effects like you'd expect from drugs. However, participants may experience changes in family dynamics or stress related to altering their lifestyle habits.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a Latina mother over 18 with a single, uncomplicated pregnancy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Additional Outcome Measures for the Expanded Starting Early Program: Prenatal Intervention
Additional Outcome Measures for the Expanded Starting Early Program: Preschool intervention
Feasibility process measures
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Family groupsExperimental Treatment1 Intervention
Intervention group members will participate in family groups focused on early childhood obesity prevention in addition to standard care from pediatricians at the primary care clinic.
Group II: Standard careActive Control1 Intervention
Mothers enrolled into the control group will continue to receive care from their pediatrician in the primary care clinic.
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Who is running the clinical trial?
United States Department of Agriculture (USDA)FED
97 Previous Clinical Trials
350,420 Total Patients Enrolled
NYU Langone HealthLead Sponsor
1,372 Previous Clinical Trials
840,772 Total Patients Enrolled
Rachel Gross, MD MSPrincipal InvestigatorChildren's Hospital at Montefiore
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a Latina mother over 18 with a single, uncomplicated pregnancy.My mother speaks English or Spanish fluently.My infant has severe health issues that could affect feeding.
Research Study Groups:
This trial has the following groups:- Group 1: Family groups
- Group 2: Standard care
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.
Is there currently a call for participants in this experiment?
"According to clinicaltrials.gov, the recruitment for this medical trial has concluded as of December 7th 2022; however, there are still 1011 other studies actively searching for patients at present. This study was first posted on April 1st 2012."
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