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Personalized Interventions for Childhood Obesity (COACH Trial)
N/A
Recruiting
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Child with a body mass index ≥5th percentile for age and gender on standardized CDC growth curves
Consistent mobile phone access
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-month follow-up
Awards & highlights
COACH Trial Summary
This trial failed to produce significant, sustainable results for preventing childhood obesity, especially among minority families. Personalized interventions that take into account the unique circumstances of each family may be more successful.
Who is the study for?
This trial is for families with a parent/guardian at risk for obesity but not severely obese, and a child aged 4-7 years. They must be Hispanic/Latino, speak English or Spanish, have mobile phone access, and commit to a two-year study. Participants should live in specified Nashville zip codes if attending in person or any location for videoconferencing. Families must qualify as underserved by participating in certain assistance programs.Check my eligibility
What is being tested?
The COACH program and School Readiness Intervention are being tested to prevent childhood obesity among low-income minority families. The interventions are personalized to help these families maintain healthy behaviors despite changing barriers.See study design
What are the potential side effects?
Since this trial involves educational and behavioral interventions rather than medications, traditional side effects like those seen with drugs are not expected. However, participants may experience changes in lifestyle habits.
COACH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child's BMI is in the 5th percentile or higher for their age and gender.
Select...
I have regular access to a mobile phone.
Select...
My child is between 4 and 6 years old.
Select...
My guardian's BMI indicates a risk for obesity but not severe obesity.
COACH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Child Body Mass Index
Secondary outcome measures
Child Body Mass Index Percentage of the 95th Percentile
Child Body Mass Index z-Scores
Child Obesity
+2 moreOther outcome measures
Child Diet
Child Media Use
Child Sleep
+2 moreCOACH Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: COACH InterventionExperimental Treatment1 Intervention
COACH is a multi-level intervention, consisting of 1) developmentally appropriate health curriculum for 4-6 year old children; 2) family-based content that both targets parent weight loss and leverages a shared parent-child experience to improve family health behaviors; 3) community-level intervention to improve access and quality of family-based programming at local Parks and Rec centers.
Group II: Educational ControlActive Control1 Intervention
The control arm will consist of a school readiness intervention developed by education and literacy experts on our team and implemented at local libraries. It will include 1) child lessons from Puente de Cuentos, a systematic, language-based curriculum focused on dual language storytelling (narrative language), and 2) parent sessions designed to improve parents' knowledge and skills related to improving children's language production and storytelling skills, to ultimately support school readiness.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
COACH
2008
Completed Phase 4
~720
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
671,857 Total Patients Enrolled
35 Trials studying Obesity
6,581 Patients Enrolled for Obesity
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,430 Total Patients Enrolled
104 Trials studying Obesity
96,772 Patients Enrolled for Obesity
National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
7,492,019 Total Patients Enrolled
103 Trials studying Obesity
25,556 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child's BMI is in the 5th percentile or higher for their age and gender.My child is below the 5th percentile in growth according to CDC charts.I have regular access to a mobile phone.My child is between 4 and 6 years old.My BMI is either below 25 or above 40.My guardian's BMI indicates a risk for obesity but not severe obesity.I am not within the specified age range for children.My parent or guardian has poor eyesight.My parent or legal guardian is under 18 years old.My parent or legal guardian is 18 years old or older.I do not have any health issues that restrict my physical activity.I speak English or Spanish.Spanish is spoken in my home.I do not have a working phone.My child does not speak English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: COACH Intervention
- Group 2: Educational Control
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.
What is the total number of participants in this research project?
"Affirmative. Clinicaltrials.gov confirms that this study is actively seeking participants, with the first posting being on November 18th 2021 and the last update happening on June 20th 2022. Specifically, 300 people are required for enrolment at one medical site."
Answered by AI
Are there vacancies within this trial for participants?
"Affirmative. As per the clinicaltrials.gov listing, this medical experiment which was originally advertised on November 18th 2021 is actively recruiting participants. The study requires 300 enrollees from 1 site."
Answered by AI
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