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Greenlight Interventions for Childhood Obesity
N/A
Waitlist Available
Led By Lee Sanders, MD, MPH
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
Infant born in the newborn nursery with plans to have care in the local clinic OR presenting in that clinic for the first newborn visit (1-21 days of life)
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 months
Awards & highlights
Study Summary
This trial is testing a Greenlight intervention focused on nutrition, physical activity, media use, and sleep habits for infants, compared to a Greenlight Plus intervention which also includes a health information technology component.
Who is the study for?
This trial is for parents with newborns (1-21 days old) planning to stay at the clinic for 2 years, who speak English or Spanish, own a smartphone with data services, and have completed baseline surveys and measurements. Infants born before 34 weeks gestation or underweight are excluded, as well as those with certain medical conditions.Check my eligibility
What is being tested?
The study compares two programs aimed at preventing childhood obesity: 'Greenlight' focuses on nutrition, activity, media use, and sleep; 'Greenlight Plus' adds tech support for family goals during regular check-ups in the first two years of life.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medications, there are no direct side effects like you'd expect from drugs. However, participants may experience changes in lifestyle habits.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My newborn will be or was seen in the local clinic within the first 21 days of life.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Child weight for length trajectory
Secondary outcome measures
Child BMI Z-score trajectory
Child overweight and/or obesity
Child weight-for-length z-score trajectory
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Greenlight PlusExperimental Treatment2 Interventions
Families will receive the Greenlight intervention plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change.
This design allows us to determine if HIT and the asynchronous support it provides between well-child visits can promote additional behavior change and obesity prevention.
Group II: GreenlightActive Control1 Intervention
During each of the recommended well child visits from 0-24 months, pediatric residents, trained in clear health communication skills and shared goal-setting, will use the Greenlight Toolkit of low literacy, age- specific, parent education booklets to promote healthy family behaviors and obesity prevention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Greenlight Plus
2019
N/A
~900
Greenlight
2019
N/A
~900
Find a Location
Who is running the clinical trial?
University of MiamiOTHER
898 Previous Clinical Trials
408,751 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
549 Previous Clinical Trials
29,995,876 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,504 Previous Clinical Trials
4,186,762 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a chronic condition that could affect my weight gain.My biological mother is HIV-positive.My newborn will be or was seen in the local clinic within the first 21 days of life.I am under 18 years old.You must attend the first clinic visit for your newborn baby.You will be able to stay at the clinic for at least 2 years.Before starting the study, we need to collect basic information about you, such as your weight and height, through a survey.My newborn will be or was seen in the local clinic within the first 21 days of life.I was born before 34 weeks or weighed less than 1500 grams at birth.You have a smartphone with internet access.You have a mental or neurological condition that makes it difficult for you to understand the study or give informed consent.My child's guardian can communicate in English or Spanish.My child's guardian can communicate in English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Greenlight Plus
- Group 2: Greenlight
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 any North American sites currently operating this research trial?
"This investigation is happening in 6 distinctive locations, including Durham, Coral Gables and Nashville as well other municipalities. It would be prudent to select the nearest site to decrease travel time if you become a participant of this trial."
Answered by AI
Is this study still open to enrolling participants?
"Unfortunately, the clinical trial referenced on clinicaltrials.gov is no longer recruiting candidates. The original posting date was October 30 2019 and it was last updated on October 17 2022; however, there are 1,074 other studies actively looking for participants across various sites."
Answered by AI
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