Status:
COMPLETED
Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Duke University
Conditions:
Behavior, Health
Child Obesity
Eligibility:
All Genders
Up to 21 years
Phase:
NA
Brief Summary
A randomized controlled trial enrolling 900 parent-infant dyads (English and Spanish speaking) comparing Greenlight (control), a behavioral intervention focusing on nutrition, physical activity, media...
Detailed Description
The investigators propose a randomized trial to compare the effectiveness of two different approaches to early childhood obesity prevention in children 0-2 years of age. The investigators will randomi...
Eligibility Criteria
Inclusion
- For this study, eligible caregiver/infant dyads will be those with:
- an English- or Spanish-speaking parent/legal guardian,
- 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),
- attendance at first newborn clinic visit
- no plans to leave the clinic within 2 years
- Completion of baseline data collection (survey data, child weight and length measures prior to randomization).
- Own a smartphone with access to data services
Exclusion
- Infant exclusion criteria:
- born prior to 34 weeks gestation or birth weight \<1500 grams; weight \<3rd %tile at enrollment (World Health Organization growth curves); or
- any chronic medical problem that may affect weight gain (e.g., metabolic disease, uncorrected congenital heart disease, renal disease, high-calorie formula; cleft palate; Down syndrome).
- Caregiver exclusion criteria include:
- \<18 years old;
- serious mental or neurologic illness that impairs ability to consent/participate;
- poor visual acuity (corrected vision worse than 20/50 with Rosenbaum Screener).
- biological mother is HIV-positive
Key Trial Info
Start Date :
November 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2024
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT04042467
Start Date
November 6 2019
End Date
January 17 2024
Last Update
October 16 2025
Active Locations (6)
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1
Stanford University
Stanford, California, United States, 94305
2
University of Miami
Coral Gables, Florida, United States, 33146
3
New York University
New York, New York, United States, 10003
4
University of North Carolina
Chapel Hill, North Carolina, United States, 27599