NCT04042467Completed
Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention
Greenlight Plus Study: A Randomized Study of Approaches to Early Childhood Obesity Prevention
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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 use, and sleep as compared to Greenlight Plus (intervention) which includes the above materials plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change during well-child checks throughout the first 2 years of life.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 900 (actual)
- First submitted
- 19 Jul 2019
- Start date
- 6 Nov 2019
- Primary completion date
- 17 Jan 2024
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Obesity
- NCT number
- NCT04042467
What you commit to
- Study type: Interventional
- Participants enrolled: 900
- From 6 Nov 2019 to the primary completion date, 17 Jan 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- born prior to 34 weeks gestation or birth weight \<1500 grams; weight \<3rd %tile at enrollment (World Health Organization growth curves); or
Other illness
- 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:
- serious mental or neurologic illness that impairs ability to consent/participate;
- biological mother is HIV-positive
Age
- \<18 years old;
Other
- Infant exclusion criteria:
- poor visual acuity (corrected vision worse than 20/50 with Rosenbaum Screener).
Who the study is looking for
- 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
Age in the registry: - to 21 days · Sex: All · Accepts healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Coral Gables | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| New York University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Stanford University Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.