Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention

Completed · Not applicable

Conditions studied: Behavior, Health, Child Obesity

In brief

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.

Key facts

Study ID

NCT04042467

Run by

Vanderbilt University Medical Center

People needed

900

Starts

2019-11-06

Expected to finish

2024-01-17

Last updated by the study team

2025-10-16

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University — Stanford, California, United States
• University of Miami — Coral Gables, Florida, United States
• New York University — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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