N/A
N=900
Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention
Behavior, Health · Child Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04042467 ↗Enrolled (actual)
900
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Child Weight for Length Trajectory — 8.0; 8.0; 9.3; 9.4 kg/m — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Greenlight Plus (Behavioral); Greenlight (Behavioral)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Child Weight for Length Trajectory |
8.0; 8.0; 9.3; 9.4; 10.8; 11.0 | <0.001 sig |
| SECONDARY Child BMI Z-score Trajectory |
— | — |
| SECONDARY Child Weight-for-length Z-score Trajectory |
— | — |
| SECONDARY Child Overweight and/or Obesity |
— | — |
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 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.
Eligibility Criteria
Inclusion Criteria
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 Criteria
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
Data sourced from ClinicalTrials.gov (NCT04042467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.