Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention

Trial ID or NCT#

NCT04042467

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Greenlight Plus Study: A Randomized Study of Approaches to Early Childhood Obesity Prevention

Eligibility Criteria

Ages Eligible for Study: Younger than 21 Days
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. For this study, eligible caregiver/infant dyads will be those with: 1. an English- or Spanish-speaking parent/legal guardian, 2. 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), 3. attendance at first newborn clinic visit 4. no plans to leave the clinic within 2 years 5. Completion of baseline data collection (survey data, child weight and length measures prior to randomization). 6. Own a smartphone with access to data services
Exclusion Criteria:
  1. Infant exclusion criteria: 1. born prior to 34 weeks gestation or birth weight <1500 grams; weight <3rd %tile at enrollment (World Health Organization growth curves); or 2. 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: 1. <18 years old; 2. serious mental or neurologic illness that impairs ability to consent/participate; 3. poor visual acuity (corrected vision worse than 20/50 with Rosenbaum Screener). 4. biological mother is HIV-positive
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Investigator(s)

Lee M. Sanders, MD, MPH

View on ClinicalTrials.gov