CompletedNot Applicable

Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention

United States900 participantsStarted 2019-11-06

Plain-language 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.

Who can participate

Age range21 Days

SexALL

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Inclusion criteria

✓. 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

✕. 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).
✕. \<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

What they're measuring

Child Weight for Length Trajectory

Timeframe: Baseline to 24 months

Trial details

NCT IDNCT04042467

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-17

Results submitted2025-07-28

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