Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention

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.

Conditions

• Behavior, Health
• Child Obesity

Interventions

BEHAVIORAL

Greenlight Plus

Families randomized to the Greenlight Plus arm will receive a HIT intervention starting at the newborn clinic visit. During the newborn visit, these families will receive basic instructions on how to access the Greenlight technology platform, which includes the iOTA text-messaging application and a website (usable on desktop or mobile platform). Families will receive text messages and goal-setting over the first 2 years of the child's life.

BEHAVIORAL

Greenlight

All residents and families seen in the participating clinics will receive the basic Greenlight materials.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Duke University

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Stanford University

  collaborator OTHER

• NYU Langone Health

  collaborator OTHER

• University of Miami

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Russell Rothman, MD, MPP · Vanderbilt University Medical Center

• William Heerman, MD, MPH · Vanderbilt University Medical Center

• Charles Wood, MD, MPH · Duke University

• Kori Flower, MD, MS, MPH · University of North Carolina, Chapel Hill

• Lee Sanders, MD, MPH · Stanford University

• H. Shonna Yin, MD, MS · NYU School of Medicine, NYU Langone Health

• Alan Delamater, PhD · University of Miami

• Eliana Perrin, MD, MPH · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Max Age

21 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-11-06

Primary Completion

2024-01-17

Completion

2024-01-17

Countries

• United States

Study Locations