Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention

NCT04042467 | Completed Results DMC

• 1 other identifier: 190311
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• Child Weight for Length Trajectory

  The primary outcome was child weight for length (kg/m) trajectory over 2 years. Weight and length measurements were obtained during pediatric care visits and abstracted from the medical record.

  Baseline to 24 months

Secondary Outcomes (3)

• Child BMI Z-score Trajectory

  Baseline to 24 months

• Child Weight-for-length Z-score Trajectory

  Baseline to 24 months

• Child Overweight and/or Obesity

  at 24 months

Study Arms (2)

Greenlight Plus

EXPERIMENTAL

Families will receive the Greenlight intervention plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change. This design allows us to determine if HIT and the asynchronous support it provides between well-child visits can promote additional behavior change and obesity prevention.

Behavioral: Greenlight Plus; Behavioral: Greenlight

Greenlight

ACTIVE COMPARATOR

During each of the recommended well child visits from 0-24 months, pediatric residents, trained in clear health communication skills and shared goal-setting, will use the Greenlight Toolkit of low literacy, age- specific, parent education booklets to promote healthy family behaviors and obesity prevention.

Behavioral: Greenlight

Interventions

Greenlight Plus BEHAVIORAL

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.

Greenlight Plus

Greenlight BEHAVIORAL

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

Greenlight; Greenlight Plus

Eligibility Criteria

• Age: Up to 21 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Duke University: collaborator
• University of North Carolina, Chapel Hill: collaborator
• Stanford University: collaborator
• NYU Langone Health: collaborator
• University of Miami: collaborator
• Johns Hopkins University: collaborator

Study Sites (6)

Stanford University

Stanford, California, 94305, United States

Location

University of Miami

Coral Gables, Florida, 33146, United States

Location

New York University

New York, New York, 10003, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203-2494, United States

Location

Related Publications (2)

• Heerman WJ, Perrin EM, Yin HS, Schildcrout JS, Delamater AM, Flower KB, Sanders L, Wood C, Kay MC, Adams LE, Rothman RL. The Greenlight Plus Trial: Comparative effectiveness of a health information technology intervention vs. health communication intervention in primary care offices to prevent childhood obesity. Contemp Clin Trials. 2022 Dec;123:106987. doi: 10.1016/j.cct.2022.106987. Epub 2022 Oct 30.

  PMID: 36323344 BACKGROUND

• Heerman WJ, Rothman RL, Sanders LM, Schildcrout JS, Flower KB, Delamater AM, Kay MC, Wood CT, Gross RS, Bian A, Adams LE, Sommer EC, Yin HS, Perrin EM; Greenlight Investigators; de la Barrera B, Bility M, Cruz Jimenez Smith M, Cruzatte EF, Guevara G, Howard JB, Lampkin J, Orr CJ, Pilotos McBride J, Quintana Forster L, Ramirez KS, Rodriguez J, Schilling S, Shepard WE, Soto A, Velazquez JJ, Wallace S. A Digital Health Behavior Intervention to Prevent Childhood Obesity: The Greenlight Plus Randomized Clinical Trial. JAMA. 2024 Dec 24;332(24):2068-2080. doi: 10.1001/jama.2024.22362.

  PMID: 39489149 RESULT

MeSH Terms

Conditions

Health Behavior; Pediatric Obesity

Condition Hierarchy (Ancestors)

Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Some population groups were underrepresented or not represented (e.g., patients who did not prefer to speak English or Spanish). The study was unable to collect reliable data on web-based dashboard use, limiting the ability to evaluate which digital components of the Greenlight Plus intervention were associated with effectiveness. Anthropometric measures collected during clinical care may be susceptible to measurement error. However, annual training was implemented to minimize errors.

Results Point of Contact

• Title: Filoteia Popescu
• Organization: Vanderbilt University Medical Center

filoteia.popescu@vumc.org

615-875-9083

Study Officials

• Russell Rothman, MD, MPP

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• William Heerman, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Charles Wood, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

• Kori Flower, MD, MS, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Lee Sanders, MD, MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

• H. Shonna Yin, MD, MS

  NYU School of Medicine, NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Alan Delamater, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Eliana Perrin, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All Greenlight Plus personnel that are in a position to change the study protocol or its implementation in study participants should be blinded to information that may allow them to do so, from when the study starts until the study ends, with specific exceptions. This means that all investigators and study staff should be blinded to study data aggregated by study arm that have the potential to impact the study's outcome. The study statistician and programmers s/he designates will be unblinded to post-randomization outcome, mediator, moderator and process data for the purposes of generating DSMB reports. The study statistician will remain objective when carrying out the activities of conducting the trials - preparing randomization schemes, processing of the data, cleaning and editing the data, preparation of analyses/reports of outcome, mediator, moderator and blinded process data, and transmitting those data to the DSMB.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Internal Medicine and Pediatrics

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: August 2, 2019
• Study Start: November 6, 2019
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: October 16, 2025
• Results First Posted: October 16, 2025

Record last verified: 2025-09

Locations

US (6)