Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention

NCT ID: NCT04042467

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-06
• Study Completion Date: 2024-01-17

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.

Detailed Description

The investigators propose a randomized trial to compare the effectiveness of two different approaches to early childhood obesity prevention in children 0-2 years of age. The investigators will randomize 900 parent-infant dyads, recruited from six newborn nurseries/primary care clinics. The participating organizations are part of both CORNET, a national practice-based research network of pediatric residency primary care practices supported by the Academic Pediatric Association (APA), and PCORnet, the national research network supported by PCORI. In the nursery or at the first newborn clinic visit, eligible families will be consented and randomized to one of two arms. In Arm 1 ("Greenlight"), 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. In Arm 2 ("Greenlight Plus"), 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.

Specific Aims & Hypotheses (H) include:

Aim 1: Compare the effectiveness of the 2 arms on weight-for-length and other weight measures through age 2.

H1: Arm 2 will be significantly better than Arm 1 in supporting healthy child weight-for-length trajectory over 2 years;

Aim 2: Compare the effectiveness of the two approaches on parent-reported outcomes, including child feeding and physical activity behaviors, parent feeding beliefs and behaviors, media use, and quality of doctor-patient communication.

H2: Arm 2 will be significantly better at improving parent-reported health behaviors.

Aim 3: Examine differences in main outcomes by social determinants, including race/ethnicity, language, health literacy.

H3: A literacy- and culturally-sensitive approach to obesity prevention will result in equal subgroup improvements.

Aim 4: To compare weight-for-length trajectory over 2 years in both intervention arms with a non-enrolled comparison group, using data from the PCORnet Common Data Model at participating sites.

H4: PCORnet analysis will reveal the benefit of both Greenlight approaches (Arms 1 and 2) compared to before Greenlight intervention implementation and the added benefit of Arm 2 (Greenlight Plus) over other approaches.

Conditions

Behavior, Health; Child Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Greenlight Plus

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.

Group Type: EXPERIMENTAL

Greenlight Plus

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

Greenlight

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.

Group Type: ACTIVE_COMPARATOR

Greenlight

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Greenlight

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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. 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).

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

• Maximum Eligible Age: 21 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Bill Heerman

Assistant Professor, Internal Medicine and Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Russell Rothman, MD, MPP

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

William Heerman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Charles Wood, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University

Kori Flower, MD, MS, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Lee Sanders, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Stanford University

H. Shonna Yin, MD, MS

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine, NYU Langone Health

Alan Delamater, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Eliana Perrin, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Stanford University

Stanford, California, United States

University of Miami

Coral Gables, Florida, United States

New York University

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 36323344 (View on PubMed)

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.

Reference Type: RESULT

PMID: 39489149 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

190311

Identifier Type: -

Identifier Source: org_study_id