Behavior, HealthNCT04042467

Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention

A study testing Greenlight Plus and Greenlight in people with Behavior, Health and Child Obesity, run by Vanderbilt University Medical Center at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages Up to 21 daysHealthy volunteers can take part
Conditions the study is for: Behavior, Health, Child Obesity
What is being tested?: Greenlight Plus and Greenlight
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 900 participants
Where: 6 sitesUnited States
Study dates: 6 Nov 2019to 17 Jan 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 21 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

Infant 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).
Caregiver exclusion criteria include:
<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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

University of North Carolina
Chapel Hill, North Carolina, 27599
University of Miami
Coral Gables, Florida, 33146
Duke University
Durham, North Carolina, 27708
Vanderbilt University Medical Center
Nashville, Tennessee, 37203-2494
New York University
New York, New York, 10003
Stanford University
Stanford, California, 94305

Other trials in United States

About this study

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

Read the 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
Being tested: Greenlight Plus, Greenlight
Medical subject headings: Health Behavior, Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04042467
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Greenlight

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to 24 months

Secondary outcomes (3)

Child BMI Z-score Trajectory
Measured: Baseline to 24 months
Child Weight-for-length Z-score Trajectory
Measured: Baseline to 24 months
Child Overweight and/or Obesity
Outcome defined by CDC or WHO standards
Measured: at 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Nov 201917 Jan 2024

First posted2 Aug 2019
Study start6 Nov 2019
Primary completion17 Jan 2024
Study completion17 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Behavior, HealthStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 900 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04042467
Sponsor's protocol ID: 190311
Status last verified: Sep 2025
First submitted: 19 Jul 2019
Last updated: 29 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 36323344
Flower KB, Delamater AM, Wallace S, Yin HS, Schilling S, Heerman WJ, Perrin EM, Schildcrout JS, Rothman RL, Wood C, Kay MC, Sanders L. Exploring Relationships Between Clinic Intervention Dosage and Child Weight Trajectories in the Greenlight Plus Trial. J Pediatr. 2026 Sep 3:115313. doi: 10.1016/j.jpeds.2026.115313. Online ahead of print.
PubMed 42692141
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.
PubMed 39489149

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care

All Behavior, Health trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Greenlight Plus Study: A Randomized Study of Approaches to Early Childhood Obesity Prevention
ClinicalTrials.gov ID: NCT04042467
Acronym / sponsor ID: 190311
Conditions: Behavior, Health, Child Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 900 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute, Duke University, University of North Carolina, Chapel Hill, Stanford University, NYU Langone Health, University of Miami, Johns Hopkins University
Study start: 6 Nov 2019 (actual)
Primary completion: 17 Jan 2024 (actual)
Study completion: 17 Jan 2024 (actual)
First posted: 2 Aug 2019 (actual)
Results: Posted 16 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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;

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Greenlight Plus	Experimental	Behavioral: Greenlight Plus, Behavioral: GreenlightFamilies 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.
Greenlight	Active comparator	Behavioral: GreenlightDuring 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.

Who may qualify

Ages: Up to 21 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

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).

Key exclusion criteria (8 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Greenlight PlusFamilies 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.	Behavioural	Greenlight Plus
GreenlightAll residents and families seen in the participating clinics will receive the basic Greenlight materials.	Behavioural	Greenlight, Greenlight Plus

Primary outcome

Child Weight for Length Trajectory
Time frame: Baseline to 24 months
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.

3 secondary outcomes

Child BMI Z-score Trajectory
Time frame: Baseline to 24 months
Child Weight-for-length Z-score Trajectory
Time frame: Baseline to 24 months
Child Overweight and/or Obesity
Time frame: at 24 months

Results and safety

Results posted to the registry on 16 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Greenlight Plus	449	385
Greenlight	451	392

Primary outcome: Child Weight for Length Trajectory

Time frame: Baseline to 24 months. Mean (Standard Deviation). Unit: kg/m

Measure	Greenlight Plus n = 446	Greenlight n = 450
1 Month	8.0 (0.9)	8.0 (0.8)
2 Months	9.3 (1.0)	9.4 (1.0)
4 Months	10.8 (1.2)	11.0 (1.2)
6 Months	11.9 (1.2)	12.0 (1.3)
9 Months	12.7 (1.3)	12.9 (1.3)
12 Months	13.1 (1.3)	13.4 (1.5)
15 Months	13.5 (1.4)	13.8 (1.6)
18 Months	13.9 (1.4)	14.2 (1.6)

Greenlight Plus vs Greenlight: Estimated intervention effect at 24 mo.: -0.33 (95% CI -0.57 to -0.09), p <0.001, Regression, Linear

Population analysed: Follow-up outcome measures were not obtained for 3 Greenlight Plus participants and 1 Greenlight participant. NOTE: While the analysis included data from children (n=896) and their parents (n=896), the unit of analysis was the child. Therefore, the number of participants has been reported consistently across the Participant Flow, Baseline Characteristics, and Outcome Measures sections.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected across the study's 2-year duration for each participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Greenlight Plus	0 of 898 (0%)	1 of 898 (0.1%)	0 of 898
Greenlight	0 of 902 (0%)	0 of 902 (0%)	2 of 902

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 36323344Heerman 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.
Results publication: PubMed 42692141Flower KB, Delamater AM, Wallace S, Yin HS, Schilling S, Heerman WJ, Perrin EM, Schildcrout JS, Rothman RL, Wood C, Kay MC, Sanders L. Exploring Relationships Between Clinic Intervention Dosage and Child Weight Trajectories in the Greenlight Plus Trial. J Pediatr. 2026 Sep 3:115313. doi: 10.1016/j.jpeds.2026.115313. Online ahead of print.
Results publication: PubMed 39489149Heerman 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.

Related trials for Behavior, Health

Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Russell Rothman, MD, MPP principal investigator

Vanderbilt University Medical Center

William Heerman, MD, MPH principal investigator

Vanderbilt University Medical Center

Charles Wood, MD, MPH principal investigator

Duke University

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Greenlight Plus and Greenlight in people with Behavior, Health and Child Obesity, run by Vanderbilt University Medical Center at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child Weight for Length Trajectory (time frame: Baseline to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04042467, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.