An interventional study of Greenlight Plus and Greenlight in Behavior, Health and Child Obesity, sponsored by Vanderbilt University Medical Center. Completed at 6 sites in United States. Open to participants aged Up to 21 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Prevention
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.
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.
228 studies on the registry are indexed under Health Behavior; 95 are open to participants now.
This study's enrollment of 900 is above the median of 114 across 196 interventional studies indexed under Health Behavior.
Browse Health Behavior studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
For this study, eligible caregiver/infant dyads will be those with:
Exclusion Criteria:
Infant exclusion criteria:
Caregiver exclusion criteria include:
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
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
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.
All residents and families seen in the participating clinics will receive the basic Greenlight materials.
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.
Time frame: Baseline to 24 months
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
Outcome defined by CDC or WHO standards
Time frame: at 24 months
Participants were recruited from medical clinics at six medical centers: Duke University, University of Miami, New York University Grossman School of Medicine/Bellevue Hospital Center, University of North Carolina at Chapel Hill, Stanford University, and Vanderbilt University Medical Center. Study enrollment occurred between November 2019 and August 2021.
| Milestone | Greenlight Plus | Greenlight |
|---|---|---|
| Started | 449 | 451 |
| Completed | 385 | 392 |
| Not completed | 64 | 59 |
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.
| kg/m | Greenlight Plus | Greenlight |
|---|---|---|
| 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 |
| 24 Months | 14.8 ± 1.6 | 15.2 ± 2.0 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Outcome defined by CDC or WHO standards
Results for this outcome have not been posted.
Collected over Adverse event data were collected across the study's 2-year duration for each participant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Greenlight Plus | 0/898 (0%) | 0/898 (0%) | 1/898 (0.1%) |
| Greenlight | 2/902 (0.2%) | 0/902 (0%) | 0/902 (0%) |
The number of individual participants in the Greenlight Plus group was n=898 (449 children and 449 parents), and the number of individual participants in the Greenlight group was n=902 (451 children and 451 parents).
| Age, Customized(weeks) | Greenlight Plus | Greenlight | Total |
|---|---|---|---|
| Child gestational age | 39.3 (38.6 to 40.0) | 39.1 (38.4 to 40.0) | 39.1 (38.4 to 40.0) |
| Age, Customized(years) | Greenlight Plus | Greenlight | Total |
|---|---|---|---|
| Parent age | 30.2 (25.6 to 34.2) | 30.1 (25.6 to 34.4) | 30.1 (25.6 to 34.3) |
| Sex/Gender, Customized(Participants) | Greenlight Plus | Greenlight | Total |
|---|---|---|---|
| Sex of child-Female | 243 | 233 | 476 |
| Sex of child-Male | 206 | 218 | 424 |
| Sex of parent-Female | 433 | 441 | 874 |
| Sex of parent-Male | 15 | 10 | 25 |
| Sex of parent-Other | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Greenlight Plus | Greenlight | Total |
|---|---|---|---|
| Child race/ethnicity — Black, non-Hispanic | 62 | 81 | 143 |
| Child race/ethnicity — Hispanic | 204 | 201 | 405 |
| Child race/ethnicity — White, non-Hispanic | 95 | 90 | 185 |
| Child race/ethnicity — Other or multiple | 86 | 79 | 165 |
| Parent race/ethnicity — Black, non-Hispanic | 68 | 85 | 153 |
| Parent race/ethnicity — Hispanic | 230 | 215 | 445 |
| Parent race/ethnicity — White, non-Hispanic | 104 | 100 | 204 |
| Parent race/ethnicity — Other or multiple | 47 | 51 | 98 |
| Child birth weight(kg) | Greenlight Plus | Greenlight | Total |
|---|---|---|---|
| Median | 3.3 (3.1 to 3.6) | 3.3 (3.0 to 3.6) | 3.3 (3.0 to 3.6) |
| Parent health literacy(Participants) | Greenlight Plus | Greenlight | Total |
|---|---|---|---|
| Adequate | 186 | 185 | 371 |
| Limited | 250 | 250 | 500 |
| Parent preferred language(Participants) | Greenlight Plus | Greenlight | Total |
|---|---|---|---|
| Spanish | 155 | 158 | 313 |
| English | 294 | 293 | 587 |
| Parent education level(Participants) | Greenlight Plus | Greenlight | Total |
|---|---|---|---|
| No school | 1 | 2 | 3 |
| Grade school (K-4) | 5 | 4 | 9 |
| Middle school (5-8) | 26 | 39 | 65 |
| Some high school (9-12) | 58 | 60 | 118 |
| High school graduate or GED | 127 | 101 | 228 |
| Some college or technical/vocational school | 76 | 81 | 157 |
| College degree | 90 | 100 | 190 |
| Post graduate or professional degree | 66 | 64 | 130 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Vanderbilt University Medical Center