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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Duke University | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
| Stanford University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
For this study, eligible caregiver/infant dyads will be those with:
Exclusion Criteria:
Infant exclusion criteria:
Caregiver exclusion criteria include:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| University of Miami |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36323344 | Background | 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. | |
| 39489149 |
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Enrollment numbers and number of participants Started/Completed represent the number of dyads (child and parent).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. Greenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials. |
| FG001 | 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. Greenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. Greenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Child gestational age (weeks) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | kg/m | Baseline to 24 months |
|
Adverse event data were collected across the study's 2-year duration for each participant.
AE: Any unfavorable and unintended sign, symptom, laboratory abnormality, or disease associated with study participation.
SAE: Is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in death or persistent or significant disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a participant.
A study-related event follows a temporal sequence from participation and cannot be reasonably explained by other factors.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. Greenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders | Systematic Assessment | Participant selected "yes" to an AE in a self-administered survey. Study team unable to reach participant for further info. Believed to be a misclick but unable to confirm. Case accepted by IRB with no requested changes to protocol. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Filoteia Popescu | Vanderbilt University Medical Center | 615-875-9083 | filoteia.popescu@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 4, 2024 | Feb 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 |
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| OTHER |
| NYU Langone Health | OTHER |
| University of Miami | OTHER |
| Johns Hopkins University | OTHER |
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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.
|
| Greenlight | Behavioral | All residents and families seen in the participating clinics will receive the basic Greenlight materials. |
|
Outcome defined by CDC or WHO standards |
| at 24 months |
| Coral Gables |
| Florida |
| 33146 |
| United States |
| New York University | New York | New York | 10003 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Duke University | Durham | North Carolina | 27708 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203-2494 | United States |
| Result |
| 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. |
| BG001 | 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. Greenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials. |
| BG002 | Total | Total of all reporting groups |
Data is for the gestational age of children only. Data missing for 1 Greenlight Plus participant.
| Median |
| Inter-Quartile Range |
| weeks |
|
| Age, Customized | Data is for the age of parents only. | Median | Inter-Quartile Range | years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Data missing for 2 Greenlight Plus participants. | Count of Participants | Participants |
|
| Child birth weight | Data missing for 1 Greenlight Plus participant. | Median | Inter-Quartile Range | kg |
|
| Parent health literacy | Parent health literacy was assessed by the Newest Vital Sign 6-item literacy screening tool. A score greater than or equal to 4 was categorized as adequate. | Data missing for 13 Greenlight Plus and 16 Greenlight participants. | Count of Participants | Participants |
|
| Parent preferred language | Data is for the preferred language of parents only | Count of Participants | Participants |
|
| Parent education level | Data is for the education level of parents only | Count of Participants | Participants |
|
| Annual household income | Data is for the income of the household | Count of Participants | Participants |
|
| Household food insecurity | Food insecurity was assessed by the 6-item US Department of Agriculture measure. A score greater than or equal to 2 was categorized as food insecure. | Data is for the household. Data missing from 3 Greenlight Plus and 3 Greenlight households. | Count of Participants | Participants |
|
| OG001 | 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. Greenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials. |
|
|
|
| Secondary | Child BMI Z-score Trajectory | Not Posted | Baseline to 24 months | Participants |
| Secondary | Child Weight-for-length Z-score Trajectory | Not Posted | Baseline to 24 months | Participants |
| Secondary | Child Overweight and/or Obesity | Outcome defined by CDC or WHO standards | Not Posted | at 24 months | Participants |
| 0 |
| 898 |
| 0 |
| 898 |
| 1 |
| 898 |
| EG001 | 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. Greenlight: All residents and families seen in the participating clinics will receive the basic Greenlight materials. | 2 | 902 | 0 | 902 | 0 | 902 |
|
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| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| White, non-Hispanic |
|
| Other or multiple |
|
| Hispanic |
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| White, non-Hispanic |
|
| Other or multiple |
|
| Middle school (5-8) |
|
| Some high school (9-12) |
|
| High school graduate or GED |
|
| Some college or technical/vocational school |
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| College degree |
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| Post graduate or professional degree |
|
| $50,000 to $99,999 |
|
| $100,000 or more |
|
| Do not know/not sure |
|
| Prefer not to answer |
|