Clinical trial NCT04042467: Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention
Official title: Greenlight Plus Study: A Randomized Study of Approaches to Early Childhood Obesity Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Health
Child Obesity
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Duke University
name: University of North Carolina, Chapel Hill
name: Stanford University
name: NYU Langone Health
name: University of Miami
name: Johns Hopkins University
First posted: 2019-08-02
Enrollment: 900
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

Infant 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).

Caregiver exclusion criteria include:

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

Primary outcomes:
measure: Child weight for length trajectory
timeFrame: Baseline to 24 months
Secondary outcomes:
measure: Child BMI Z-score trajectory
timeFrame: Baseline to 24 months
measure: Child weight-for-length z-score trajectory
timeFrame: Baseline to 24 months
measure: Child overweight and/or obesity
timeFrame: at 24 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: New York
country: United States
facility: New York University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Russell Rothman, MD, MPP
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: William Heerman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Charles Wood, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Kori Flower, MD, MS, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Lee Sanders, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU School of Medicine, NYU Langone Health
name: H. Shonna Yin, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Alan Delamater, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Eliana Perrin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.