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Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04042467
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : December 24, 2020
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Duke University
University of North Carolina, Chapel Hill
Stanford University
NYU Langone Health
University of Miami
Information provided by (Responsible Party):
Russell Rothman, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Behavior, Health Child Obesity Behavioral: Greenlight Plus Behavioral: Greenlight Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Prevention
Official Title: Greenlight Plus Study: A Randomized Study of Approaches to Early Childhood Obesity Prevention
Actual Study Start Date : October 30, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : February 2023

Arm Intervention/treatment
Experimental: 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.

Behavioral: 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.

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

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




Primary Outcome Measures :
  1. Child weight for length trajectory [ Time Frame: Baseline to 24 months ]

Secondary Outcome Measures :
  1. Child BMI Z-score trajectory [ Time Frame: Baseline to 24 months ]
  2. Child weight-for-length z-score trajectory [ Time Frame: Baseline to 24 months ]
  3. Child overweight and/or obesity [ Time Frame: at 24 months ]
    Outcome defined by CDC or WHO standards



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042467


Contacts
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Contact: LauraBeth Adams, RD, MBA (615) 875-7298 laura.e.adams@vumc.org
Contact: Taylor Matherly, MPH, M.Ed (615) 875-6940 taylor.e.matherly.1@vumc.org

Locations
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United States, California
Stanford University Not yet recruiting
Stanford, California, United States, 94305
Contact: Michelle Smith    650-736-7265    mcjsmith@stanford.edu   
United States, Florida
University of Miami Not yet recruiting
Coral Gables, Florida, United States, 33146
Contact: Gabriela Guevara       gxg598@miami.edu   
United States, New York
New York University Not yet recruiting
New York, New York, United States, 10003
Contact: Altagracia Soto    978-227-8689    Altagracia.Soto@nyulangone.org   
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Malakha Bility    919-632-5102    malakha_bility@med.unc.edu   
Duke University Not yet recruiting
Durham, North Carolina, United States, 27708
Contact: Carla Mena    919-613-5435    carla.mena@duke.edu   
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37203-2494
Contact: LauraBeth Adams, RD, MBA    615-875-7298    laura.e.adams@vumc.org   
Sponsors and Collaborators
Vanderbilt University Medical Center
Patient-Centered Outcomes Research Institute
Duke University
University of North Carolina, Chapel Hill
Stanford University
NYU Langone Health
University of Miami
Investigators
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Principal Investigator: Russell Rothman, MD, MPP Vanderbilt University Medical Center
Principal Investigator: William Heerman, MD, MPH Vanderbilt University Medical Center
Principal Investigator: Eliana Perrin, 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
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Responsible Party: Russell Rothman, Professor, Internal Medicine and Pediatrics; Professor, Health Policy; Vice President for Population Health Research; Ingram Chair in Integrative and Population Health, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04042467    
Other Study ID Numbers: 190311
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight