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Information about ongoing health services research and public health projects

Greenlight Plus study: a randomized study of approaches to early childhood obesity prevention
Investigator (PI): Heerman, William
Past Investigator: Rothman, Russell
Performing Organization (PO): (Current): Vanderbilt University Medical Center, Institute for Medicine and Public Health, Center for Health Services Research / (615) 936-1010
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2019
Final Year: 2024
Record Source/Award ID: PCORI/AD-2018C1-11238
Funding: Total Award Amount: $7,044,647
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Description of the problem our project seeks to solve: More than 25% of preschool children are overweight or obese, and these rates are higher among children in low-income and minority communities.? Even though many families may perceive overweight babies as a sign of good health, increased weight gain during infancy has actually been associated with later risk of becoming obese and having other health problems. One factor that might contribute to pediatric obesity is health literacy. Over 25% of parents have low health literacy and math skills. Low parent health literacy is associated with worse knowledge of breastfeeding, problems mixing formula correctly, difficulty understanding food labels, portion sizes, and growth charts, and higher body mass index (BMI) in children. There are significant gaps in knowledge about how to prevent obesity in early childhood--and in particular the role of primary care providers to help promote healthy lifestyles and prevent obesity with families. Few clinical trials have addressed obesity prevention in the first years of life or have examined the effect of interventions that integrate a literacy-sensitive approach or the use of health technology to improve care. Pediatric primary care clinics, where children see their health care providers frequently for preventive visits in the first two years of life, offer an important opportunity to provide information about childhood obesity prevention that is family-centered and adapted to the literacy needs of families. Additionally, engaging pediatric residents in their primary clinics also represents an important opportunity to improve health disparities, since these clinics care for 1/5 of the socioeconomically disadvantaged families in the country, and represent an opportunity to train pediatric residents in improved approaches to health care delivery that they can adopt as future pediatricians. The use of health technology, such as web/mobile tools and text-messaging can help to support families when they are outside the clinic setting. Over the past 10 years, our team successfully developed and implemented the Greenlight intervention, which applies evidence-based health literacy and health communication approaches to help clinicians work with families to prevent childhood obesity in children 2-24 months of age. The Greenlight intervention was developed with iterative input from families, clinicians, experts in obesity/health communication/cultural tailoring, pediatric residents, and the Academic Pediatric Association (APA) and American Academy of Pediatrics (AAP). The study successfully recruited and followed 865 English- and Spanish-speaking families and over 400 pediatric resident physicians in a randomized trial. The results found that children at Greenlight intervention sites had significant improvement in weight status (BMI z-score) through the first 18 months of life compared to children at comparison sites, but not at 24 months. The proposed Patient-Centered Outcomes Research Institute (PCORI) study will evaluate the scalability/effectiveness of a more robust Greenlight program that begins in the newborn period (rather than at 2 months) and leverages technology to provide more continuous support outside the clinical setting, including asynchronous support as health visits decline in the second year of life. Outcomes we hope to achieve: We will perform a randomized trial, including 900 families, to compare two different approaches to early childhood obesity prevention in children 0-2 years of age. The families will be recruited in the newborn period and cared for at 6 pediatric clinics that participate in 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 newborn period, English- and Spanish-speaking families with new babies will be consented and randomized to one of two arms. In arm 1, during each of the 9 recommended well visits from 0-18 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, known as "Greenlight Plus," families will receive the Greenlight intervention plus a health technology program aimed at supporting family goal setting and behavior change. The technology program includes a customized web/mobile platform for education and behavior change supplemented by a text-messaging system designed and validated for lower socioeconomic status populations. This study design will allow us to determine whether added technology can provide support outside the clinic to promote behavior change and obesity prevention. The study will compare the effectiveness of the 2 arms on children's weight status and family-reported diet and physical activity behaviors and satisfaction with pediatric care through age 2. We anticipate that these outcomes will be better in the Greenlight Plus group compared with the standard Greenlight group. We will also examine the impact of our intervention on key groups by race, ethnicity, language proficiency, and health literacy, and anticipate that our literacy and culturally sensitive approach to obesity prevention will result in equal improvements among subgroups. Brief background on why this project is important to patients: The proposed project and outcomes are of high interest and importance to families. Parents and other caregivers are concerned about child obesity, the potential long-term health consequences of obesity, and how it can be best prevented and treated. Parents want to learn and adopt practices that help their children to develop healthy lifestyles and grow in a healthy way, without becoming overweight. Parents want approaches that are easy to apply, and that provide them increased knowledge, and increased interaction and satisfaction with their health care providers and the health care system. Explanation of how patients and other stakeholder partners will help to make the project successful: The study will engage families/clinicians/health system leaders as co-investigators and advisors, the PCORnet Obesity/Diabetes Collaborative Research Group, and professional organizations (APA, AAP) in ongoing partnerships for study design, implementation, analysis, and dissemination. If proven successful, we plan to develop a scalable approach of the Greenlight Plus program and will work with families, health systems, the APA, the American Academy of Pediatrics, and other stakeholders to implement the program in pediatric clinics across the nation to help improve the health of our young children.
Abstract Archived: This research project is in progress. PCORI will post the research findings on the PCORI website within 90 days after the results are final. What is the research about? Health literacy refers to patients' ability to understand basic health information to make health decisions. Parents with low health literacy may have trouble learning steps to promote healthy weight gain in their babies and prevent childhood obesity. For example, parents may not know the benefits of breastfeeding, how to mix formula correctly, or how to interpret food labels. They may not know that gaining too much weight quickly as a baby can cause health problems later in life. In this study, the research team is comparing two ways to promote healthy weight gain and help prevent obesity. The first way is a program called Greenlight. Greenlight targets parents with low health literacy but is designed to help families of all literacy levels. At regular office check-ups, doctors trained in the program review health education booklets with parents. The booklets focus on breastfeeding, diet, physical activity, and parenting. Doctors help parents set goals around these behaviors. The second way is called Greenlight Plus. In Greenlight Plus, parents receive the Greenlight program plus information to reinforce healthy behaviors between doctor visits. For example, parents get access to the Greenlight website and regular text messages on setting and reaching behavior goals that promote healthy weight gain for babies. Who can this research help? Results may help clinics when considering ways to help parents raise healthy children. What is the research team doing? The research team is recruiting 900 English- and Spanish-speaking parent-infant pairs from six primary care clinics. The team is assigning the pairs by chance to receive either Greenlight or Greenlight Plus for two years. At the start of the study and throughout the child's first two years of life, the team is interviewing families and reviewing medical records to see how each baby is growing. The team wants to know how Greenlight and Greenlight Plus compare in promoting healthy weight gain for different groups based on language, race, ethnicity, and health literacy. Families, clinicians, and experts in health communication helped design the Greenlight program. They are also helping to plan and conduct the study. Research methods. Design: The study design is a randomized controlled trial. Population: The study population is 900 parent-infant dyads. Interventions/comparators are Greenlight and Greenlight Plus. Outcomes: Outcomes are (1) primary: weight-for-length trajectory; and (2) secondary: body mass index z-score trajectory, weight-for-length z-score trajectory, overweight and/or obesity, family-reported beliefs and behaviors, family satisfaction with care, and perception of health communication quality. The timeframe is 2-year follow-up for primary outcome.

MeSH Terms:
  • Adolescent
  • Body Mass Index
  • Body Weight
  • Child
  • Child Health Services /*organization & administration
  • Child Obesity /*prevention & control
  • Child, Preschool
  • Comparative Effectiveness Research
  • Health Literacy
  • Humans
  • Infant
  • Infant, Newborn
  • Internet
  • Language
  • Lifestyle
  • Mathematics
  • Outcome Assessment, Health Care
  • Overweight
  • * Parents
  • Patient Participation
  • Patient Satisfaction
  • Patient-Centered Care
  • Pediatrics /organization & administration
  • Primary Care /organization & administration
  • Program Development
  • Randomized Controlled Trials as Topic
  • Text Messaging
  • United States
Country: United States
State: Tennessee
Zip Code: 37232
UI: 20194076
CTgovId: NCT04042467
Project Status: Ongoing
Record History: ('2020: PI changed; Included alternate abstract in Abstract Archived 1 field. Alternate Title: Comparing two ways to promote healthy weight gain and prevent obesity in early childhood',)