The Balance protocol: a pragmatic weight gain prevention randomized controlled trial for medically vulnerable patients within primary care.
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BackgroundFor patients with obesity who are not ready for or experience barriers to weight loss, clinical practice guidelines recommend provider counseling on preventing further weight gain as a first-line treatment approach. Unfortunately, evidence-based weight gain prevention interventions are not routinely available within primary care. To address this gap, we will implement a pragmatic 12-month randomized controlled trial of a digital weight gain prevention intervention delivered to patients receiving primary care within a network of Federally Qualified Community Health Centers in central North Carolina.
MethodsBalance (Equilibrio in Spanish) is a pragmatic effectiveness trial that will randomize adult patients who have overweight or obesity (BMI of 25-40 kg/m2) to either: 1) a weight gain prevention intervention with tailored behavior change goals and tracking, daily weighing on a network-connected electronic scale, and responsive weight and goal coaching delivered remotely by health center registered dietitians; or 2) a usual care program with automated healthy living text messages and print materials and routine primary care. The primary outcome will be weight gain prevention at 24-months, defined as ≤3% change in baseline weight. To align with its pragmatic design, trial outcome data will be pulled from the electronic health record of the community health center network.
DiscussionFor underserved, often rurally-located patients with obesity, digital approaches to promote a healthy lifestyle can curb further weight gain. Yet enrolling medically vulnerable patients into a weight gain prevention trial, many of whom are from racial/ethnic minorities, can be difficult. Despite these potential challenges, we plan to recruit a large, diverse sample from rural areas, and will implement a remotely-delivered weight gain prevention intervention to medically vulnerable patients. Upcoming trial results will demonstrate the effectiveness of this pragmatic approach to implement and evaluate a digital weight gain prevention intervention within primary care.
Trials registrationNCT03003403 . Registered December 28, 2016.
Published Version (Please cite this version)
Berger, Miriam B, Dori M Steinberg, Sandy Askew, John A Gallis, Cayla C Treadway, Joseph R Egger, Melissa C Kay, Bryan C Batch, et al. (2019). The Balance protocol: a pragmatic weight gain prevention randomized controlled trial for medically vulnerable patients within primary care. BMC public health, 19(1). p. 596. 10.1186/s12889-019-6926-7 Retrieved from https://hdl.handle.net/10161/25595.
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Dr. Steinberg is an Associate Professor in the Duke School of Nursing and at the Duke Global Health Institute. She is also Director of the Duke Global Digital Health Science Center. Her research focuses on digital health interventions for dietary change, and chronic disease management among adults.
Dr. Steinberg is the PI of an NIH-funded R01 grant examining how to best leverage digital health to improve diet quality among individuals with high blood pressure. She was PI on K12 career development grant as Duke BIRCWH Scholar and has been a co-investigator on several successfully funded grants from NIH and Duke. Her work has been featured in the Journal of the American Medical Association, The Journal of the Academy of Nutrition and Dietetics and The American Journal of Public Health, as well as in mass media.
Dr. Steinberg earned her B.S. in Nutrition from the Cornell University, her M.S. in Public Health from Harvard University, and a Ph.D. in Nutrition from the University of North Carolina at Chapel Hill. She is also a Registered Dietitian.
John currently collaborates with researchers and methodologists at the Duke Global Health Institute and the Duke Department of Biostatistics & Bioinformatics. His varied research experience includes design and analysis of weight loss-related randomized controlled trials (RCTs), design and analysis of cluster randomized trials (CRTs), and implementation of the multiphase optimization strategy (MOST). Recently, he has primarily worked with researchers examining the effects of interventions on maternal mental health and child health and development. His research interests include the design of CRTs and analysis methods for clustered data, among many other interests.
Master of Science (Sc.M.) in Biostatistics. Johns Hopkins Bloomberg School of Public Health
Bachelor of Science (B.S.) in Mathematics: Southern Utah University
LinkedIn Profile: https://www.linkedin.com/in/john-gallis-2258b843/
Duke website: https://sites.duke.edu/johngallis/
Melissa Kay is a public health nutritionist conducting research in support of early life obesity prevention. Her educational background includes public health, food policy and applied nutrition, epidemiology, and nutrition interventions. She is currently faculty in the Department of Pediatrics and is using digital technologies to augment clinical care between primary care visits as well as visits with the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). Using interactive text messaging, Dr. Kay supports caregivers in adopting healthy feeding behaviors for themselves and their families.
Type 2 Diabetes, Obesity/Overweight, Behavior change, Non-pharmacologic intervention, Health disparities
Gary G. Bennett, Ph.D., is dean of the Trinity College of Arts & Sciences at Duke University.
As dean, Dr. Bennett is responsible for defining and articulating the strategic mission of Trinity College, ensuring a world-class liberal arts education in a research environment for all students, and attracting, retaining, and nurturing a diverse community of distinguished faculty.
Dr. Bennett is a professor of psychology & neuroscience, global health, medicine, and nursing, and is the founding director of the Duke Digital Health Science Center. He is a global leader in designing, testing, and disseminating digital behavior change interventions. Dr. Bennett developed the interactive obesity treatment approach (iOTA); his recent work demonstrates the effectiveness of digital strategies in treating obesity in the primary care setting.
Nearly 20 years ago, Dr. Bennett created one of the first digital health research programs. His laboratory has since become a global leader in designing, testing, and disseminating digital behavior change interventions, especially for medically vulnerable populations. Dr. Bennett has authored nearly 200 scientific papers, and the National Institutes of Health have continuously funded his research program with more than $20m in grant support. From 2018-2019, Dr. Bennett served as president of the Society of Behavioral Medicine, the nation's largest organization of behavioral change scientists. Dr. Bennett is an elected Academy of Behavioral Medicine Research and Behavioral Medicine Research Council member.
Before assuming his role as dean of Trinity College in February 2023, Dr. Bennett served as vice provost for undergraduate education. He provided strategic vision and leadership for Duke’s undergraduate experience. As vice provost, he oversaw the Office of Undergraduate Education, comprising 15 units that enrich Duke's undergraduate academic experience through academic advising, academic support, nationally competitive scholarships, merit scholar programs, financial aid, study abroad, and several co-curricular programs. Under Bennett’s leadership, Duke introduced several advancements to make the undergraduate experience more enriching and equitable for all students, including the DukeLIFE program to support first-generation and low-income students, and QuadEx, Duke’s inclusive living and learning model that integrates undergraduates’ social, residential and intellectual experiences.
Dr. Bennett is a member of Duke's Bass Society of Fellows and is the founding director of Duke's undergraduate major in global health. He has served on committees to examine Duke's undergraduate curriculum and develop the university's strategic plan and has co-led the Board of Trustees Undergraduate Education Committee since 2018. His students' course ratings have repeatedly placed Dr. Bennett in the top 5% of Duke's undergraduate instructors.
Dr. Bennett has also co-founded three digital health ventures. Crimson Health Solutions developed digital disease management interventions and was acquired by Health Dialog in 2007. In 2014, he co founded Scale Down, a digital obesity treatment startup based on the science of daily self-weighing. Scale Down was acquired by Anthem in 2017. He is a co-founder of Coeus Health, a leading provider of health APIs. Dr. Bennett advises leading digital health and consumer electronic organizations on the science of health behavior change.
Before joining Duke in 2009, Dr. Bennett served on the Harvard School of Public Health and the Dana-Farber Cancer Institute faculties. Dr. Bennett earned a bachelor's degree at Morehouse College, an AM and PhD in clinical health psychology at Duke University, completed a clinical internship in medical psychology at the Duke University Medical Center, and was the Alonzo Yerby postdoctoral fellow in social epidemiology at the Harvard School of Public Health.
Dr. Bennett lives in Raleigh with his wife (also a Duke alum) and his two daughters.
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