Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial.
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2015-12
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BACKGROUND/AIMS: The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this article is to describe the design and development of the intervention tested in the Cell Phone Intervention for You study and to highlight the importance of adaptive intervention design that made it possible. The Cell Phone Intervention for You study was a National Heart, Lung, and Blood Institute-sponsored, controlled, 24-month randomized clinical trial comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (body mass index≥25 kg/m2) young adults. METHODS: Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, adaptive intervention design, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The adaptive intervention design strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. Adaptive intervention design was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. RESULTS: The cell phone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive-providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools for self-tracking and receiving tailored feedback. The intervention changed over 2 years to promote and sustain engagement. The personal coaching intervention, alternatively, was primarily personal coaching with trained coaches based on a proven intervention, enhanced with a mobile application, but where all interactions with the technology were participant-initiated. CONCLUSION: The complexity and length of the technology-based randomized clinical trial created challenges in engagement and technology adaptation, which were generally discovered using novel remote monitoring technology and addressed using the adaptive intervention design. Investigators should plan to develop tools and procedures that explicitly support continuous remote monitoring of interventions to support adaptive intervention design in long-term, technology-based studies, as well as developing the interventions themselves.
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Lin, Pao-Hwa, Stephen Intille, Gary Bennett, Hayden B Bosworth, Leonor Corsino, Corrine Voils, Steven Grambow, Tony Lazenka, et al. (2015). Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial. Clin Trials, 12(6). pp. 634–645. 10.1177/1740774515597222 Retrieved from https://hdl.handle.net/10161/10740.
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Scholars@Duke
![Lin](https://scholars.duke.edu/profile-images/thumbnail200/0084631.jpg)
Pao-Hwa Lin
My research interest lies generally in the area of dietary patterns and chronic diseases including hypertension using controlled feeding study and lifestyle intervention designs.
Two major controlled feeding clinical trials that I was involved in include the Dietary Approaches to Stop Hypertension (DASH) Study and the Dietary Approaches to Stop Hypertension-Sodium (DASH-Sodium) Study. In addition to being an active member for the diet committee for DASH, I also function as the chair of the diet committee for the DASH-Sodium study. I am familiar with the development and operation of a controlled feeding study, which means the process of study design, development of questionnaire/forms for data collection/monitoring, development of quality assurance procedure, and data analysis.
I've also helped with the design and implementation of the lifestyle behavioral intervention program for the Hypertension Improvement Project (HIP), PREMIER clinical trial, Weight Loss Maintenance trial (WLM), ENCORE study, and the Cell Phone Intervention for You (CITY) trial.
Key words: Diet, controlled feeding study, mineral, blood pressure, nutrition.
![Bennett](https://scholars.duke.edu/profile-images/thumbnail200/0195335.jpg)
Gary G. Bennett
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.
![Bosworth](https://scholars.duke.edu/profile-images/thumbnail200/0212403.jpg)
Hayden Barry Bosworth
Dr. Bosworth is a health services researcher and Deputy Director of the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) at the Durham VA Medical Center. He is also Vice Chair of Education and Professor of Population Health Sciences. He is also a Professor of Medicine, Psychiatry, and Nursing at Duke University Medical Center and Adjunct Professor in Health Policy and Administration at the School of Public Health at the University of North Carolina at Chapel Hill. His research interests comprise three overarching areas of research: 1) clinical research that provides knowledge for improving patients’ treatment adherence and self-management in chronic care; 2) translation research to improve access to quality of care; and 3) eliminate health care disparities.
Dr. Bosworth is the recipient of an American Heart Association established investigator award, the 2013 VA Undersecretary Award for Outstanding Achievement in Health Services Research (The annual award is the highest honor for VA health services researchers), and a VA Senior Career Scientist Award. In terms of self-management, Dr. Bosworth has expertise developing interventions to improve health behaviors related to hypertension, coronary artery disease, and depression, and has been developing and implementing tailored patient interventions to reduce the burden of other chronic diseases. These trials focus on motivating individuals to initiate health behaviors and sustaining them long term and use members of the healthcare team, particularly pharmacists and nurses. He has been the Principal Investigator of over 30 trials resulting in over 400 peer reviewed publications and four books. This work has been or is being implemented in multiple arenas including Medicaid of North Carolina, private payers, The United Kingdom National Health System Direct, Kaiser Health care system, and the Veterans Affairs.
Areas of Expertise: Health Behavior, Health Services Research, Implementation Science, Health Measurement, and Health Policy
![Corsino](https://scholars.duke.edu/profile-images/thumbnail200/0399361.jpg)
Leonor Corsino
Dr. Leonor Corsino is a Board- Certified Adult Endocrinologist, an experienced physician-scientist, and an organizational and health professional education leader. She offers an extensive and diverse leadership background with successfully implementing innovative clinical, research, and workforce development and education programs. Her expertise and strengths lie in her diverse portfolio that expands from basic science to clinical and community-engaged research, innovative curriculum development, successful clinical program implementation, and collaborations.
Dr. Corsino's research focuses on diabetes, obesity, and related complications and health disparities, with a particular interest in Hispanic/Latino populations. She has successfully led and extensively collaborated with investigators locally, nationally, and internationally. Her research and contribution have been recognized locally and nationally with many awards, including the NIH/NIDDK Network of Minority Health Research Investigators medallion.
Dr. Corsino has extensive leadership experience, including her current roles as a member of the Executive Committee Member and Associate Director of the Duke School of Medicine Masters of Biomedical Sciences (MBS), Co-Director for the Duke Clinical and Translational Science Institute - Community Engagement Core / Community-Engaged Research Initiative (CERI) and Associate Dean for Students Affairs/Advisory Dean Duke School of Medicine MD program.
She is the former Co-Director, Education and Training Sub-core of the Duke Center for REsearch to AdvanCe Healthcare Equity, Director of the Duke Population Health Improvement Initiative Program, Associate Chair for the Department of Medicine Minority Recruitment and Retention Committee, and Associate Director for the Duke School of Medicine Office of Faculty Mentoring Training.
Dr. Corsino's leadership led to the successful development and implementation of unique and innovative programs, including the Duke MBS program selective curriculum, the REACH Equity Summer Undergraduate Research Program, the CTSI/CERI Population Health Improvement Award, E-library, consultation services, and the interactive platform for the Duke Population Health Improvement Program.
Her visionary and innovative initiatives have enhanced patient care, population health, and the recruitment, training, development, and support of health professions students, residents, fellows, and junior faculty, having a significant, palpable, impact on the diversity of health profession workforce and health disparities research.
![Grambow](https://scholars.duke.edu/profile-images/thumbnail200/0234282.jpg)
Steven C. Grambow
I am an academic statistician with a focus on educational leadership and administration, teaching, mentoring, and collaborative clinical research. I serve as the director of multiple education programs, both formal degree programs and certificate-based training programs. I also provide administrative oversight of multiple graduate degree programs and educational initiatives focusing on clinical and translational science workforce development at the student, staff, and faculty levels.
I have many years of experience with in-person and online teaching across a variety of teaching venues (formal degree programs, domestic and international certificate-based training programs, faculty development seminars, residency/fellowship training programs) and health sciences audiences (medical students, residents, fellows, faculty, and other health professionals), including more than 21 years as a statistics course director in the Duke Clinical Research Training Program.
As a collaborative scientist I have experience with a broad range of clinical research areas and clinical research designs, including observational studies, epidemiology investigations, and randomized clinical trials, including those utilizing web, mobile, and telemedicine-based health behavior interventions. I have collaborated on projects spanning a broad range of clinical research areas, including amyotrophic lateral sclerosis (ALS), post-traumatic stress disorder (PTSD), Prader-Willi syndrome (PWS), prostate cancer, quality of colorectal cancer care, osteoarthritis, lifestyle modification through weight loss, CVD risk reduction through hypertension control, smoking cessation, and substance abuse recovery.
![Batch](https://scholars.duke.edu/profile-images/thumbnail200/0327206.jpg)
Bryan Courtney Batch
Type 2 Diabetes, Obesity/Overweight, Behavior change, Non-pharmacologic intervention, Health disparities
![Tyson](https://scholars.duke.edu/profile-images/thumbnail200/0510965.jpg)
Crystal Cenell Tyson
As a board-certified nephrologist and a certified clinical hypertension specialist (ASH-SCH), I take care of patients with kidney disorders and/or high blood pressure. Patients with chronic kidney disease and high blood pressure have an increased risk for developing complications of cardiovascular disease, such as heart attacks, congestive heart failure, strokes, kidney failure requiring dialysis or a kidney transplant, and a shortened lifespan. My clinical focus is to slow the progression of chronic kidney disease and reduce complications from cardiovascular disease with lifestyle modification. I particularly enjoy treating patients with severe or difficult to control high blood pressure by focusing on finding an effective medication regimen that provides the least side effects, eliminating ineffective medications, simplifying medication schedules, and promoting healthy lifestyle behavior. I see patients 2 days per week in the Duke Nephrology Clinic and the Duke Nephrology Hypertension Clinic.
My research interests are to reduce racial and health disparities among patients with hypertension and chronic kidney disease using lifestyle modifications. My past and current research investigates the effects of diet (i.e., the DASH diet, sodium reduction), exercise, and weight loss on blood pressure and kidney function, as well as the effect of bilateral renal artery denervation on blood pressure.
![Svetkey](https://scholars.duke.edu/profile-images/thumbnail200/0055370.jpg)
Laura Pat Svetkey
Laura P. Svetkey, MD MHS is Professor of Medicine/Nephrology, Vice Chair for Faculty Development and Diversity in the Department of Medicine. She is also the Director of Duke’s CTSA-sponsored internal career development award program (KL2) and the Associate Director of Duke’s REACH Equity Disparities Research Center, in which she also leads the Investigator Development Core.
Dr. Svetkey has over 30 years of experience in the investigation of hypertension, obesity, and related areas, conducting NIH-sponsored clinical research ranging from behavioral intervention trials to metabolomics and genetics, with a consistent focus on prevention, non-pharmacologic intervention, health disparities and minority health. Her research has affected national guidelines, having served on the 2013 national Hypertension Guideline Panel (JNC) and the Lifestyle Guideline Working Group. She is an American Society of Hypertension certified hypertension specialist, and a member of the Association of American Physicians (AAP). She is the Associate Director, Core Director and Project PI of Duke’s NIH-sponsored REACH Equity Disparities Research Center (PI: Kimberly Johnson).
As Department of Medicine Vice Chair for Faculty Development and Diversity, she implements a wide range of programs to enhance the experience and advancement of faculty and trainees, with particular emphasis on those from racial and ethnic groups under-represented in medicine, and women.
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