Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial.
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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.
adaptive clinical trial
Randomized Controlled Trials as Topic
Published Version (Please cite this version)10.1177/1740774515597222
Publication InfoLin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; ... Svetkey, Laura P (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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Associate Professor of Medicine
Type 2 Diabetes, Obesity/Overweight, Behavior change, Non-pharmacologic intervention, Health disparities
Professor in the Department of Psychology and Neuroscience
Please note that this is not our primary website.To learn more about Dr. Bennett, please visit: drgarybennett.comTo learn more about Dr. Bennett's work with Duke Digital Health, please visit: dukedigitalhealth.org Gary G. Bennett is the Bishop-MacDermott Family Professor of Psychology & Neuroscience, Global Health, and Medicine at Duke Univ
Professor in Population Health Sciences
Dr. Bosworth is a health services research and Associate Director of the Center for Health Services Research in Primary Care at the Durham VA Medical Center. 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
Associate Professor of Medicine
Dr. Leonor Corsino is a Board- Certified Adult Endocrinologist and an experienced physician-scientist, organizational and health professional education leader. She offers an extensive and diverse leadership background with a successful implementation of innovative programs in clinical, research and workforce development and education. Her expertise and strengths lie in her diverse portfolio that expands from basic science to clinical and community-engaged research, innovative curriculum devel
Assistant Professor of Biostatistics and Bioinformatics
I am a collaborative statistical scientist with experience 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. I have experience designing and analyzing observational studie
Associate Professor in Medicine
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
Professor of Medicine
Laura P. Svetkey, MD MHS is Professor of Medicine/Nephrology, Vice Chair for Faculty Development and Diversity in the Department of Medicine, and School of Medicine Faculty Ombudsperson. She is also the Director of Duke’s CTSA-sponsored internal career development award program (KL2) and the Investigator Development Core of Duke’s REACH Equity Disparities Research Center. Dr. Svetkey has over 30 years of experience in the investigation of hypertension, obe
Assistant Professor of Medicine
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
Adjunct Professor in the Department of Medicine
Randomized trials of behavioral interventions; adherence to treatment regimens; spousal support in chronic disease management, mixed research synthesis; measurement of self-reported medication nonadherence
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