Background and method of the Striving to be Strong study a RCT testing the efficacy of a m-health self-management intervention. Contemp Clin Trials 2018 Aug;71:80-87
Date
06/13/2018Pubmed ID
29894865DOI
10.1016/j.cct.2018.06.006Scopus ID
2-s2.0-85048278984 (requires institutional sign-in at Scopus site) 14 CitationsAbstract
BACKGROUND: Osteoporosis is a prevalent and debilitating condition affecting >50% of post-menopausal women. Yet, a low percentage of women regularly engage in health promoting behaviors associated with osteoporosis prevention. Complex, multidimensional, m-Health interventions hold promise to effect engagement in health behavior change related to calcium and vitamin D intake, balance, core and leg strength, and physical activity.
METHODS: Striving to be Strong study (R01NR013913-01) tests the efficacy of a research and theory based, patient centered, dynamically tailored intervention delivered via smart phone apps. Ecological Momentary Assessments (EMAs) enhance immediate feedback and complement traditional measures. The desired outcomes are the maintenance of osteoporosis self-management behaviors and a decrease in the loss of bone density over time. The Individual and Family Self-management Theory provided the conceptual foundation for the study. The sample consists of 290 healthy women between the ages of 40 and 60 with an anticipated attrition of 33%. This three group repeated measures Randomized Clinical Trial spans a 12-month time period. Data collected occurs via web site, smart-phone app, self-report, observation, and measures. Proximal (engagement in osteoporosis health behaviors) and distal (serum vitamin D, DXA, and body composition) outcomes are collected for testing of the efficacy of the intervention and theory evaluation.
DISCUSSION: Active and rigorous quality management processes continually evaluate enrollment and retention goals, functionality of the automated intervention delivery and data collection systems, EMAs, and dispersion of incentives.
Author List
Ryan P, Papanek P, Csuka ME, Brown ME, Hopkins S, Lynch S, Scheer V, Schlidt A, Yan K, Simpson P, Hoffman R, Striving to be Strong TeamAuthors
Mary Ellen Csuka MD Professor in the Medicine department at Medical College of WisconsinPaula Papanek PhD, MPT, LAT, FACSM Associate Professor & Director of Exercise Science in the Exercise Science & Physical Therapy department at Marquette University
Pippa M. Simpson PhD Adjunct Professor in the Pediatrics department at Medical College of Wisconsin
Ke Yan PhD Associate Professor in the Pediatrics department at Medical College of Wisconsin
MESH terms used to index this publication - Major topics in bold
Data CollectionExercise
Female
Health Behavior
Health Education
Humans
Middle Aged
Mobile Applications
Osteoporosis, Postmenopausal
Osteoporotic Fractures
Patient-Centered Care
Quality Improvement
Self-Management
Smartphone
Telemedicine