A Methodologic Systematic Review of Mobile Health Behavior Change Randomized Trials.

Context: Mobile health helps providers offer accessible, affordable, tailored behavior change interventions. However, research assessing mobile health interventions may feature methodologic shortcomings and poor reporting. This review aims to summarize the characteristics, methods, and intervention reporting of RCTs evaluating mobile health behavior change interventions.

Evidence Acquisition: This was a methodologic systematic review of RCTs assessing mobile health behavior change interventions published in PubMed from January 1, 2014 to January 1, 2018, in journals with the upper half of Impact Factors (Clarivate Analytics). Three reviewers independently extracted sample characteristics. Primary outcomes were classified as patient-important or not using definitions from the literature. Any non-patient-important outcomes were then reclassified by a panel of 3 patients. Intervention reporting was assessed by the mobile health Evidence Reporting and Assessment checklist. Data were analyzed in December 2018.

Evidence Synthesis: Most of the 231 included RCTs assessed text messaging (51%) or smartphone app (28%) interventions aiming to change nutrition and physical activity (36%) or treatment adherence (25%). Only 8% of RCTs had a patient-important primary outcome, follow-up of ≥6 months, and intent-to-treat analysis. Most primary outcomes were behavioral measures (60%). Follow-up was <3 months in 29% of RCTs. Regarding reporting, 12 of the 16 checklist items were reported in less than half of RCTs (e.g., usability/content testing, 32%; data security, 13%).

Conclusions: Reports of RCTs assessing mobile health behavior change interventions lack information that would be useful for providers, including reporting of long-term intervention impact on patient-important primary outcomes and information needed for intervention replicability.