Efficacy of an Online Physical Activity Intervention Coordinated With Routine Clinical Care: Protocol for a Pilot Randomized Controlled Trial

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Abstract
Background: Most adults are not achieving recommended levels of physical activity (150 minutes/week, moderate-to-vigorous intensity). Inadequate activity levels are associated with numerous poor health outcomes, and clinical recommendations endorse physical activity in the front-line treatment of obesity, diabetes, dyslipidemia, and hypertension. A framework for physical activity prescription and referral has been developed, but has not been widely implemented. This may be due, in part, to the lack of feasible and effective physical activity intervention programs designed to coordinate with clinical care delivery. Objective: This manuscript describes the protocol for a pilot randomized controlled trial (RCT) that tests the efficacy of a 13-week online intervention for increasing physical activity in adult primary care patients (aged 21-70 years) reporting inadequate activity levels. The feasibility of implementing specific components of a physical activity clinical referral program, including screening for low activity levels and reporting patient program success to referring physicians, will also be examined. Analyses will include participant perspectives on maintaining physical activity. Methods: This pilot study includes a 3-month wait-listed control RCT (1:1 ratio within age strata 21-54 and 55-70 years). After the RCT primary end point at 3 months, wait-listed participants are offered the full intervention and all participants are followed to 6 months after starting the intervention program. Primary RCT outcomes include differences across randomized groups in average step count, moderate-to-vigorous physical activity, and sedentary behavior (minutes/day) derived from accelerometers. Maintenance of physical activity changes will be examined for all participants at 6 months after the intervention start. Results: Recruitment took place between October 2018 and May 2019 (79 participants were randomized). Data collection was completed in February 2020. Primary data analyses are ongoing. Conclusions: The results of this study will inform the development of a clinical referral program for physical activity improvement that combines an online intervention with clinical screening for low activity levels, support for postintervention behavior maintenance, and feedback to the referring physician. Trial Registration: ClinicalTrials.gov NCT03695016; https://clinicaltrials.gov/ct2/show/NCT03695016. International Registered Report Identifier (IRRID): DERR1-10.2196/18891

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