title: Testing Activity Monitors' Effect on Health: Study Protocol for a Randomized Controlled Trial Among Older Primary Care Patients.
abstract: BACKGROUND
  Cardiovascular disease is the leading cause of mortality in the United States. Maintaining healthy levels of physical activity is critical to cardiovascular health, but many older adults are inactive. There is a growing body of evidence linking low motivation and inactivity. Standard behavioral counseling techniques used within the primary care setting strive to increase motivation, but often do not emphasize the key component of self-control. The addition of electronic activity monitors (EAMs) to counseling protocols may provide more effective behavior change and increase overall motivation for exercise through interactive self-monitoring, feedback, and social support from other users.
  
  
  OBJECTIVE
  The objective of the study is to conduct a three month intervention trial that will test the feasibility of adding an EAM system to brief counseling within a primary care setting. Participants (n=40) will be randomized to receive evidence-based brief counseling plus either an EAM or a pedometer.
  
  
  METHODS
  Throughout the intervention, we will test its feasibility and acceptability, the change in primary outcomes (cardiovascular risk and physical activity), and the change in secondary outcomes (adherence, weight and body composition, health status, motivation, physical function, psychological feelings, and self-regulation). Upon completion of the intervention, we will also conduct focus groups with the participants and with primary care stakeholders.
  
  
  RESULTS
  The study started recruitment in October 2015 and is scheduled to be completed by October 2016.
  
  
  CONCLUSIONS
  This project will lay the groundwork and establish the infrastructure for intervention refinement and ultimately translation within the primary care setting in order to prevent cardiovascular disease on a population level.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02554435; https://clinicaltrials.gov/ct2/show/NCT02554435 (Archived by WebCite at http://www.webcitation/6fUlW5tdT).
authors.affiliation: University of Texas Medical Branch, Division of Rehabilitation Sciences, Galveston, TX, United States. zalewisp@utmb.edu.
authors.forename: Zakkoyya H
authors.identifier: http://orcid.org/0000-0001-8645-6495
authors.initials: ZH
authors.lastname: Lewis
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: Ottenbacher
authors.forename: Steve R
authors.initials: SR
authors.lastname: Fisher
authors.forename: Kristofer
authors.initials: K
authors.lastname: Jennings
authors.forename: Arleen F
authors.initials: AF
authors.lastname: Brown
authors.forename: Maria C
authors.initials: MC
authors.lastname: Swartz
authors.forename: Elizabeth J
authors.identifier: http://orcid.org/0000-0003-1695-2236
authors.initials: EJ
authors.lastname: Lyons
keywords: 5 A counseling; activity monitors; cardiovascular disease; intervention; physical activity; prevention; primary care; technology