TAME Health: Testing Activity Monitors' Effect on Health
Condition: Physical Activity
Study type: Interventional

Summary: 
      Cardiovascular disease accounts for 1 in 3 deaths among US adults and is strongly related to
      physical activity. Most older adults do not participate in healthy levels of physical
      activity. Physical activity promotion and counseling from a primary health care provider is
      important for disease prevention. In addition to counseling, an activity monitor can increase
      physical activity through self-regulation. Two types of monitors are available: pedometers
      and electronic activity monitors (EAMs). Research shows that both monitors are motivational
      devices that can increase physical activity. Pedometers count steps of the wearer. EAMs can
      monitor steps, monitor burned calories, quality of sleep, and sedentary time. EAMs may also
      offer more behavioral change techniques and opportunities for self-monitoring. The goal of
      this study is to compare the effectiveness of EAMs compared to a pedometer on increasing
      physical activity and decreasing cardiovascular risk within older adult, primary care
      patients. The study will include sedentary, overweight primary care patients, 55-74 years of
      age with access to a smart phone or tablet. All participants will receive brief physical
      activity counseling. Participants will then be randomized to receive a self-monitoring device
      (Digi-walker CW-700/701 or UP24 by Jawbone) to wear for 3 months. Investigators will evaluate
      the following outcomes: physical activity, cardiovascular risk (Framingham risk calculator,
      fitness), psychological feeling toward exercise, physical function, health status, exercise
      motivation and self-regulation. The investigators hypothesize that EAMs will be more
      effective than pedometers in improving these outcomes. The results of this pilot test will
      aid in the translation of effective physical activity intervention components to primary care
      clinics for cardiovascular disease prevention.
    

Detailed description: 
      Cardiovascular disease (CVD) is prevalent and the leading cause for mortality in the United
      States. The American Heart Association's (AHA) 2020 Impact Goal is to improve the
      cardiovascular health of all Americans by 20 percent while reducing deaths from CVD and
      stroke by 20 percent. Maintaining healthy levels of physical activity (PA) is critical in
      maintaining cardiovascular health, but older adults are inactive. Inactivity may be
      influenced by low levels of motivation. Standard behavioral counseling techniques typically
      implemented within the primary care setting target increased motivation, but lack the key
      component of self-control. The addition of electronic activity monitors (EAMs) that provide
      interactive self-monitoring, feedback, and social support may further increase motivation for
      exercise by providing more effective behavior change techniques than standard protocols.
      Investigators will 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. Investigators propose two Specific Aims:

      AIM 1: Evaluate the feasibility and acceptability of implementing a technology-enhanced brief
      intervention to increase physical activity in a primary care setting. Measures of feasibility
      will include days the EAM was worn, usage of the app, technological problems, attrition, and
      adverse events. Acceptability will be measured by self-report and focus groups.

      AIM 2: Compare the counseling plus EAM intervention to a counseling plus pedometer
      intervention. Primary outcomes will be changes in PA and cardiovascular risk. We will also
      investigate secondary outcomes (differences in adherence, weight and body composition, health
      status, motivation, physical function, psychological feelings, self-regulation).
    

Intervention name(s): EAM; 5 A's counseling; Pedometer
Intervention type(s): Device; Behavioral; Device
Intervention description(s): The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.; Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.; The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
Other intervention name(s): UP24; Jawbone; Electronic Activity Monitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: physical activity; activity monitor; older adults; 5 A's counseling