IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial
Condition: Obesity; Cardiovascular Disease; Cancer; Diabetes; Sarcopenia
MeSH terms: Sarcopenia; Cardiovascular Diseases
Study type: Interventional

Summary: 
      As individuals age, their physical activity decreases and sedentary time increases. Even
      small changes in these two behaviors can greatly decrease risks for several major health
      problems, including cardiovascular disease, diabetes, and many cancers. Studies that use
      pedometers to encourage walking have successfully increased physical activity, but do not
      address sedentary behaviors such as television watching. The investigators propose to use a
      novel pedometer-like device (Jawbone Up) that encourages both increased physical activity and
      decreased sedentary time. First, the investigators will recruit 10 adults to participate in a
      brief intervention for six weeks. They will wear the wrist-based activity monitor and use a
      mini-tablet device to see feedback on their activity and sedentary time. They will also
      receive brief counseling weekly. The investigators will use this first study to investigate
      the basic feasibility of the intervention materials. Next, the investigators will recruit 20
      adults and randomize them to receive the intervention for 12 weeks or to a waiting list.
      Here, the investigators will test the intervention with refinements made based on participant
      responses from the first small study. Our primary outcomes will be measures of feasibility
      and acceptability across all parts of the study. The investigators hypothesize that the
      intervention will be feasible and acceptable to the participants. The investigators will also
      measure physical activity, sedentary behavior, fitness, body fat, and psychological feelings
      of motivation.
    

Detailed description: 
      Inadequate physical activity and extended bouts of sedentary time are prevalent in adults,
      increasing from middle age into older adulthood. Even small changes in behavior, such as
      standing or walking in place periodically to break up sedentary bouts, can have large effects
      on cardiometabolic risk factors. Pedometer-based walking interventions have demonstrated
      effectiveness in increasing physical activity in this population, but these interventions
      have not targeted sedentary behavior. Recent technological advances have produced activity
      monitors that are capable of intervening on both behaviors. These wrist-worn monitors provide
      feedback and motivation for walking as well as cues to action in the form of idle alerts.
      These idle alerts vibrate when the wearer has remained sedentary for an extended period of
      time. Several preliminary studies have shown that older adults are willing to break up their
      sedentary time if prompted, but interventions thus far have relied upon television
      commercials as a cue to action. Use of these monitors would allow idle alerts to occur
      throughout the day, not only during television watching periods. The purpose of the IMPACT
      study (Inactivity Monitoring and Physical Activity Controlled Trial) is to investigate the
      feasibility of using activity monitors to simultaneously target both physical activity and
      sedentary behavior. First, we will conduct a pre-pilot test (N = 10) over six weeks. This
      brief study will provide basic feasibility and acceptability information on the monitor,
      content for weekly sessions, and assessments. Results will be used to refine the intervention
      for use in a larger pilot two-arm randomized controlled trial (N = 20, 12 weeks). This trial,
      comparing the intervention to a wait-list control group, will test feasibility,
      acceptability, and health, behavioral, and psychological outcomes. The primary outcome will
      be physical activity, operationalized as objectively-measured minutes of moderate-vigorous
      intensity physical activity over seven days (SenseWear armband). We will also measure
      cardiorespiratory fitness, physical function, body composition, and psychosocial variables
      such as autonomous motivation. The results of this innovative project will provide a
      foundation for future intervention in sedentary behavior and potentially create a large
      public health impact in a population at unique risk.
    

Intervention name(s): Monitor intervention
Intervention type(s): Behavioral
Intervention description(s): Investigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide "idle alerts" that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Physical activity; Activity monitor; Technology; Obesity; Aging muscle