Connected Health Care in Exercise Program for Obesity
Condition: Obesity; Physical Activity; Exercise
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Many kinds of wearable technology have become available, but the superiority of those devices
      in weight loss compared to the standard care without them is uncertain. The possible problems
      are long-term self-motivation, utility and validity of the device, and outcome measures in
      clinical trials. The connected health care with motivational interviewing as an intervention,
      and body composition parameters in addition to body weight as outcome measures are employed
      in the project. The expected outcome is that connected health care, which is more
      individualized approach by heath care professionals, is more effective compared to
      self-monitoring using wearable devices. Two types of wearable device are going to be used to
      monitor 1) body activity and 2) heart rate variables during exercise which reflect fitness
      level in this study in order to investigate appropriate monitoring parameters to predict
      outcome measures.

      The hypothesis is that addition of connected health system will result in improvement of body
      composition and fitness level compared to self-monitoring.
    

Detailed description: 
      Patients with age 18 to 59 years old and body mass index between 30 to 39.9 are to be
      enrolled at Mayo Clinic in Arizona. All enrolled subjects receive wearable monitoring devices
      with remote tracking capability and brochure regarding nutrition and physical exercise with
      basic instruction. Subjects are randomly assigned to connected health care group versus
      self-monitoring group. Connected health care group will have 2 interviews about physical
      exercise and 6 communications with individualized instruction and counseling of their
      exercise including the usage of the monitoring devices. Self-monitoring group will do
      physical exercise following the initial basic instruction and self-monitor them.

      All subjects visit Mayo Clinic to get outcome measures at 0, 12, and 24weeks. Outcome
      measures will be compared before, at 12 weeks, and after the 24 weeks of the fitness program.
    

Intervention name(s): Exercise instruction with motivational interview; Self-monitoring
Intervention type(s): Behavioral; Behavioral
Intervention description(s): An activity tracker and a heart rate monitor to track the participants activity and exercise records will be used. In addition to the basic instruction of exercise and nutrition, an exercise physiologist provides individualized exercise instruction with a motivational interviewing skill, which is a different style from traditional persuasive style of communication between the healthcare professionals and patients.; An activity tracker and a heart rate monitor to track the participants activity and exercise records will be used. Basic instruction about exercise and nutrition is provided at the initial visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Physical Activity; Exercise; Wearable device