Connected Health Care in Exercise Program for Obesity
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 59 |
| Updated: | 1/26/2019 |
| Start Date: | December 4, 2017 |
| End Date: | August 31, 2018 |
Feasibility and Explorative Study to Test the Superiority of Connected Health Care Using Wearable Device to Improve Body Composition and Fitness Level
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.
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.
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.
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.
Inclusion Criteria:
- Body Mass Index of 30 to <40 kg/m^2
Exclusion Criteria:
- End of organ damage from hypertension
- Diabetes
- Liver disease
- Chronic lung disease
- Neuromuscular disease
- Any conditions that limit exercise
- Currently involved in other weight program
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