Loading clinical trials...
Loading clinical trials...
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.
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.
Age
18 - 59 years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Start Date
December 4, 2017
Primary Completion Date
August 31, 2018
Completion Date
August 31, 2018
Last Updated
January 24, 2019
19
ACTUAL participants
Exercise instruction with motivational interview
BEHAVIORAL
Self-monitoring
BEHAVIORAL
Lead Sponsor
Mayo Clinic
Collaborators
NCT07472881
NCT01143454
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions