Clinical trial NCT03446235: Connected Health Care in Exercise Program for Obesity
Official title: Feasibility and Explorative Study to Test the Superiority of Connected Health Care Using Wearable Device to Improve Body Composition and Fitness Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Physical Activity
Exercise
Keywords: Obesity
Physical Activity
Exercise
Wearable device
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Arizona State University
First posted: 2018-02-26
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Waist circumference
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Change in weight
timeFrame: Baseline and 24 weeks
measure: Change in body fat percentage
timeFrame: Baseline and 24 weeks
measure: Change in physical activity score
timeFrame: Baseline and 24 weeks
measure: Change in Physical Activity Vital Sign
timeFrame: Baseline and 24 weeks
measure: Change in Veterans Specific Activity Questionnaire
timeFrame: Baseline and 24 weeks
measure: Change in heart rate variables
timeFrame: Baseline and 24 weeks
measure: Change in 6 minute walk test
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Regis I Fernandes
role: PRINCIPAL_INVESTIGATOR
References: