Connected Health Care in Exercise Program for Obesity

Mayo Clinic

Status: Completed

Conditions: Physical Activity; Obesity; Exercise

Treatments: Behavioral: Exercise instruction with motivational interview; Behavioral: Self-monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT03446235

17-004529

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Connected Health

Experimental group

Description:

This group will get 2 interviews about physical exercise (exercise instruction with motivational interview) and 6 communications with individualized instruction and counseling of their physical exercise (investigators can access activity data and exercise log) including the usage of the monitoring device.

Treatment:

Behavioral: Exercise instruction with motivational interview

Self-Monitoring

Active Comparator group

Description:

This group will do physical exercise following the initial instruction and self-monitor them. Investigators can access activity data and exercise log but will not discuss with the subjects about the data.

Treatment:

Behavioral: Self-monitoring