Connected Health Care in Exercise Program for Obesity

NCT ID: NCT03446235

Last Updated: 2019-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-04
• Study Completion Date: 2018-08-31

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.

Conditions

Obesity; Physical Activity; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Connected Health

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.

Group Type: EXPERIMENTAL

Exercise instruction with motivational interview

Intervention Type: BEHAVIORAL

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.

Self-Monitoring

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.

Group Type: ACTIVE_COMPARATOR

Self-monitoring

Intervention Type: BEHAVIORAL

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.

Interventions

Exercise instruction with motivational interview

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.

Intervention Type: BEHAVIORAL

Self-monitoring

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arizona State University

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Regis Fernandes

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Regis I Fernandes

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Countries

United States

Other Identifiers

17-004529

Identifier Type: -

Identifier Source: org_study_id