Connected Health Care in Exercise Program for Obesity

NCT03446235 | Completed

• 1 other identifier: 17-004529
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Physical Activity; Exercise

Keywords

Obesity; Physical Activity; Exercise; Wearable device

Outcome Measures

Primary Outcomes (1)

• Change in Waist circumference

  Waist circumference is measured by tape at the end expiration while the patient is standing. Units centimeters.

  Baseline and 24 weeks

Secondary Outcomes (7)

• Change in weight

  Baseline and 24 weeks

• Change in body fat percentage

  Baseline and 24 weeks

• Change in physical activity score

  Baseline and 24 weeks

• Change in Physical Activity Vital Sign

  Baseline and 24 weeks

• Change in Veterans Specific Activity Questionnaire

  Baseline and 24 weeks

Study Arms (2)

Connected Health

EXPERIMENTAL

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.

Behavioral: Exercise instruction with motivational interview

Self-Monitoring

ACTIVE COMPARATOR

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.

Behavioral: Self-monitoring

Interventions

Exercise instruction with motivational interview 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.

Connected Health

Self-monitoring 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.

Self-Monitoring

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index of 30 to \<40 kg/m\^2

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Arizona State University: collaborator

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Interventions

Motivational Interviewing; Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• Regis I Fernandes

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: February 26, 2018
• Study Start: December 4, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: January 24, 2019

Record last verified: 2019-01

Locations

US (1)