Connected Health Care in Exercise Program for Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility and Explorative Study to Test the Superiority of Connected Health Care Using Wearable Device to Improve Body Composition and Fitness Level

Conditions
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Obesity, Physical Activity, Exercise

Intervention / Treatment
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* Behavioral: Exercise instruction with motivational interview
* Behavioral: Self-monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Connected Health<br>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<br>* 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.<br>|
| Active Comparator: Self-Monitoring<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Weight is measured using a commercially available body weight scale (TANITA body composition monitors). Units kg. | Baseline and 24 weeks | 
| Change in body fat percentage | Body fat percentage is measured using a commercially available body fat scale (TANITA body composition monitors). Units percentage. | Baseline and 24 weeks | 
| Change in physical activity score | International Physical Activity Questionnaire is filled out by patients. The International Physical Activity Questionnaire Long Form (IPAQ) (www.ipaq.ki.se) is to assess levels and patterns of physical activity. Continuous score expressed as MET (metabolic equivalent)-min/week: MET level*minutes of activity/day*days per week is calculated. Higher number means higher level of physical activity that a subject performed during last 7 days. The estimated range is from 0 to 3000. Units MET-minutes. | Baseline and 24 weeks | 
| Change in Physical Activity Vital Sign | Physical Activity Vital Sign (PAVS) (Greenwood JL, 2010) is a short physical activity assessment using closed ended questions to ask how many days a subject performed physical activity during the past week. Higher number means a subject spent more days on performing physical activity. The range is from 0 to 7. Units days. | Baseline and 24 weeks | 
| Change in Veterans Specific Activity Questionnaire | Veterans Specific Activity Questionnaire (VASQ) (Myers J, 2001) is a brief self administered questionnaire to predict exercise capacity (METs, metabolic equivalents). A subject select the minimum activity level that cause fatigue, short of breath, or discomfort. Higher number means higher fitness level of a subject. the range is from 1 to 13. Units METs. | Baseline and 24 weeks | 
| Change in heart rate variables | Heart rate recovery after 6 minute walk test is evaluated. Units beats/minute. | Baseline and 24 weeks | 
| Change in 6 minute walk test | Walking distance is evaluated. Units meters. | Baseline and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wearable device, Obesity, Physical Activity, Exercise