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Completed

NCT Number: NCT03446235

Connected Health Care in Exercise Program for Obesity

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.

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Key information

Conditions

Obesity Behavior Body Weight Exercise Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Waist circumference

    Time frame: Baseline and 24 weeks

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

Secondary outcomes

  1. Change in weight

    Time frame: Baseline and 24 weeks

    Weight is measured using a commercially available body weight scale (TANITA body composition monitors). Units kg.

  2. Change in body fat percentage

    Time frame: Baseline and 24 weeks

    Body fat percentage is measured using a commercially available body fat scale (TANITA body composition monitors). Units percentage.

  3. Change in physical activity score

    Time frame: Baseline and 24 weeks

    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.

  4. Change in Physical Activity Vital Sign

    Time frame: Baseline and 24 weeks

    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.

  5. Change in Veterans Specific Activity Questionnaire

    Time frame: Baseline and 24 weeks

    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.

  6. Change in heart rate variables

    Time frame: Baseline and 24 weeks

    Heart rate recovery after 6 minute walk test is evaluated. Units beats/minute.

  7. Change in 6 minute walk test

    Time frame: Baseline and 24 weeks

    Walking distance is evaluated. Units meters.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Arizona State University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 26, 2018
Registry last updated
Jan 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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