ObesityNCT03446235
Connected Health Care in Exercise Program for Obesity
A study testing Exercise instruction with motivational interview and Self-monitoring in people with Obesity and Physical Activity, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Obesity, Physical Activity, Exercise
- What is being tested?
- Exercise instruction with motivational interview and Self-monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2017to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body Mass Index of 30 to <40 kg/m^2
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Explorative Study to Test the Superiority of Connected Health Care Using Wearable Device to Improve Body Composition and Fitness Level
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.
Read the 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
- Being tested
- Exercise instruction with motivational interview, Self-monitoring
- Keywords
- Obesity, Physical Activity, Exercise, Wearable device
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise instruction with motivational interviewBehavioural
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-monitoringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Self-monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Waist circumference
Waist circumference is measured by tape at the end expiration while the patient is standing. Units centimeters.
Measured: Baseline and 24 weeks
Secondary outcomes (7)
Change in weight
Weight is measured using a commercially available body weight scale (TANITA body composition monitors). Units kg.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 24 weeks
Change in heart rate variables
Heart rate recovery after 6 minute walk test is evaluated. Units beats/minute.
Measured: Baseline and 24 weeks
Change in 6 minute walk test
Walking distance is evaluated. Units meters.
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start4 Dec 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Principal investigator, Regis Fernandes, Mayo Clinic
- Investigators
- Regis I Fernandes, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446235
- Sponsor's protocol ID
- 17-004529
- Status last verified
- Jan 2019
- First submitted
- 11 Jan 2018
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Explorative Study to Test the Superiority of Connected Health Care Using Wearable Device to Improve Body Composition and Fitness Level
- ClinicalTrials.gov ID
- NCT03446235
- Acronym / sponsor ID
- 17-004529
- Conditions
- Obesity, Physical Activity, Exercise
- Keywords
- Obesity, Physical Activity, Exercise, Wearable device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connected Health | Experimental | Behavioral: Exercise instruction with motivational interviewThis 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. |
| Self-Monitoring | Active comparator | Behavioral: Self-monitoringThis 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body Mass Index of 30 to <40 kg/m^2
Key exclusion criteria (7 listed)
- End of organ damage from hypertension
- Diabetes
- Liver disease
- Chronic lung disease
- Neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise instruction with motivational interviewAn 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. | Behavioural | Connected Health |
| Self-monitoringAn 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. | Behavioural | Self-Monitoring |
Primary outcome
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.
7 secondary outcomes
Change in weight
Time frame: Baseline and 24 weeks
Change in body fat percentage
Time frame: Baseline and 24 weeks
Change in physical activity score
Time frame: Baseline and 24 weeks
Change in Physical Activity Vital Sign
Time frame: Baseline and 24 weeks
Change in Veterans Specific Activity Questionnaire
Time frame: Baseline and 24 weeks
Change in heart rate variables
Time frame: Baseline and 24 weeks
Change in 6 minute walk test
Time frame: Baseline and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regis I Fernandes principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise instruction with motivational interview and Self-monitoring in people with Obesity and Physical Activity, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Waist circumference (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.