ObesityBRIDGENCT03678974
Bridging Resources Improve the Development of Guideline-based Exercise
A study testing Exercise Prescription in people with Obesity and Physical Activity, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this pilot study is to more effectively deliver the current standard of care for obesity and physical activity based on current guidelines. The investigators plan to gather preliminary data on physician-directed Intensive Behavioral Therapy for Obesity (IBT-O) utilizing CardioCoachCO2 by KORR technology… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Physical Activity
- What is being tested?
- Exercise Prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2018to 10 Feb 2020
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age 18 years or older
- Obese (BMI ≥30 kg/m2), after taking into account age, gender, ethnicity, fluid status, and muscularity
- Stage of Change Readiness.(Preparation, Action, or Maintenance)
- Pre-participation Screening based on the ASCM 2015 guidelines
- Own a functioning Smart phone compatible with CardioCoach VO2 Max app
Who cannot join
- Any long-term disease that would interfere with their ability to exercise safely for eg Stroke with extremity weakness
- Pregnancy
- Musculoskeletal disorder that prohibits exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
ClevelandCF South Pointe Hospital
Warrensville Heights, Ohio, 44122
About this study
Official title: Targeted Healthcare Efforts to Bridge Resources, Improve the Development of Guideline-based Exercise Prescription and Reduce Obesity by Joining Education, Community, and Technology. (THE BRIDGE PROJECT - Pilot Study)
The purpose of this pilot study is to more effectively deliver the current standard of care for obesity and physical activity based on current guidelines. The investigators plan to gather preliminary data on physician-directed Intensive Behavioral Therapy for Obesity (IBT-O) utilizing CardioCoachCO2 by KORR technology to measure oxygen consumption both at rest and during exercise to assess resting metabolic rate (RMR) and cardiorespiratory fitness (CRF) respectively. RMR and CRF will be incorporated into an exercise prescription through implementation of the CardioCoach VO2 Max App as part of a multi-level physical activity intervention to improve CRF and decrease obesity by acting on multiple levels of the socio-ecological model in a primary care setting.
Read the detailed description
Experimental, One-Group Pretest-Posttest study, in which current physical activity levels and cardiorespiratory fitness (CRF) will be evaluated and assessed at baseline and following 6 months of exercise conditioning. Over the course of 6 months (26 weeks) subjects will have physician based follow up appointments based on IBT-O by CMS criteria with the primary outcome of improving CRF by 1 MET, which has been associated with a 12% decrease in mortality. Secondary outcomes will include meeting changes in BMI consistent with CMS criteria of achieving a weight loss of at least 6.6 lbs (3kg) during the first six months of IBT in order to continue with IBT coverage. Progressing patients safely and efficiently toward achieving current physical activity recommendations within a sample population to guide future research on a larger scale. Through questionnaires the investigators will also gather data on Stages of Change Readiness, osteoarthritis of the knee and other weight-bearing joints, and overall Quality of Life. Subjects will be approved by their primary care physician prior to study participation. Based on American College of Sports Medicine (ACSM's) 2015 preparticipation health screening guidelines, if medical clearance is required then subjects will need to make an appointment with their PCP for exercise clearance prior to subjects' first week of participation and prior to any exercise testing. Information collected will included demographic (age, gender, race, occupation, current employment status) and co-morbid medical conditions such as hypertension, diabetes, coronary artery disease, renal disease, heart failure, etc. or any other significant illness.
On the first day of testing subjects after an overnight fast of at least 12 hours for determination of RMR through indirect calorimetry. After completing the RMR assessment, subjects will complete the following instruments: assessment of current physical activity level, Stage of Readiness to Change, personal health goals, screened by symptom assessment and physical examination for osteoarthritis of the knee and other weight-bearing joints, screening for depression and overall Quality of Life through the application of a questionnaires in a primary care setting.
On the 2nd day subjects will perform a symptom limited cardiopulmonary exercise (CPX) testing on a treadmill using a modified Balke protocol. Subjects will each be provided with their own personal heart rate monitor. The initial graded exercise test will be performed with the heart rate monitor being worn. Subjects will keep their own heart rate monitor during the study, and they will wear them during their workouts so that the app can keep them in their target heart rate zone. They will also wear the monitors during their 6 month graded exercise test. After completion of the CPX, Subjects will be instructed on how to download and utilize the CardioCoach VO2 Max app available on Smartphones which is compatible with Polar H10 Heart rate monitor system.
Subjects will be provided with access to the YMCA within their community to implement their exercise prescription.
This IBT-O model utilizing CardioCoachCO2 technology to improve physical activity, will follow the requirements developed by CMS for coverage of an IBT for Obesity
- One face-to-face visit every week for the first month,
- One face-to-face visit every other week for months 2-6,
- At the six-month visit, a reassessment of Obesity and CRF through CPX. A healthy meal plan has been included as part of standard of care based on CMS IBT guidelines. Subjects will be counseled on the development of a healthy meal plan. This healthy meal plan will incorporate each subject's RMR as the foundation for caloric requirements. In addition to being counseled on the development of a healthy meal plan, subjects will be educated and counseled on Intermittent Fasting (IF).
During the study, the investigators will monitor fitness indicators (physical activity level, weight, BMI, BP, resting HR, VO2Peak, VO2Max, RER, Test time, METpeak, HRmax, HRrecovery, calories burned) and adherence (number of sessions performed at YMCA/month compared goal of 12 exercise sessions/4 weeks), in addition to physical activity performed outside of the YMCA. The Co-PI and subject will work together to determine the subject's desired mode and intensity of physical activity, and then construct an exercise prescription to meet current AACE and ACSM physical activity guideline recommendations.
- Conditions
- Obesity, Physical Activity
- Being tested
- Exercise Prescription
- Keywords
- Cardiorespiratory Fitness, Intensive Behavioral Therapy for Obesity, Exercise Prescription
- 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 PrescriptionBehavioural
The CardioCoach Vo2Max app allows the physician to upload an individual's Vo2 Max and resting metabolic rate results to the app which will allow each subject to view those results in the context of workout zones, goals, and energy balance. The app shows time spent aerobic versus anaerobic, and the actual number of calories burned during a workout and post-workout. It will also show what fuel source (Fats vs Carbs) are being used in real time during your workouts. Subjects can be guided through their workouts utilizing voice coaching to keep you in your customized zones. Additionally, the app accommodates a quick add of calories directly to the app to track calories consumed vs calories burned.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Subjects will receive metabolic testing, exercise prescription, YMCA memberships, and physician based on Intensive Behavioral Therapy for Obesity utilizing CardioCoach app. Receives: Behavioral: Exercise Prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cardiorespiratory Fitness
To evaluate whether exercise feedback will effect subjects' Cardiorespiratory Fitness through implementation of a proposed model of Intensive Behavioral Therapy for Obesity utilizing CardioCoachCO2, CardioCoach VO2 Max app, and H10 HR sensors to provide exercise feedback through comparison of VO2Max and VO2Peak to age and sex match norms. Statistical analysis will be performed on VO2Max,VO2Peak, and maximal MET level obtained during a graded exercise test, from baseline and following 6 months of exercise conditioning to determine if a statistically significant or clinically significant change (improvement of 1 MET) which has demonstrated a 12% decrease in all cause morality.
Measured: 6 Months
Secondary outcomes (1)
Changes in BMI
To evaluate whether exercise feedback will effect subjects' changes in BMI consistent with CMS criteria of achieving a weight loss of at least 6.6 lbs (3kg) during the first six months of Intensive Behavioral Therapy for Obesity by comparing BMI from baseline and following 6 months of exercise conditioning through implementation of a proposed model of Intensive Behavioral Therapy for Obesity utilizing CardioCoachCO2, CardioCoach VO2 Max app, and H10 HR sensors to provide exercise feedback.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start5 Dec 2018
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
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 The Cleveland 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Brentwood Foundation
- Responsible party
- Sponsor
- Investigators
- Debasis Sahoo, MD, Principal investigator, Attending Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678974
- Sponsor's protocol ID
- 18-906
- Acronym
- BRIDGE
- Status last verified
- Feb 2020
- First submitted
- 27 Aug 2018
- Last updated
- 13 Feb 2020
- 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 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Healthcare Efforts to Bridge Resources, Improve the Development of Guideline-based Exercise Prescription and Reduce Obesity by Joining Education, Community, and Technology. (THE BRIDGE PROJECT - Pilot Study)
- ClinicalTrials.gov ID
- NCT03678974
- Acronym / sponsor ID
- BRIDGE / 18-906
- Conditions
- Obesity, Physical Activity
- Keywords
- Cardiorespiratory Fitness, Intensive Behavioral Therapy for Obesity, Exercise Prescription
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Brentwood Foundation
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 20 Sep 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.
The purpose of this pilot study is to more effectively deliver the current standard of care for obesity and physical activity based on current guidelines. The investigators plan to gather preliminary data on physician-directed Intensive Behavioral Therapy for Obesity (IBT-O) utilizing CardioCoachCO2 by KORR technology to measure oxygen consumption both at rest and during exercise to assess resting metabolic rate (RMR) and cardiorespiratory fitness (CRF) respectively. RMR and CRF will be incorporated into an exercise prescription through implementation of the CardioCoach VO2 Max App as part of a multi-level physical activity intervention to improve CRF and decrease obesity by acting on multiple levels of the socio-ecological model in a primary care setting.
Detailed description
Experimental, One-Group Pretest-Posttest study, in which current physical activity levels and cardiorespiratory fitness (CRF) will be evaluated and assessed at baseline and following 6 months of exercise conditioning. Over the course of 6 months (26 weeks) subjects will have physician based follow up appointments based on IBT-O by CMS criteria with the primary outcome of improving CRF by 1 MET, which has been associated with a 12% decrease in mortality. Secondary outcomes will include meeting changes in BMI consistent with CMS criteria of achieving a weight loss of at least 6.6 lbs (3kg) during the first six months of IBT in order to continue with IBT coverage. Progressing patients safely and efficiently toward achieving current physical activity recommendations within a sample population to guide future research on a larger scale. Through questionnaires the investigators will also gather data on Stages of Change Readiness, osteoarthritis of the knee and other weight-bearing joints, and overall Quality of Life. Subjects will be approved by their primary care physician prior to study participation. Based on American College of Sports Medicine (ACSM's) 2015 preparticipation health screening guidelines, if medical clearance is required then subjects will need to make an appointment with their PCP for exercise clearance prior to subjects' first week of participation and prior to any exercise testing. Information collected will included demographic (age, gender, race, occupation, current employment status) and co-morbid medical conditions such as hypertension, diabetes, coronary artery disease, renal disease, heart failure, etc. or any other significant illness.
On the first day of testing subjects after an overnight fast of at least 12 hours for determination of RMR through indirect calorimetry. After completing the RMR assessment, subjects will complete the following instruments: assessment of current physical activity level, Stage of Readiness to Change, personal health goals, screened by symptom assessment and physical examination for osteoarthritis of the knee and other weight-bearing joints, screening for depression and overall Quality of Life through the application of a questionnaires in a primary care setting.
On the 2nd day subjects will perform a symptom limited cardiopulmonary exercise (CPX) testing on a treadmill using a modified Balke protocol. Subjects will each be provided with their own personal heart rate monitor. The initial graded exercise test will be performed with the heart rate monitor being worn. Subjects will keep their own heart rate monitor during the study, and they will wear them during their workouts so that the app can keep them in their target heart rate zone. They will also wear the monitors during their 6 month graded exercise test. After completion of the CPX, Subjects will be instructed on how to download and utilize the CardioCoach VO2 Max app available on Smartphones which is compatible with Polar H10 Heart rate monitor system.
Subjects will be provided with access to the YMCA within their community to implement their exercise prescription.
This IBT-O model utilizing CardioCoachCO2 technology to improve physical activity, will follow the requirements developed by CMS for coverage of an IBT for Obesity
- One face-to-face visit every week for the first month,
- One face-to-face visit every other week for months 2-6,
- At the six-month visit, a reassessment of Obesity and CRF through CPX. A healthy meal plan has been included as part of standard of care based on CMS IBT guidelines. Subjects will be counseled on the development of a healthy meal plan. This healthy meal plan will incorporate each subject's RMR as the foundation for caloric requirements. In addition to being counseled on the development of a healthy meal plan, subjects will be educated and counseled on Intermittent Fasting (IF).
During the study, the investigators will monitor fitness indicators (physical activity level, weight, BMI, BP, resting HR, VO2Peak, VO2Max, RER, Test time, METpeak, HRmax, HRrecovery, calories burned) and adherence (number of sessions performed at YMCA/month compared goal of 12 exercise sessions/4 weeks), in addition to physical activity performed outside of the YMCA. The Co-PI and subject will work together to determine the subject's desired mode and intensity of physical activity, and then construct an exercise prescription to meet current AACE and ACSM physical activity guideline recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise PrescriptionSubjects will receive metabolic testing, exercise prescription, YMCA memberships, and physician based on Intensive Behavioral Therapy for Obesity utilizing CardioCoach app. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults age 18 years or older
- Obese (BMI ≥30 kg/m2), after taking into account age, gender, ethnicity, fluid status, and muscularity
- Stage of Change Readiness.(Preparation, Action, or Maintenance)
- Pre-participation Screening based on the ASCM 2015 guidelines
- Own a functioning Smart phone compatible with CardioCoach VO2 Max app
Key exclusion criteria (3 listed)
- Any long-term disease that would interfere with their ability to exercise safely for eg Stroke with extremity weakness
- Pregnancy
- Musculoskeletal disorder that prohibits exercise
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 PrescriptionThe CardioCoach Vo2Max app allows the physician to upload an individual's Vo2 Max and resting metabolic rate results to the app which will allow each subject to view those results in the context of workout zones, goals, and energy balance. The app shows time spent aerobic versus anaerobic, and the actual number of calories burned during a workout and post-workout. It will also show what fuel source (Fats vs Carbs) are being used in real time during your workouts. Subjects can be guided through their workouts utilizing voice coaching to keep you in your customized zones. Additionally, the app accommodates a quick add of calories directly to the app to track calories consumed vs calories burned. | Behavioural | Exercise |
Primary outcome
Changes in Cardiorespiratory Fitness
Time frame: 6 Months
To evaluate whether exercise feedback will effect subjects' Cardiorespiratory Fitness through implementation of a proposed model of Intensive Behavioral Therapy for Obesity utilizing CardioCoachCO2, CardioCoach VO2 Max app, and H10 HR sensors to provide exercise feedback through comparison of VO2Max and VO2Peak to age and sex match norms. Statistical analysis will be performed on VO2Max,VO2Peak, and maximal MET level obtained during a graded exercise test, from baseline and following 6 months of exercise conditioning to determine if a statistically significant or clinically significant change (improvement of 1 MET) which has demonstrated a 12% decrease in all cause morality.
1 secondary outcome
Changes in BMI
Time frame: 6 Months
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 13 Feb 2020.
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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.
Debasis Sahoo, MD principal investigator
Attending Physician
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 Prescription in people with Obesity and Physical Activity, run by The Cleveland 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 5 inclusion and 3 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 13 Feb 2020. 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?
Changes in Cardiorespiratory Fitness (time frame: 6 Months). 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 13 Feb 2020.