Weight LossBCSPNCT04516473
The Impact of Abdominal Body Contouring Surgery on Physical Function After a Massive Weight Loss (BCSP)
An observational study of Weight Loss and Obesity, run by University of British Columbia at 1 site in Canada.
Trial summary
Obesity is a growing chronic medical condition in which as of 2015, a total of 107.7 million children and 603.7 million adults were considered obese and since 1980 the prevalence of obesity has doubled in more than 70 countries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Weight Loss, Obesity
- What is being tested?
- Abdominal Body Contouring
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 18 Aug 2020to 29 Dec 2021
- Phase
- Observational
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Male and female who have undergone a massive weight loss through any weight loss intervention, have excess skin, are healthy enough to perform simple physical function tasks and self-selected to undergo abdominal skin removal surgery. Participants who have similar criteria to the intervention group but will not undergo surgical intervention during the course of the study will serve as a control group.
Who may be able to join
- Weight has not deviated by greater than 5 percent for 3 months
- Have excess grade skin of greater or equal to 2
- Percent total weight loss pre-body contouring of greater or equal to 25 percent
- Fluently read and write English
Who cannot join
- Any musculoskeletal issues that would prevent participants from doing the physical function tests.
- Current medication history indicating atypical antipsychotics including but not limited to clozapine, olanzapine, quetiapine, risperidone, aripiprazole, amisulpride, ziprasidone, asenapine, iloperidone, lurasidone and paliperidone.
- Severe pulmonary conditions such as severe chronic obstructive pulmonary disease (COPD) and or severe asthma.
- Participants who actively aiming to lose weight
- Have diabetes with diabetic neuropathy or experienced hypoglycemic event within 6 months prior to the study
- Severe kidney disease with estimated glomerular filtration rate (eGFR) less than 60 ml/min
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- Pregnant individuals
- Uncontrolled hypertension with resting blood pressure greater than 160/90 mmHg
- Uncontrolled obstructive sleep apnea with symptoms
- On statin therapy with myopathy
- Unstable atrial fibrillation
- Weight pre-body contouring greater than 340 lbs (154 kg)
- Current smoker
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: The Impact of Abdominal Body Contouring Surgery on Physical Function After a Massive Weight Loss: a Non-randomized Control Trial
Obesity is a growing chronic medical condition in which as of 2015, a total of 107.7 million children and 603.7 million adults were considered obese and since 1980 the prevalence of obesity has doubled in more than 70 countries. It is estimated that 70 percent of individuals who undergo a massive weight loss would develop excess skin and based on patient reported outcome measures, it has been shown that excess skin negatively impacts patients' body image, self-esteem, physical function and body contouring surgeries have been demonstrated to improve these measures. These are surgeries that correct for excess skin and its adverse consequences. The form of the surgery is case dependent and can range from removing an apron of skin to complete contouring of the abdomen with tightening of the abdominal muscle and moving the belly button. Despite previous studies indicating mobility limitation because of excess skin and improvements after abdominal body contouring surgeries with the use of subjective measures of physical function, there are no studies that directly measures physical fitness post body contouring surgeries. Therefore, the purpose of the current study is to evaluate the impact of abdominal body contouring surgeries on direct objective measures of physical function.
It is hypothesized that 1) the removal of excess skin will improve direct objective measures of physical function in post massive weight loss participants 2) the removal of excess skin will improve direct measures of gait and balance in post massive weight loss participants 3) the removal of excess skin will improve patient reported outcome measures using quality of life questionnaires in post massive weight loss participants 4) the removal of excess skin will improve aerobic capacity in post massive weight loss participants 5) the removal of excess skin does not change the body composition in post massive weight loss participants.
Read the detailed description
Participants will be recruited through multiple medical clinics and will visit the exercise, nutrition and muscle metabolism lab twice over the course of 8-12 weeks to complete objective and subjective measures of physical function. Each testing session will be conducted by the study investigator and physical function testing will be video recorded to reduce measurer bias. Based on participants' status they will be allocated to either a body contouring intervention group (BCI) or a post massive weight loss matched control (PMWMC). The first testing session would happen preoperatively and second one would happen between 8-12 weeks postoperatively depending on recovery required. Pain levels will be measured both pre and postoperatively using a numerical rating scale (0-10) to ensure adequate recovery.
Outcomes will include a variety of objective measures of physical function including 9-item modified physical performance test (mPPT), 30 second chair stand, timed up and go, stair climbing power, modified agility t-test, star excursion balance test, and 6 minute walk test. A body composition measure consisting of fat mass and fat free mass will also be obtained via dual-energy X-ray absorptiometry. Subjective measures would include 6 components of health related quality of life measure using BODY-Q questionnaire that would include sub scales such as body image, physical function, psychological, sexual, social, and obesity symptoms. Other subjective measure would include rate of perceived exertion which would be measured during each of the objective tests.
Additionally, grade of excess skin would be measured by images provided to the participants and weight of the resected excess skin will be obtained from the operating surgeon at the end of the study.
To obtain demographic history, physical activity level post surgery and to gain feedback for future clinical trial, the participants will also complete a socioeconomic status questionnaire, physical activity questionnaire, and participant experience with research questionnaire.
- Conditions
- Weight Loss, Obesity
- Being tested
- Abdominal Body Contouring
- Keywords
- Panniculectomy, Excess Skin
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Body ContouringProcedure or surgery
These are surgeries that correct for excess skin and its adverse consequences. The surgeries that focus on central area to remove a large hanging pannus is usually called panniculectomies or abdominoplasties; the former is focused on the excision of excess tissue to relieve impairment while the latter is generally considered a cosmetic surgery. The form of the surgery is case dependent and can range from removing apron of skin to complete contouring of the abdomen with tightening of the abdominal muscle and moving the belly button.
| Study group | Role | What they receive |
|---|---|---|
| Experimental/Body Contouring Intervention | These are participants who have self-selected to undergo an abdominal body contouring procedure within the course of the study. Receives: Procedure: Abdominal Body Contouring | |
| Control/Post Massive Weight Loss Matched Control | These are participants who have similar characteristics to the body contouring intervention group, but they will not undergo any surgical procedure during the course of the study. The addition of this matched control group with a similar degree of excess skin but who will not be undergoing body contouring surgery will control for any changes in physical function which may occur without any intervention within the testing sessions. This group will also control for any learning effects between testing sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical function aggregate score
Measured by 9-item modified physical performance test that gives an aggregate score out 36 and comprises of 9 tests pre and post surgery and includes the following:
- Time to complete a book lift
- Time to complete putting on/off a lab coat
- Time to complete picking up a penny from the floor
- Time to complete a 5 times chair stand
- Turning 360 degrees
- Time to complete a 50 feet walk
- Time to complete 1 flight of stairs
- Completing 4 flights of stairs
- A progressive romberg test
Lowest score is 0, highest score is 36 and higher scores represent better outcomes.
Measured: 8-12 weeks
Secondary outcomes (10)
Change in lower body strength
Measured by number of stands completed during a 30 seconds chair stand pre and post surgery
Measured: 8-12 weeks
Change in time to complete agility drill
Measured by time to complete a modified agility t-test pre and post surgery
Measured: 8-12 weeks
Change in timed up and go
Measured by time to complete a timed up and go test
Measured: 8-12 weeks
Change in stair climbing power
Measured by time to ascend 10 stairs and deriving power pre and post surgery
Measured: 8-12 weeks
Change in dynamic balance balance
Measured by star excursion balance test pre and post surgery
Measured: 8-12 weeks
Change in aerobic capacity
Measured by distance traveled during a 6 minute walk test pre and post surgery
Measured: 8-12 weeks
Change in lean body mass
Measured by change in bone free fat mass by using dual-energy X-ray absorptiometry pre and post surgery
Measured: 8-12 weeks
Change in fat mass
Measured by using dual-energy X-ray absorptiometry pre and post surgery
Measured: 8-12 weeks
Change in patient reported outcome measure of physical function and quality of life
Measured by 6 health related quality of life components of BODY-Q questionnaire pre and post surgery. Sub-scales would include body image, physical function, psychological, sexual, social, and obesity/physical symptoms. Each sub-scale will be graded individually, and the raw scores will be converted into a score from 0-100. For body image, physical function, psychological function, sexual, and social function higher scores represent a better outcome
For obesity/physical symptoms, symptoms will be added so that the total number of symptoms experienced would be obtained. Minimum number of symptoms is 0 and maximum is 10.
Measured: 8-12 weeks
Change in rate of perceived exertion (RPE) during physical function tests
Measured by BORG RPE scale pre and post surgery. Minimum score is 6 and maximum is 20. The scale is only to provide how much the participants are being exerted when given a task.
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start18 Aug 2020
- Primary completion29 Dec 2021
- Study completion29 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cameron Mitchell, University of British Columbia
- Investigators
- Cameron Mitchell, PhD, Principal investigator, Assistant Professor University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516473
- Sponsor's protocol ID
- H20-00960
- Acronym
- BCSP
- Status last verified
- Jan 2022
- First submitted
- 13 Aug 2020
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan available for IPD sharing
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Abdominal Body Contouring Surgery on Physical Function After a Massive Weight Loss: a Non-randomized Control Trial
- ClinicalTrials.gov ID
- NCT04516473
- Acronym / sponsor ID
- BCSP / H20-00960
- Conditions
- Weight Loss, Obesity
- Keywords
- Panniculectomy, Excess Skin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 29 Dec 2021 (actual)
- First posted
- 18 Aug 2020 (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.
Obesity is a growing chronic medical condition in which as of 2015, a total of 107.7 million children and 603.7 million adults were considered obese and since 1980 the prevalence of obesity has doubled in more than 70 countries. It is estimated that 70 percent of individuals who undergo a massive weight loss would develop excess skin and based on patient reported outcome measures, it has been shown that excess skin negatively impacts patients' body image, self-esteem, physical function and body contouring surgeries have been demonstrated to improve these measures. These are surgeries that correct for excess skin and its adverse consequences. The form of the surgery is case dependent and can range from removing an apron of skin to complete contouring of the abdomen with tightening of the abdominal muscle and moving the belly button. Despite previous studies indicating mobility limitation because of excess skin and improvements after abdominal body contouring surgeries with the use of subjective measures of physical function, there are no studies that directly measures physical fitness post body contouring surgeries. Therefore, the purpose of the current study is to evaluate the impact of abdominal body contouring surgeries on direct objective measures of physical function.
It is hypothesized that 1) the removal of excess skin will improve direct objective measures of physical function in post massive weight loss participants 2) the removal of excess skin will improve direct measures of gait and balance in post massive weight loss participants 3) the removal of excess skin will improve patient reported outcome measures using quality of life questionnaires in post massive weight loss participants 4) the removal of excess skin will improve aerobic capacity in post massive weight loss participants 5) the removal of excess skin does not change the body composition in post massive weight loss participants.
Detailed description
Participants will be recruited through multiple medical clinics and will visit the exercise, nutrition and muscle metabolism lab twice over the course of 8-12 weeks to complete objective and subjective measures of physical function. Each testing session will be conducted by the study investigator and physical function testing will be video recorded to reduce measurer bias. Based on participants' status they will be allocated to either a body contouring intervention group (BCI) or a post massive weight loss matched control (PMWMC). The first testing session would happen preoperatively and second one would happen between 8-12 weeks postoperatively depending on recovery required. Pain levels will be measured both pre and postoperatively using a numerical rating scale (0-10) to ensure adequate recovery.
Outcomes will include a variety of objective measures of physical function including 9-item modified physical performance test (mPPT), 30 second chair stand, timed up and go, stair climbing power, modified agility t-test, star excursion balance test, and 6 minute walk test. A body composition measure consisting of fat mass and fat free mass will also be obtained via dual-energy X-ray absorptiometry. Subjective measures would include 6 components of health related quality of life measure using BODY-Q questionnaire that would include sub scales such as body image, physical function, psychological, sexual, social, and obesity symptoms. Other subjective measure would include rate of perceived exertion which would be measured during each of the objective tests.
Additionally, grade of excess skin would be measured by images provided to the participants and weight of the resected excess skin will be obtained from the operating surgeon at the end of the study.
To obtain demographic history, physical activity level post surgery and to gain feedback for future clinical trial, the participants will also complete a socioeconomic status questionnaire, physical activity questionnaire, and participant experience with research questionnaire.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental/Body Contouring Intervention | – | Procedure: Abdominal Body ContouringThese are participants who have self-selected to undergo an abdominal body contouring procedure within the course of the study. |
| Control/Post Massive Weight Loss Matched Control | – | –These are participants who have similar characteristics to the body contouring intervention group, but they will not undergo any surgical procedure during the course of the study. The addition of this matched control group with a similar degree of excess skin but who will not be undergoing body contouring surgery will control for any changes in physical function which may occur without any intervention within the testing sessions. This group will also control for any learning effects between testing sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Male and female who have undergone a massive weight loss through any weight loss intervention, have excess skin, are healthy enough to perform simple physical function tasks and self-selected to undergo abdominal skin removal surgery. Participants who have similar criteria to the intervention group but will not undergo surgical intervention during the course of the study will serve as a control group.
Key inclusion criteria (4 listed)
- Weight has not deviated by greater than 5 percent for 3 months
- Have excess grade skin of greater or equal to 2
- Percent total weight loss pre-body contouring of greater or equal to 25 percent
- Fluently read and write English
Key exclusion criteria (13 listed)
- Any musculoskeletal issues that would prevent participants from doing the physical function tests.
- Current medication history indicating atypical antipsychotics including but not limited to clozapine, olanzapine, quetiapine, risperidone, aripiprazole, amisulpride, ziprasidone, asenapine, iloperidone, lurasidone and paliperidone.
- Severe pulmonary conditions such as severe chronic obstructive pulmonary disease (COPD) and or severe asthma.
- Participants who actively aiming to lose weight
- Have diabetes with diabetic neuropathy or experienced hypoglycemic event within 6 months prior to the study
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 |
|---|---|---|
| Abdominal Body ContouringThese are surgeries that correct for excess skin and its adverse consequences. The surgeries that focus on central area to remove a large hanging pannus is usually called panniculectomies or abdominoplasties; the former is focused on the excision of excess tissue to relieve impairment while the latter is generally considered a cosmetic surgery. The form of the surgery is case dependent and can range from removing apron of skin to complete contouring of the abdomen with tightening of the abdominal muscle and moving the belly button. | Procedure or surgery | Experimental/Body Contouring Intervention |
Primary outcome
Change in physical function aggregate score
Time frame: 8-12 weeks
Measured by 9-item modified physical performance test that gives an aggregate score out 36 and comprises of 9 tests pre and post surgery and includes the following: 1. Time to complete a book lift 2. Time to complete putting on/off a lab coat 3. Time to complete picking up a penny from the floor 4. Time to complete a 5 times chair stand 5. Turning 360 degrees 6. Time to complete a 50 feet walk 7. Time to complete 1 flight of stairs 8. Completing 4 flights of stairs 9. A progressive romberg test Lowest score is 0, highest score is 36 and higher scores represent better outcomes.
10 secondary outcomes
Change in lower body strength
Time frame: 8-12 weeks
Change in time to complete agility drill
Time frame: 8-12 weeks
Change in timed up and go
Time frame: 8-12 weeks
Change in stair climbing power
Time frame: 8-12 weeks
Change in dynamic balance balance
Time frame: 8-12 weeks
Change in aerobic capacity
Time frame: 8-12 weeks
Change in lean body mass
Time frame: 8-12 weeks
Change in fat mass
Time frame: 8-12 weeks
Change in patient reported outcome measure of physical function and quality of life
Time frame: 8-12 weeks
Change in rate of perceived exertion (RPE) during physical function tests
Time frame: 8-12 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 20 Jan 2022.
- Individual participant dataSharing planned: No. No plan available for IPD sharing
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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.
Cameron Mitchell, PhD principal investigator
Assistant Professor University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Loss and Obesity, run by University of British Columbia at 1 site in Canada.
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 4 inclusion and 13 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 20 Jan 2022. 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 Canada. 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 physical function aggregate score (time frame: 8-12 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 20 Jan 2022.