ObesityNCT01527851
Excess Skin and Physical Activity
An observational study of Obesity, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Introduction: Currently, bariatric surgery appears to be the most effective treatment to improve the health of morbidly obese population. However, the massive weight loss induced by this intervention can create excess loose skin in various parts of the body contributing to the feeling of failure in their desire to… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obesity
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to 11 Jan 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: A group of 20 people who underwent bariatric surgery and a group of 10 people who underwent bariatric surgery and one or several plastic surgery
Who may be able to join
- have underwent bariatric surgery more than 1 year ago
- had a weight loss of at least 20% after bariatric surgery
- had a weight change of less than 5 kg in the last 3 months
- woman > 18 years old
- have read and given consent
- have underwent a plastic surgery at least 6 months ago
Who cannot join
- medical contraindication for physical activity
- major functional limitations : failure to realize different tests
- intellectual disability and/or neuropsychological disease
- not being able to speak or understand french
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Excess Skin on the Practice of Physical Activity in Women Who Underwent Bariatric Surgery and Exploration of the Benefits of Plastic Surgery
Introduction: Currently, bariatric surgery appears to be the most effective treatment to improve the health of morbidly obese population. However, the massive weight loss induced by this intervention can create excess loose skin in various parts of the body contributing to the feeling of failure in their desire to feel better in some patients. Several studies show that people are once again disappointed and dissatisfied with their body appearance due to the mass of unsightly loose skin that disrupts their quality of life. However, very few studies have focused on the barriers that this excess skin could create in everyday physical activity. The aim of the investigators pilot study is to assess the impact of excess skin on the practice of physical activity in women who underwent bariatric surgery and evaluate if there is a relationship between physical activity and the level and location of excess skin. Also, the investigators will explore, the benefits of plastic surgery in patients who had this intervention.
Materials and methods: About twenty women who underwent bariatric surgery and a dozen who had subsequent plastic surgery will be included in this pilot study. Anthropometry, weight loss post bariatric and plastic surgery, motivational stage on the practice of physical activity, usual practice of physical activity, functional and physical ability, perceived benefits and barriers of physical activity, self-esteem and quality of life will be assessed. After analyzing the results, a group discussion will be established to further evaluate the impact of excess skin on the practice of physical activity. The evaluation will be identical for monitoring the effects of plastic surgery but the discussion group will also address the benefits and satisfaction related to plastic surgery.
Read more
Expected results: Excess skin could be a barrier to physical activity by limiting the functional and physical capacity. Thus, plastic surgery could improve the practice of physical activity with a direct improvement of functional discomfort, the subjects' motivation to be physically active, perceived benefits and barriers to physical activity, self-esteem and quality of life.
Issue project: This pilot project will generate data that will allow us, depending on the relevance of the results, to continue the investigators investigation with a larger cohort.
- Conditions
- Obesity
- Keywords
- Post-bariatric surgery, Excess skin, Physical fitness, Physical activity, Barriers to physical activity, Plastic surgery, Quality of life, Self-esteem
- Medical subject headings
- Obesity, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity pratice
Inconvenience during physical activity
Measured: Initial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completion21 Oct 2014
- Study completion11 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-France Langlois, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527851
- Sponsor's protocol ID
- 11-190
- Status last verified
- Jan 2021
- First submitted
- 1 Feb 2012
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Baillot A, Asselin M, Comeau E, Meziat-Burdin A, Langlois MF. Impact of excess skin from massive weight loss on the practice of physical activity in women. Obes Surg. 2013 Nov;23(11):1826-34. doi: 10.1007/s11695-013-0932-0.
PubMed 23620304
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Excess Skin on the Practice of Physical Activity in Women Who Underwent Bariatric Surgery and Exploration of the Benefits of Plastic Surgery
- ClinicalTrials.gov ID
- NCT01527851
- Acronym / sponsor ID
- 11-190
- Conditions
- Obesity
- Keywords
- Post-bariatric surgery, Excess skin, Physical fitness, Physical activity, Barriers to physical activity, Plastic surgery, Quality of life, Self-esteem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- 21 Oct 2014 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 7 Feb 2012 (estimated)
- 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.
Introduction: Currently, bariatric surgery appears to be the most effective treatment to improve the health of morbidly obese population. However, the massive weight loss induced by this intervention can create excess loose skin in various parts of the body contributing to the feeling of failure in their desire to feel better in some patients. Several studies show that people are once again disappointed and dissatisfied with their body appearance due to the mass of unsightly loose skin that disrupts their quality of life. However, very few studies have focused on the barriers that this excess skin could create in everyday physical activity. The aim of the investigators pilot study is to assess the impact of excess skin on the practice of physical activity in women who underwent bariatric surgery and evaluate if there is a relationship between physical activity and the level and location of excess skin. Also, the investigators will explore, the benefits of plastic surgery in patients who had this intervention.
Materials and methods: About twenty women who underwent bariatric surgery and a dozen who had subsequent plastic surgery will be included in this pilot study. Anthropometry, weight loss post bariatric and plastic surgery, motivational stage on the practice of physical activity, usual practice of physical activity, functional and physical ability, perceived benefits and barriers of physical activity, self-esteem and quality of life will be assessed. After analyzing the results, a group discussion will be established to further evaluate the impact of excess skin on the practice of physical activity. The evaluation will be identical for monitoring the effects of plastic surgery but the discussion group will also address the benefits and satisfaction related to plastic surgery.
Expected results: Excess skin could be a barrier to physical activity by limiting the functional and physical capacity. Thus, plastic surgery could improve the practice of physical activity with a direct improvement of functional discomfort, the subjects' motivation to be physically active, perceived benefits and barriers to physical activity, self-esteem and quality of life.
Issue project: This pilot project will generate data that will allow us, depending on the relevance of the results, to continue the investigators investigation with a larger cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A group of 20 people who underwent bariatric surgery and a group of 10 people who underwent bariatric surgery and one or several plastic surgery
Key inclusion criteria (6 listed)
- have underwent bariatric surgery more than 1 year ago
- had a weight loss of at least 20% after bariatric surgery
- had a weight change of less than 5 kg in the last 3 months
- woman > 18 years old
- have read and given consent
Key exclusion criteria (4 listed)
- medical contraindication for physical activity
- major functional limitations : failure to realize different tests
- intellectual disability and/or neuropsychological disease
- not being able to speak or understand french
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical activity pratice
Time frame: Initial
Inconvenience during physical activity
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 15 Jan 2021.
- Derived from this study: PubMed 23620304Baillot A, Asselin M, Comeau E, Meziat-Burdin A, Langlois MF. Impact of excess skin from massive weight loss on the practice of physical activity in women. Obes Surg. 2013 Nov;23(11):1826-34. doi: 10.1007/s11695-013-0932-0.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Obesity, run by Université de Sherbrooke 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 6 inclusion and 4 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 15 Jan 2021. 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?
Physical activity pratice (time frame: Initial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01527851, which also lists 1 linked publication.
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 15 Jan 2021.