ObesityNCT04938310
Impact of Wearing a Support Garment Following Parietal Gastrectomy
A study testing sleeve gastrectomy and support garment in people with Obesity and Obesity, Morbid, run by Laval University at 1 site in Canada.
Trial summary
Custom-made orthopedic support equipment and abdominal-lumbar support belts offer promising potential for several aspects affecting the health and well-being of people with obesity who choose a surgical weight loss option. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Obesity, Morbid
- What is being tested?
- sleeve gastrectomy and support garment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 4 Oct 2021to 1 Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meeting the NIH criteria for bariatric surgery
- BMI >= 35 kg/m2
Who cannot join
- chronic pulmonary obstructive disease
- gastric stoma
- psychiatric disease contraindicated for bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Wearing a Support Garment on Mobility, Functional Capacity, Self-esteem, Quality of Life and Skin Maceration Following Parietal Gastrectomy
Custom-made orthopedic support equipment and abdominal-lumbar support belts offer promising potential for several aspects affecting the health and well-being of people with obesity who choose a surgical weight loss option. However, research is needed to quantitatively document their short and long term effects on a wide range of parameters related to mobility, quality of life, lower back pain and skin maceration following parietal gastrectomy. The objective of this study is to characterize the effect of a support garment in an experimental design where a subgroup of participants will be randomized and followed for the first 12 months after a gastrectomy. The measures will be: physical activity, lower back pain, self-esteem, quality of life, skin maceration and infections. This study will scientifically document the usefulness and effectiveness of support garments throughout the weight loss surgery process.
- Conditions
- Obesity, Obesity, Morbid
- Being tested
- sleeve gastrectomy, support garment
- Keywords
- Bariatric surgery
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleeve gastrectomyProcedure or surgery
sleeve gastrectomy
support garmentDevice
A custom made support garment
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Sleeve gastrectomy Receives: Procedure: sleeve gastrectomy |
| Support garment group | Experimental | Sleeve gastrectomy followed by a period of 12-month with a support garment Receives: Procedure: sleeve gastrectomy; Device: support garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excess skin
Excess skin measured with the Iglesias scale, scores are from 1 to 5, higher score means a worse excess skin
Measured: From baseline to 12 month following sleeve gastrectomy
Skin maceration
maceration evaluated with an in-house questionnaire reported as presence or absence of skin maceration
Measured: From baseline to 12 month following sleeve gastrectomy
Skin infection
infection evaluated with an in-house questionnaire reported as presence or absence of skin infection
Measured: From baseline to 12 month following sleeve gastrectomy
Impact of excess skin
Sahlgrenska Excess Skin questionnaire assesses excess skin after weight loss for specific body parts and body as a hole. Inconvenience of excess skin is evaluated on a scale from 0 to 10, higher score means higher perception that the excess skin is an inconvenience.
Measured: From baseline to 12 month following sleeve gastrectomy
Physical activity
Physical activity evaluated by wearing an activity monitor
Measured: From baseline to 12 month following sleeve gastrectomy
Physical activity
Global Physical Activity Questionnaire
Measured: From baseline to 12 month following sleeve gastrectomy
Lower back pain
Quebec back pain scale, scores are from 0 to 100, higher score means greater difficulty in carrying out activities due to low back pain
Measured: From baseline to 12 month following sleeve gastrectomy
Self esteem
Rosenberg self esteem scale, scores are from 10 to 40, higher score mean a stronger self esteem
Measured: From baseline to 12 month following sleeve gastrectomy
Self esteem related to physical appearance
Body Esteem Scale for Adolescent and Adults contains 3 subscales for weight, appearance and attribution. Scores are from 1 to 5, higher score means higher self esteem.
Measured: From baseline to 12 month following sleeve gastrectomy
Body image
Gender-specific body-size guide is a pictorial method of assessing the perception of weight status. It consists of 10 standardized images of adults with known BMI values and is a validated body size perception tool. The scale is gender specific and images range from underweight (BMI <18.5) to class III obesity (BMI> = 40) with approximately a 3 point difference in BMI between the figures on the scale.
Measured: From baseline to 12 month following sleeve gastrectomy
Body image
body shape questionnaire, scores are from 34 to 204, higher score means worse feeling about the appearance.
Measured: From baseline to 12 month following sleeve gastrectomy
Body image
Eating Disorders Examination Questionnaire contains subscales for restraint, eating concern, shape concern and weight concern. Each subscales and global scale scores are form 0 to 6, higher score means worse outcome
Measured: From baseline to 12 month following sleeve gastrectomy
Severity of depression symptoms
Beck Depression Inventory II questionnaire, scores are from 0 to 63, higher score means more severe depressive symptoms.
Measured: From baseline to 12 month following sleeve gastrectomy
Anxiety
State-Trait Anxiety Inventory contains 2 subscales for usual emotional state and current emotional state. Scores are from 20 to 80, higher scores means higher anxiety state.
Measured: From baseline to 12 month following sleeve gastrectomy
Social Physique Anxiety
Social Physique Anxiety Scale, scores are from 12 to 60, higher score means more anxiety
Measured: From baseline to 12 month following sleeve gastrectomy
Quality of life
Laval questionnaire contains 6 subscales for symptoms, activity/mobility, personal hygiene/clothing, emotions, social interactions, and sex life. scores are from 1 to 7, higher score means higher quality of life in each domain
Measured: From baseline to 12 month following sleeve gastrectomy
marital satisfaction
Dyadic adjustment scale, scores are from 0 to 151, higher score indicates a higher level of marital functioning
Measured: From baseline to 12 month following sleeve gastrectomy
social ideals of physical appearance
Sociocultural Attitude Towards Appearance Questionnaire-4 contains 6 subscales (internalization: thinness / low fat mass, internalization: muscular, internalization: general attractiveness, pressures: family, pressures: media, pressures: similar and other significant). Scores are from 1 to 5, higher scores indicating greater internalization and endorsement of societal appearance ideals
Measured: From baseline to 12 month following sleeve gastrectomy
gastroesophageal reflux disease
GastroEsophageal Reflux Disease Score, scores are from 0 to 96, higher score indicates worse gastroesophageal reflux symptoms
Measured: From baseline to 12 month following sleeve gastrectomy
adherence in wearing the support garment
adherence in wearing the support garment evaluated with an adherence journal. Adherence will be calculated as a percentage from the total number of days the participant wears the garment out of the total for the intervention.
Measured: From baseline to 12 month following sleeve gastrectomy
persistence in wearing the support garment
persistence in wearing the support garment will be calculated as a percentage by reporting the number of participants who have stopped wearing the garment compared to those who have used it.
Measured: From baseline to 12 month following sleeve gastrectomy
Body composition
body fat composition assessed by impedance
Measured: From baseline to 12 month following sleeve gastrectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start4 Oct 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Why it stopped: Study stopped prematurely by sponsor due to lack of funding following company closure
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 Laval UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Bodynov, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Responsible party
- Principal investigator, Laurent Biertho, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938310
- Sponsor's protocol ID
- Bodynov
- Status last verified
- Aug 2025
- First submitted
- 28 May 2021
- Last updated
- 8 Aug 2025
- 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 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Wearing a Support Garment on Mobility, Functional Capacity, Self-esteem, Quality of Life and Skin Maceration Following Parietal Gastrectomy
- ClinicalTrials.gov ID
- NCT04938310
- Acronym / sponsor ID
- Bodynov
- Conditions
- Obesity, Obesity, Morbid
- Keywords
- Bariatric surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped prematurely by sponsor due to lack of funding following company closure
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Bodynov, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 24 Jun 2021 (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.
Custom-made orthopedic support equipment and abdominal-lumbar support belts offer promising potential for several aspects affecting the health and well-being of people with obesity who choose a surgical weight loss option. However, research is needed to quantitatively document their short and long term effects on a wide range of parameters related to mobility, quality of life, lower back pain and skin maceration following parietal gastrectomy. The objective of this study is to characterize the effect of a support garment in an experimental design where a subgroup of participants will be randomized and followed for the first 12 months after a gastrectomy. The measures will be: physical activity, lower back pain, self-esteem, quality of life, skin maceration and infections. This study will scientifically document the usefulness and effectiveness of support garments throughout the weight loss surgery process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: sleeve gastrectomySleeve gastrectomy |
| Support garment group | Experimental | Procedure: sleeve gastrectomy, Device: support garmentSleeve gastrectomy followed by a period of 12-month with a support garment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- meeting the NIH criteria for bariatric surgery
- BMI >= 35 kg/m2
Key exclusion criteria (3 listed)
- chronic pulmonary obstructive disease
- gastric stoma
- psychiatric disease contraindicated for bariatric surgery
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 |
|---|---|---|
| sleeve gastrectomysleeve gastrectomy | Procedure or surgery | Control Group, Support garment group |
| support garmentA custom made support garment | Device | Support garment group |
Primary outcome
Excess skin
Time frame: From baseline to 12 month following sleeve gastrectomy
Excess skin measured with the Iglesias scale, scores are from 1 to 5, higher score means a worse excess skin
Skin maceration
Time frame: From baseline to 12 month following sleeve gastrectomy
maceration evaluated with an in-house questionnaire reported as presence or absence of skin maceration
Skin infection
Time frame: From baseline to 12 month following sleeve gastrectomy
infection evaluated with an in-house questionnaire reported as presence or absence of skin infection
Impact of excess skin
Time frame: From baseline to 12 month following sleeve gastrectomy
Sahlgrenska Excess Skin questionnaire assesses excess skin after weight loss for specific body parts and body as a hole. Inconvenience of excess skin is evaluated on a scale from 0 to 10, higher score means higher perception that the excess skin is an inconvenience.
Physical activity
Time frame: From baseline to 12 month following sleeve gastrectomy
Physical activity evaluated by wearing an activity monitor
Physical activity
Time frame: From baseline to 12 month following sleeve gastrectomy
Global Physical Activity Questionnaire
Lower back pain
Time frame: From baseline to 12 month following sleeve gastrectomy
Quebec back pain scale, scores are from 0 to 100, higher score means greater difficulty in carrying out activities due to low back pain
Self esteem
Time frame: From baseline to 12 month following sleeve gastrectomy
Rosenberg self esteem scale, scores are from 10 to 40, higher score mean a stronger self esteem
Self esteem related to physical appearance
Time frame: From baseline to 12 month following sleeve gastrectomy
Body Esteem Scale for Adolescent and Adults contains 3 subscales for weight, appearance and attribution. Scores are from 1 to 5, higher score means higher self esteem.
Body image
Time frame: From baseline to 12 month following sleeve gastrectomy
Gender-specific body-size guide is a pictorial method of assessing the perception of weight status. It consists of 10 standardized images of adults with known BMI values and is a validated body size perception tool. The scale is gender specific and images range from underweight (BMI <18.5) to class III obesity (BMI> = 40) with approximately a 3 point difference in BMI between the figures on the scale.
Body image
Time frame: From baseline to 12 month following sleeve gastrectomy
body shape questionnaire, scores are from 34 to 204, higher score means worse feeling about the appearance.
Body image
Time frame: From baseline to 12 month following sleeve gastrectomy
Eating Disorders Examination Questionnaire contains subscales for restraint, eating concern, shape concern and weight concern. Each subscales and global scale scores are form 0 to 6, higher score means worse outcome
Severity of depression symptoms
Time frame: From baseline to 12 month following sleeve gastrectomy
Beck Depression Inventory II questionnaire, scores are from 0 to 63, higher score means more severe depressive symptoms.
Anxiety
Time frame: From baseline to 12 month following sleeve gastrectomy
State-Trait Anxiety Inventory contains 2 subscales for usual emotional state and current emotional state. Scores are from 20 to 80, higher scores means higher anxiety state.
Social Physique Anxiety
Time frame: From baseline to 12 month following sleeve gastrectomy
Social Physique Anxiety Scale, scores are from 12 to 60, higher score means more anxiety
Quality of life
Time frame: From baseline to 12 month following sleeve gastrectomy
Laval questionnaire contains 6 subscales for symptoms, activity/mobility, personal hygiene/clothing, emotions, social interactions, and sex life. scores are from 1 to 7, higher score means higher quality of life in each domain
marital satisfaction
Time frame: From baseline to 12 month following sleeve gastrectomy
Dyadic adjustment scale, scores are from 0 to 151, higher score indicates a higher level of marital functioning
social ideals of physical appearance
Time frame: From baseline to 12 month following sleeve gastrectomy
Sociocultural Attitude Towards Appearance Questionnaire-4 contains 6 subscales (internalization: thinness / low fat mass, internalization: muscular, internalization: general attractiveness, pressures: family, pressures: media, pressures: similar and other significant). Scores are from 1 to 5, higher scores indicating greater internalization and endorsement of societal appearance ideals
gastroesophageal reflux disease
Time frame: From baseline to 12 month following sleeve gastrectomy
GastroEsophageal Reflux Disease Score, scores are from 0 to 96, higher score indicates worse gastroesophageal reflux symptoms
adherence in wearing the support garment
Time frame: From baseline to 12 month following sleeve gastrectomy
adherence in wearing the support garment evaluated with an adherence journal. Adherence will be calculated as a percentage from the total number of days the participant wears the garment out of the total for the intervention.
persistence in wearing the support garment
Time frame: From baseline to 12 month following sleeve gastrectomy
persistence in wearing the support garment will be calculated as a percentage by reporting the number of participants who have stopped wearing the garment compared to those who have used it.
Body composition
Time frame: From baseline to 12 month following sleeve gastrectomy
body fat composition assessed by impedance
Results and safety
The study was stopped early (reason given: Study stopped prematurely by sponsor due to lack of funding following company closure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
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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?
A study testing sleeve gastrectomy and support garment in people with Obesity and Obesity, Morbid, run by Laval University 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 2 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: stopped early, as of the sponsor's last update on 8 Aug 2025. 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 was stopped early (reason given: Study stopped prematurely by sponsor due to lack of funding following company closure). Results are not available in the source record.
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?
Excess skin (time frame: From baseline to 12 month following sleeve gastrectomy). The study lists 22 primary outcomes in all. 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 8 Aug 2025.