Impact of Wearing a Support Garment Following Parietal Gastrectomy
Primary Purpose
Obesity, Obesity, Morbid
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sleeve gastrectomy
support garment
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Bariatric surgery
Eligibility Criteria
Inclusion Criteria:
- meeting the NIH criteria for bariatric surgery
- BMI >= 35 kg/m2
Exclusion Criteria:
- chronic pulmonary obstructive disease
- gastric stoma
- psychiatric disease contraindicated for bariatric surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Support garment group
Arm Description
Sleeve gastrectomy
Sleeve gastrectomy followed by a period of 12-month with a support garment
Outcomes
Primary Outcome Measures
Excess skin
Excess skin measured with the Iglesias scale, scores are from 1 to 5, higher score means a worse excess skin
Skin maceration
maceration evaluated with an in-house questionnaire reported as presence or absence of skin maceration
Skin infection
infection evaluated with an in-house questionnaire reported as presence or absence of skin infection
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.
Physical activity
Physical activity evaluated by wearing an activity monitor
Physical activity
Global Physical Activity Questionnaire
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
Self esteem
Rosenberg self esteem scale, scores are from 10 to 40, higher score mean a stronger self esteem
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.
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.
Body image
body shape questionnaire, scores are from 34 to 204, higher score means worse feeling about the appearance.
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
Severity of depression symptoms
Beck Depression Inventory II questionnaire, scores are from 0 to 63, higher score means more severe depressive symptoms.
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.
Social Physique Anxiety
Social Physique Anxiety Scale, scores are from 12 to 60, higher score means more anxiety
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
marital satisfaction
Dyadic adjustment scale, scores are from 0 to 151, higher score indicates a higher level of marital functioning
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
gastroesophageal reflux disease
GastroEsophageal Reflux Disease Score, scores are from 0 to 96, higher score indicates worse gastroesophageal reflux symptoms
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.
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.
Body composition
body fat composition assessed by impedance
Secondary Outcome Measures
Full Information
NCT ID
NCT04938310
First Posted
May 28, 2021
Last Updated
June 16, 2021
Sponsor
Laval University
Collaborators
Bodynov, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
1. Study Identification
Unique Protocol Identification Number
NCT04938310
Brief Title
Impact of Wearing a Support Garment Following Parietal Gastrectomy
Official Title
Impact of Wearing a Support Garment on Mobility, Functional Capacity, Self-esteem, Quality of Life and Skin Maceration Following Parietal Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Bodynov, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Obesity, Morbid
Keywords
Bariatric surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Sleeve gastrectomy
Arm Title
Support garment group
Arm Type
Experimental
Arm Description
Sleeve gastrectomy followed by a period of 12-month with a support garment
Intervention Type
Procedure
Intervention Name(s)
sleeve gastrectomy
Intervention Description
sleeve gastrectomy
Intervention Type
Device
Intervention Name(s)
support garment
Intervention Description
A custom made support garment
Primary Outcome Measure Information:
Title
Excess skin
Description
Excess skin measured with the Iglesias scale, scores are from 1 to 5, higher score means a worse excess skin
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
Skin maceration
Description
maceration evaluated with an in-house questionnaire reported as presence or absence of skin maceration
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
Skin infection
Description
infection evaluated with an in-house questionnaire reported as presence or absence of skin infection
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
Impact of excess skin
Description
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.
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
Physical activity
Description
Physical activity evaluated by wearing an activity monitor
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
Physical activity
Description
Global Physical Activity Questionnaire
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
Lower back pain
Description
Quebec back pain scale, scores are from 0 to 100, higher score means greater difficulty in carrying out activities due to low back pain
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
Self esteem
Description
Rosenberg self esteem scale, scores are from 10 to 40, higher score mean a stronger self esteem
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
Self esteem related to physical appearance
Description
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.
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
Body image
Description
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.
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
Body image
Description
body shape questionnaire, scores are from 34 to 204, higher score means worse feeling about the appearance.
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
Body image
Description
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
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
Severity of depression symptoms
Description
Beck Depression Inventory II questionnaire, scores are from 0 to 63, higher score means more severe depressive symptoms.
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
Anxiety
Description
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.
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
Social Physique Anxiety
Description
Social Physique Anxiety Scale, scores are from 12 to 60, higher score means more anxiety
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
Quality of life
Description
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
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
marital satisfaction
Description
Dyadic adjustment scale, scores are from 0 to 151, higher score indicates a higher level of marital functioning
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
social ideals of physical appearance
Description
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
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
gastroesophageal reflux disease
Description
GastroEsophageal Reflux Disease Score, scores are from 0 to 96, higher score indicates worse gastroesophageal reflux symptoms
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
adherence in wearing the support garment
Description
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.
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
persistence in wearing the support garment
Description
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.
Time Frame
From baseline to 12 month following sleeve gastrectomy
Title
Body composition
Description
body fat composition assessed by impedance
Time Frame
From baseline to 12 month following sleeve gastrectomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
meeting the NIH criteria for bariatric surgery
BMI >= 35 kg/m2
Exclusion Criteria:
chronic pulmonary obstructive disease
gastric stoma
psychiatric disease contraindicated for bariatric surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mélanie Nadeau, MSc
Phone
418-656-8711
Ext
3490
Email
melanie.nadeau@criucpq.ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mélissa Pelletier, MSc
Phone
418-656-8711
Ext
2136
Email
melissa.pelletier@criucpq.ulaval.ca
12. IPD Sharing Statement
Learn more about this trial
Impact of Wearing a Support Garment Following Parietal Gastrectomy
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