search
Back to results

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
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Bariatric surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
    search

    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

    We'll reach out to this number within 24 hrs