Impact of Wearing a Support Garment Following Parietal Gastrectomy

NCT04938310 | Terminated

• 1 other identifier: Bodynov
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Obesity, Morbid

Keywords

Bariatric surgery

Outcome Measures

Primary Outcomes (22)

• Excess skin

  Excess skin measured with the Iglesias scale, scores are from 1 to 5, higher score means a worse excess skin

  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

  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

  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.

  From baseline to 12 month following sleeve gastrectomy

• Physical activity

  Physical activity evaluated by wearing an activity monitor

  From baseline to 12 month following sleeve gastrectomy

• Physical activity

  Global Physical Activity Questionnaire

  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

  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

  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.

  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.

  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.

  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

  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.

  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.

  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

  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

  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

  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

  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

  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.

  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.

  From baseline to 12 month following sleeve gastrectomy

• Body composition

  body fat composition assessed by impedance

  From baseline to 12 month following sleeve gastrectomy

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Sleeve gastrectomy

Procedure: sleeve gastrectomy

Support garment group

EXPERIMENTAL

Sleeve gastrectomy followed by a period of 12-month with a support garment

Procedure: sleeve gastrectomy; Device: support garment

Interventions

sleeve gastrectomy PROCEDURE

sleeve gastrectomy

Control Group; Support garment group

support garment DEVICE

A custom made support garment

Support garment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• meeting the NIH criteria for bariatric surgery
• BMI \>= 35 kg/m2

You may not qualify if:

• chronic pulmonary obstructive disease
• gastric stoma
• psychiatric disease contraindicated for bariatric surgery

Sponsors & Collaborators

• Laval University: lead
• Bodynov: collaborator
• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: collaborator

Study Sites (1)

Criucpq-Ul

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 24, 2021
• Study Start: October 4, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

CA (1)