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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
sleeve gastrectomy
A custom made support garment
Criucpq-Ul
Québec, Quebec, Canada
Excess skin
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
Skin maceration
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
Skin infection
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
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.
Time frame: From baseline to 12 month following sleeve gastrectomy
Physical activity
Physical activity evaluated by wearing an activity monitor
Time frame: From baseline to 12 month following sleeve gastrectomy
Physical activity
Global Physical Activity Questionnaire
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 12 month following sleeve gastrectomy
Body composition
body fat composition assessed by impedance
Time frame: From baseline to 12 month following sleeve gastrectomy
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