Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
Physical activity |
Physical activity evaluated by wearing an activity monitor |
From baseline to 12 month following sleeve gastrectomy |
|
| Primary |
Physical activity |
Global Physical Activity Questionnaire |
From baseline to 12 month following sleeve gastrectomy |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
Body composition |
body fat composition assessed by impedance |
From baseline to 12 month following sleeve gastrectomy |
|
