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Study stopped prematurely by sponsor due to lack of funding following company closure
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| Name | Class |
|---|---|
| Bodynov | UNKNOWN |
| Institut universitaire de cardiologie et de pneumologie de Québec, University Laval | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Sleeve gastrectomy |
|
| Support garment group | Experimental | Sleeve gastrectomy followed by a period of 12-month with a support garment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sleeve gastrectomy | Procedure | sleeve gastrectomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Criucpq-Ul | Québec | Quebec | G1V 4G5 | Canada |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| support garment |
| Device |
A custom made support garment |
|
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |