Obesity, Obesity, Morbid
Conditions
Keywords
Bariatric surgery
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.
Interventions
PROCEDUREsleeve gastrectomy
sleeve gastrectomy
DEVICEsupport garment
A custom made support garment
Sponsors
Bodynov
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin maceration | From baseline to 12 month following sleeve gastrectomy | maceration evaluated with an in-house questionnaire reported as presence or absence of skin maceration |
| Excess skin | From baseline to 12 month following sleeve gastrectomy | Excess skin measured with the Iglesias scale, scores are from 1 to 5, higher score means a worse excess skin |
| Skin infection | From baseline to 12 month following sleeve gastrectomy | infection evaluated with an in-house questionnaire reported as presence or absence of skin infection |
| Impact of excess skin | From baseline to 12 month following sleeve gastrectomy | 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 | From baseline to 12 month following sleeve gastrectomy | Physical activity evaluated by wearing an activity monitor |
| Lower back pain | From baseline to 12 month following sleeve gastrectomy | 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 | From baseline to 12 month following sleeve gastrectomy | Rosenberg self esteem scale, scores are from 10 to 40, higher score mean a stronger self esteem |
| Self esteem related to physical appearance | From baseline to 12 month following sleeve gastrectomy | 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 | From baseline to 12 month following sleeve gastrectomy | 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. |
| Severity of depression symptoms | From baseline to 12 month following sleeve gastrectomy | Beck Depression Inventory II questionnaire, scores are from 0 to 63, higher score means more severe depressive symptoms. |
| Anxiety | From baseline to 12 month following sleeve gastrectomy | 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 | From baseline to 12 month following sleeve gastrectomy | Social Physique Anxiety Scale, scores are from 12 to 60, higher score means more anxiety |
| Quality of life | From baseline to 12 month following sleeve gastrectomy | 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 | From baseline to 12 month following sleeve gastrectomy | Dyadic adjustment scale, scores are from 0 to 151, higher score indicates a higher level of marital functioning |
| social ideals of physical appearance | From baseline to 12 month following sleeve gastrectomy | 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 | From baseline to 12 month following sleeve gastrectomy | GastroEsophageal Reflux Disease Score, scores are from 0 to 96, higher score indicates worse gastroesophageal reflux symptoms |
| adherence in wearing the support garment | From baseline to 12 month following sleeve gastrectomy | 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 | From baseline to 12 month following sleeve gastrectomy | 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 | From baseline to 12 month following sleeve gastrectomy | body fat composition assessed by impedance |
Countries
Canada
Outcome results
None listed