Outcomes After Weight Loss Surgery in Low-Risk Patients

Study Overview
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Brief Summary
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The purpose of this research is to determine patient-reported outcomes after weight loss surgery, including changes in health, mood, quality of life, health satisfaction, and emotional health, in low-risk patients. Weight loss surgery has been well studied for patients with body mass index (BMI) 35 kg/m^2 or more and those with weight-related medical problems who have a BMI 30 kg/m^2 or more. However, outcomes after weight loss surgery in patients with BMI under 35 kg/m^2 and without co-morbidities have not been well studied.

Detailed Description
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The purpose of this research is to determine patient-reported outcomes after weight loss surgery in low-risk patients. Weight loss surgery has been well-studied for patients with body mass index (BMI) 35 kg/m^2 or more and those with weight-related medical problems who have a BMI 30 kg/m^2 or more. Weight-related medical problems, also called co-morbidities, can include diabetes mellitus, hypertension, sleep apnea, and degenerative joint diseases. The surgery is considered safe and effective. Outcomes after weight loss surgery in patients with BMI under 35 kg/m^2 and without co-morbidities have not been well studied. The investigators' purpose is to study patient-reported outcomes after weight loss surgery in patients with BMI between 30 kg/m^2 and 34.5 kg/m^2 without co-morbidities. These include changes in health, mood, quality of life, health satisfaction, and emotional health.

Official Title
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Evaluation of Patient Reported Outcomes After Weight Loss Surgery in Low-Risk Patients

Conditions
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Weight Loss, Bariatric Surgery

Intervention / Treatment
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* Other: Body Image/Self-Esteem Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with BMI between 30 kg/m2 and 34.5 kg/m2 without co-morbidities who are medically cleared to undergo cosmetic weight loss surgery. Written informed consent obtained from the subject or the subject's legal representative and the ability for the subject to comply with the requirements of the study. Exclusion Criteria: Patients who are pregnant. Patients with BMI below 30 kg/m2. Patients with BMI above 34.5 kg/m2. Patients who have co-morbidities including, but not limited to, diabetes mellitus, hypertension, sleep apnea, and degenerative joint disease. Patients who are not medically cleared to undergo weight loss surgery.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Pre-post interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with BMI between 30-34.5 kg/m2<br>Patients with BMI between 30-34.5 kg/m2 will be administered a body image/self-esteem questionnaire pre-operatively and at 1 month, 3 months, 6 months and 12 months post-operatively. | Other: Body Image/Self-Esteem Questionnaires<br>* Pre-operation and post-operation questionnaires to assess factors including but not limited to body image, quality of life, and self-esteem.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perception of General Health | A survey will be administered to determine changes in one's self-assessed general health. | 0, 1, 3, 6, 12 months | 
| Change in Perception of Body Image | Surveys will be administered to determine changes in one's self-assessed body image. | 0, 1, 3, 6, 12 months | 
| Change in Perception of Quality of Life | Surveys will be administered to determine changes in one's self-assessed quality of life. | 0, 1, 3, 6, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Outcomes