Clinical trial NCT05699083: Outcomes After Weight Loss Surgery in Low-Risk Patients
Official title: Evaluation of Patient Reported Outcomes After Weight Loss Surgery in Low-Risk Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Weight Loss
Bariatric Surgery
Keywords: Outcomes
Lead sponsor: Dr. Feiz & Associates
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post interventional study
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Perception of General Health
timeFrame: 0, 1, 3, 6, 12 months
measure: Change in Perception of Body Image
timeFrame: 0, 1, 3, 6, 12 months
measure: Change in Perception of Quality of Life
timeFrame: 0, 1, 3, 6, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Dr. Feiz and Associates
state: California
Study officials:
affiliation: Dr. Feiz and Associates
name: Michael Feizbakhsh, MD
role: PRINCIPAL_INVESTIGATOR
References: