Outcomes After Weight Loss Surgery in Low-Risk Patients

Dr. Feiz & Associates

Status: Enrolling

Conditions: Weight Loss; Bariatric Surgery

Treatments: Other: Body Image/Self-Esteem Questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT05699083

MF001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Patients with BMI between 30-34.5 kg/m2

Other group

Description:

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.

Treatment:

Other: Body Image/Self-Esteem Questionnaires