Outcomes After Weight Loss Surgery in Low-Risk Patients

Not Applicable

Recruiting

• Conditions: Bariatric Surgery; Weight Loss
• Interventions: Other: Body Image/Self-Esteem Questionnaires

• Registration Number: NCT05699083
• Lead Sponsor: Dr. Feiz & Associates

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.

Study Timeline

• Study Start: 2022-03-11
• Status Verified: 2023-01
• Study First Submitted: 2023-01-16
• Study First Submitted QC: 2023-01-24
• Last Update Submitted: 2023-01-24
• Study First Posted: 2023-01-26
• Last Update Posted: 2023-01-26
• Primary Completion: 2025-01-12
• Study Completion: 2026-01-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with BMI between 30-34.5 kg/m2	Body Image/Self-Esteem Questionnaires	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Dr. Feiz and Associates; 🇺🇸 Beverly Hills, California, United States