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Outcomes After Weight Loss Surgery in Low-Risk Patients

Primary Purpose

Weight Loss, Bariatric Surgery

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Body Image/Self-Esteem Questionnaires
Sponsored by
Dr. Feiz & Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Weight Loss focused on measuring Outcomes

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.

Sites / Locations

  • Dr. Feiz and AssociatesRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with BMI between 30-34.5 kg/m2

Arm 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.

Outcomes

Primary Outcome Measures

Change in Perception of General Health
A survey will be administered to determine changes in one's self-assessed general health.
Change in Perception of Body Image
Surveys will be administered to determine changes in one's self-assessed body image.
Change in Perception of Quality of Life
Surveys will be administered to determine changes in one's self-assessed quality of life.

Secondary Outcome Measures

Full Information

First Posted
January 16, 2023
Last Updated
January 24, 2023
Sponsor
Dr. Feiz & Associates
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1. Study Identification

Unique Protocol Identification Number
NCT05699083
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2022 (Actual)
Primary Completion Date
January 12, 2025 (Anticipated)
Study Completion Date
January 12, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Feiz & Associates

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Bariatric Surgery
Keywords
Outcomes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-post interventional study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with BMI between 30-34.5 kg/m2
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Body Image/Self-Esteem Questionnaires
Intervention Description
Pre-operation and post-operation questionnaires to assess factors including but not limited to body image, quality of life, and self-esteem.
Primary Outcome Measure Information:
Title
Change in Perception of General Health
Description
A survey will be administered to determine changes in one's self-assessed general health.
Time Frame
0, 1, 3, 6, 12 months
Title
Change in Perception of Body Image
Description
Surveys will be administered to determine changes in one's self-assessed body image.
Time Frame
0, 1, 3, 6, 12 months
Title
Change in Perception of Quality of Life
Description
Surveys will be administered to determine changes in one's self-assessed quality of life.
Time Frame
0, 1, 3, 6, 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Negin Fadaee, BS MPH
Phone
818-326-5515
Email
negin@drfeiz.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Feizbakhsh, MD
Organizational Affiliation
Dr. Feiz and Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Feiz and Associates
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Negin Fadaee, BS MPH
Phone
818-326-5515
Email
negin@drfeiz.com
First Name & Middle Initial & Last Name & Degree
Michael Feizbakhsh, MD

12. IPD Sharing Statement

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Outcomes After Weight Loss Surgery in Low-Risk Patients

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