Outcomes After Weight Loss Surgery in Low-Risk Patients

NCT05699083 | Unknown

• 1 other identifier: MF001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; Bariatric Surgery

Keywords

Outcomes

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Patients with BMI between 30-34.5 kg/m2

OTHER

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

Interventions

Body Image/Self-Esteem Questionnaires OTHER

Pre-operation and post-operation questionnaires to assess factors including but not limited to body image, quality of life, and self-esteem.

Patients with BMI between 30-34.5 kg/m2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Feiz & Associates: lead

Study Sites (1)

Dr. Feiz and Associates

Beverly Hills, California, 90210, United States

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Feizbakhsh, MD

  Dr. Feiz and Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Negin Fadaee, BS MPH

CONTACT

818-326-5515; negin@drfeiz.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-post interventional study

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 26, 2023
• Study Start: March 11, 2022
• Primary Completion: January 12, 2025
• Study Completion: January 12, 2026
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

US (1)