Weight LossNCT05699083
Outcomes After Weight Loss Surgery in Low-Risk Patients
A study testing Body Image/Self-Esteem Questionnaires in people with Weight Loss and Bariatric Surgery, run by Dr. Feiz & Associates at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Bariatric Surgery
- What is being tested?
- Body Image/Self-Esteem Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2022to 12 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dr. Feiz and Associates
Beverly Hills, California, 90210
Negin Fadaee, BS MPH, 818-326-5515, negin@drfeiz.com
Michael Feizbakhsh, MD
About this study
Official title: Evaluation of Patient Reported Outcomes After Weight Loss Surgery in Low-Risk Patients
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.
Read the 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.
- Conditions
- Weight Loss, Bariatric Surgery
- Being tested
- Body Image/Self-Esteem Questionnaires
- Keywords
- Outcomes
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Image/Self-Esteem QuestionnairesOther
Pre-operation and post-operation questionnaires to assess factors including but not limited to body image, quality of life, and self-esteem.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Body Image/Self-Esteem Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perception of General Health
A survey will be administered to determine changes in one's self-assessed general health.
Measured: 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.
Measured: 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.
Measured: 0, 1, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start11 Mar 2022
- Primary completion12 Jan 2025 (estimated)
- Study completion12 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post interventional study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Feiz & Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Feizbakhsh, MD, Principal investigator, Dr. Feiz and Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699083
- Sponsor's protocol ID
- MF001
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Reported Outcomes After Weight Loss Surgery in Low-Risk Patients
- ClinicalTrials.gov ID
- NCT05699083
- Acronym / sponsor ID
- MF001
- Conditions
- Weight Loss, Bariatric Surgery
- Keywords
- Outcomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dr. Feiz & AssociatesUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 12 Jan 2025 (estimated)
- Study completion
- 12 Jan 2026 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post interventional study
| Arm | Type | Receives |
|---|---|---|
| Patients with BMI between 30-34.5 kg/m2 | Other | Other: Body Image/Self-Esteem QuestionnairesPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body Image/Self-Esteem QuestionnairesPre-operation and post-operation questionnaires to assess factors including but not limited to body image, quality of life, and self-esteem. | Other | Patients with BMI between 30-34.5 kg/m2 |
Primary outcome
Change in Perception of General Health
Time frame: 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
Time frame: 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
Time frame: 0, 1, 3, 6, 12 months
Surveys will be administered to determine changes in one's self-assessed quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
Related trials for Weight Loss
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Feizbakhsh, MD principal investigator
Dr. Feiz and Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Image/Self-Esteem Questionnaires in people with Weight Loss and Bariatric Surgery, run by Dr. Feiz & Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Negin Fadaee, BS MPH (818-326-5515, negin@drfeiz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perception of General Health (time frame: 0, 1, 3, 6, 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.