Obesity, MildBariPredictNCT06480058
Predictors of Bariatric Surgery Weight Loss
An observational study of Obesity, Mild and Obesity, Morbid, run by Kuwait University at 1 site in Kuwait.
Trial summary
The aim of the observational cross-sectional study is to determine the prevalence and correlates of disordered eating among candidates for bariatric surgery in the BariPredict cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Mild, Obesity, Morbid, Diabete Mellitus
- How many people
- 376 participants
- Where
- 1 siteKuwait
- Study dates
- 20 Jun 2023to 10 Jun 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: A cohort of patients attending a bariatric clinic
Who may be able to join
- Obesity BMI > 30 kg/m2
- 18 years and older
Who cannot join
- BMI < 30 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determinants of Eating Disorder Risk in Pre-intervention Bariatric Surgery Candidates.
The aim of the observational cross-sectional study is to determine the prevalence and correlates of disordered eating among candidates for bariatric surgery in the BariPredict cohort.
The study aims to answer the following question on whether the prevalence of disordered eating is higher in individuals that are candidates of bariatric surgery compared to the general population with obesity.
Read the detailed description
Participants referred to Jaber Al Ahmad Al Sabah Hospital, Hawalli, Kuwait, for bariatric surgery were consecutively screened for the study.
A cross-sectional analysis was performed on a subgroup of this cohort with complete baseline data. The analysis investigates the influence of psychological factors associated with obesity before bariatric surgery.
- Conditions
- Obesity, Mild, Obesity, Morbid, Diabete Mellitus, Diabetes Mellitus, Type 2, Eating Disorders
- Keywords
- Obesity, Metabolic disease, Eating disorder, Mental health
- Medical subject headings
- Obesity, Lymphoma, Follicular, Obesity, Morbid, Diabetes Mellitus, Diabetes Mellitus, Type 2, Feeding and Eating Disorders, Metabolic Diseases, Psychological Well-Being
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Screening
A validated SCOFF questionnaire will be self-administered to patients attending their first preoperative bariatric surgery appointment. The SCOFF questionnaire is a simple 5-question test developed to assess the possible presence of an eating disorder. The S in SCOFF stands for "sick" (to vomit). The O stands for "one stone" of weight (i.e., 6.35 kg). The letters C, F and F stand for "control", "fat" and "food" respectively. Although the SCOFF is not used for diagnostic purposes, a score of 2 or more positive answers raises the index of suspicion of eating disorders, highlighting the need for a more detailed psychological history .The SCOFF has been previously validated in Arab populations.
Measured: 1 Day
Secondary outcomes (3)
Anxiety
Kuwait University Anxiety Scale (KUAS)
The Kuwait University Anxiety Scale will be used to measure level of anxiety. The 20-item scale will capture cognitive/affective anxiety (9 items), subjective anxiety or nervousness (7 items), and somatic anxiety (4 items) [4]. Responses use a 4-point Likert scale ranging from 1=rare, 2=sometimes, 3= often, 4= always to measure the level of anxiety . The cut offs to indicate anxiety include 0 - 21 normal, 22 - 42 mild anxiety, 42 - 63 moderate anxiety, 64 - 84 severe anxiety.
Measured: 1 Day
Depression
Beck Inventory
Psychological screening and assessment for anxiety and depression will be carried by a clinical psychologist using a validated questionnaire. The Beck Depression inventory which includes a 21-item multiple choice self-report inventory will be used to measure depressive symptoms within the last week. Each question includes a set of 4 possible choices of how a participant may feel. Choices are scored from 0 to 3, increasing in intensity. The cut-offs to indicate depression include 0 - 9 minimal depression, 10 - 18 mild depression, 19 - 29 moderate depression, 30 - 63 severe depression.
Measured: 1 Day
Obesity
Height and weight will be measured using standard protocols by a qualified nurse during the patient's preoperative and post-operative appointments. Body Mass Index (BMI) will be calculated using WHO cut-off points to define obesity. Obese patients will be divided into different classes of obesity as the following: obese class I (BMI 30 - 34.9 kg/m2), obese class II (35 - 39.9 kg/m2) and obese class III (BMI > 40 kg/m2).
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start20 Jun 2023
- Primary completion10 May 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MildStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 376 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Kuwait University
- Sponsor type
- University, hospital or other
- Collaborators
- Dasman Diabetes Institute, Jaber Al Ahmad Al Sabah Hospital
- Responsible party
- Principal investigator, Dana AlTarrah, Kuwait University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480058
- Sponsor's protocol ID
- 2023/2323
- Other IDs
- 2023/2323
- Acronym
- BariPredict
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Eating Disorder Risk in Pre-intervention Bariatric Surgery Candidates.
- ClinicalTrials.gov ID
- NCT06480058
- Acronym / sponsor ID
- BariPredict / 2023/2323
- Conditions
- Obesity, Mild, Obesity, Morbid, Diabete Mellitus, Diabetes Mellitus, Type 2, Eating Disorders
- Keywords
- Obesity, Metabolic disease, Eating disorder, Mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Kuwait UniversityUniversity, hospital or other
- Collaborators
- Dasman Diabetes Institute, Jaber Al Ahmad Al Sabah Hospital
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 28 Jun 2024 (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 aim of the observational cross-sectional study is to determine the prevalence and correlates of disordered eating among candidates for bariatric surgery in the BariPredict cohort.
The study aims to answer the following question on whether the prevalence of disordered eating is higher in individuals that are candidates of bariatric surgery compared to the general population with obesity.
Detailed description
Participants referred to Jaber Al Ahmad Al Sabah Hospital, Hawalli, Kuwait, for bariatric surgery were consecutively screened for the study.
A cross-sectional analysis was performed on a subgroup of this cohort with complete baseline data. The analysis investigates the influence of psychological factors associated with obesity before bariatric surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A cohort of patients attending a bariatric clinic
Key inclusion criteria (2 listed)
- Obesity BMI > 30 kg/m2
- 18 years and older
Key exclusion criteria (1 listed)
- BMI < 30 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Eating Disorder Screening
Time frame: 1 Day
A validated SCOFF questionnaire will be self-administered to patients attending their first preoperative bariatric surgery appointment. The SCOFF questionnaire is a simple 5-question test developed to assess the possible presence of an eating disorder. The S in SCOFF stands for "sick" (to vomit). The O stands for "one stone" of weight (i.e., 6.35 kg). The letters C, F and F stand for "control", "fat" and "food" respectively. Although the SCOFF is not used for diagnostic purposes, a score of 2 or more positive answers raises the index of suspicion of eating disorders, highlighting the need for a more detailed psychological history .The SCOFF has been previously validated in Arab populations.
3 secondary outcomes
Anxiety
Time frame: 1 Day
Depression
Time frame: 1 Day
Obesity
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Obesity, Mild
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Recruiting
iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) +Optimized Lifestyle Intervention (OLI) vs Sham + OLI for Weight Loss
Overweight and/or Obesity, Metabolic Syndrome
Not yet recruitingPhase 2
Semaglutide, Weight Loss, and LNG-IUD for Conservative Treatment of Endometrial Atypical Hyperplasia and Grade 1 Endometrial Cancer
Endometrial Atypical Hyperplasia, Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia
Not yet recruitingPhase 2
Tirzepatide in Women With Obesity and Endometrial Intra-epithelial Neoplasia or Grade 1 Endometrial Cancer
Endometrial Cancer, Endometrial Intraepithelial Neoplasia
Active, not recruitingPhase 2
A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity
Obesity, Heart Failure With Preserved Ejection Fraction (HFPEF)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Mild and Obesity, Morbid, run by Kuwait University at 1 site in Kuwait.
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 1 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: finished, as of the sponsor's last update on 28 Jun 2024. 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 Kuwait. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Screening (time frame: 1 Day). 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 28 Jun 2024.