Predictors of Bariatric Surgery Weight Loss (BariPredict)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Obesity, Morbid; Diabete Mellitus; Eating Disorders; Obesity, Mild

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 Type: Observational
• Enrollment (Actual): 376

Contacts and Locations

Study Locations

• Kuwait
  • Kuwait, Kuwait, P.O. Box 24923, Safa
    • Dana AlTarrah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

A cohort of patients attending a bariatric clinic

Description

Inclusion Criteria:

• Obesity BMI > 30 kg/m2
• 18 years and older

Exclusion Criteria:

• BMI < 30 kg/m2

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	1 Day

Collaborators and Investigators

• Sponsor: Kuwait University
• Collaborators: Dasman Diabetes Institute; Jaber Al Ahmad Al Sabah Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Actual): May 10, 2024
• Study Completion (Actual): June 10, 2024

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Mental health; Eating disorder; Metabolic disease
• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity; Feeding and Eating Disorders; Obesity, Morbid
• Other Study ID Numbers: 2023/2323 (Other Identifier: Ministry of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No