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Trial registered on ANZCTR
Registration number
ACTRN12622000332729
Ethics application status
Approved
Date submitted
14/04/2021
Date registered
23/02/2022
Date last updated
23/02/2022
Date data sharing statement initially provided
23/02/2022
Date results information initially provided
23/02/2022
Type of registration
Retrospectively registered
Titles & IDs
Public title
Profile Study: Food and eating Problems as a predictor for multidisciplinary follow-up care and patient outcomes post-bariatric surgery an observational cohort study
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Scientific title
Food and eating Problems as a predictor for multidisciplinary follow-up care and patient outcomes post-bariatric surgery an observational cohort study
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Secondary ID [1]
298284
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no secondary id
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Eating behavioural problems
312901
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Condition category
Condition code
Diet and Nutrition
311390
311390
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0
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Obesity
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Surgery
311392
311392
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0
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Other surgery
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
12
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Target follow-up type
Months
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Description of intervention(s) / exposure
The exposure of interest was "Problematic eating behaviours", i.e., food choices, food preparation, eating habits which are associated with negative health outcomes and/or negative nutrient intake.
Problematic eating behaviours were assessed by the multidisciplinary team at a bariatric centre, as part of usual care. These behaviours were recorded in the patients medical record (LapBase, TotalCare, or psychology notes) either descriptively or as part of a standardised checklist. Patients medical records were retrospectively observed for this data.
The problematic eating behaviours were assessed at three time-points: Preoperative, 3-weeks to 6-months postoperative, and 12-months postoperatively.
The exposure of interest was extracted from medical record entries from March 2019 to December 2021.
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Intervention code [1]
314566
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Not applicable
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Comparator / control treatment
N/A
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Total number of adverse events as recorded in medical records.
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Assessment method [1]
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Timepoint [1]
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From day of the procedure up until 12-months post-procedure.
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Secondary outcome [1]
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Body weight change as recorded in medical records.
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Assessment method [1]
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Timepoint [1]
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Assessed at 6 and 12-months post-procedure.
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Secondary outcome [2]
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Lost to follow up as recorded in medical records.
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Assessment method [2]
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Timepoint [2]
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Assessed at 6 and 12-months post-procedure.
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Secondary outcome [3]
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Type of adverse event (coded as surgical, medical, nutritional, or gastrointestinal) as recorded in medical records.
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Assessment method [3]
396745
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Timepoint [3]
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Day of the procedure up until 12-months post-procedure.
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Eligibility
Key inclusion criteria
Eligible participants in the study population will be consecutively sampled adults aged >18 years who underwent: 1) laparoscopic sleeve gastrectomy (LSG), 2) endoscopic sleeve gastroplasty (ESG), 3) intra-gastric balloon (IGB) placement, or 4) medical weight loss therapy (i.e. weight loss medications) at WSLA, Gold Coast. Participants were eligible if they had the procedure performed from 15th March to the 15th March 2020.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants will be excluded if they moved overseas in the 6-months post-procedure or therapy commencement. All participants are eligible and will be included in data collection
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
Sample size has been calculated using the principle ratio of cases to IV where the number of participants required is dependent on the number of predictors in the multiple linear regression calculated as 50 + (8 X number of predictors). As we anticipate the predictors to be: age, work type, sex, number of follow-up appointments and type of procedure (approximate number 5). The sample size required is 50 + (8 X5)=90.
Descriptive variables are: age in years and categorised into (18-35, 36-50 ,51+), type of procedure/intervention (laparoscopic, endoscopic, balloon or medication), comorbidities, existing micronutrient deficiencies (Y/N), gastrointestinal symptoms (Y/N), constipation (Y/N), dumping syndrome (Y/N), diarrhoea (Y/N), pre-surgery food and eating behavioural problems (Y/N), marital status (divorced, single, married, widowed), employment status (employed, unemployed), previous smoker (Y, N), Pre-surgical BMI (kg/m2) as discrete and categorised (30-40, 41-50, 51+), medication (Y, N), mobility (Y, N).
Confounding variables are: smoking (Y, N), surgical complications (Y. N), comorbidities, existing food and eating behavioural problems (Y, N), relocation (Y, N) and holiday (Y,N).Pre-surgical body weight and weight at follow-up appointments is patient reported, recorded in and obtained from medical notes. Age, marital status, employment status, previous smoker will be obtained from patient profile (patient completed demographic questionnaire).
Previous smoker, surgical complications, comorbidities, micronutrient deficiencies, gastrointestinal issues (constipation, diarrhoea, dumping syndrome), medications, mobility, food and eating behavioural problems, attendance at follow up appointments recorded in medical records, GP referral letters, pathology records and psychologists notes. Micronutrient deficiencies will be determined by cut off values in table for diagnosis .
Data will be recorded in different excel spreadsheets. There will be one master spreadsheet for patient id, patient name and age. There will be one spreadsheet for descriptive data. There will be one spreadsheet for outcomes. There will be one spreadsheet for food and eating behavioural problems. Categorical data will be coded in numbers, numerical data will be recorded as numerical.
The data will be analysed using SPSS statistical software.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
27/09/2019
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Date of last participant enrolment
Anticipated
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Actual
2/04/2021
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Date of last data collection
Anticipated
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Actual
2/04/2021
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Sample size
Target
300
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Accrual to date
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Final
292
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment postcode(s) [1]
26578
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4227 - Varsity Lakes
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Funding & Sponsors
Funding source category [1]
302869
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University
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Name [1]
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Bond University
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Address [1]
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Bond Institute of Health and Sport 2 Promethean Way, Robina QLD 4226
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Country [1]
302869
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Australia
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Funding source category [2]
302870
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Commercial sector/Industry
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Name [2]
302870
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Weightloss Solutions Australia
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Address [2]
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Suite 3, Podium Level Lakeside 1, 1 Lake Orr Dr, Varsity Lakes QLD 4227
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Country [2]
302870
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Australia
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Primary sponsor type
University
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Name
Bond Univeristy
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Address
Bond Institute of Health and Sport 2 Promethean Way, Robina QLD 4226
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Country
Australia
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Secondary sponsor category [1]
302821
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Commercial sector/Industry
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Name [1]
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Weightloss Solutions Australia
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Address [1]
302821
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Suite 3, Podium Level Lakeside 1, 1 Lake Orr Dr, Varsity Lakes QLD 4227
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Country [1]
302821
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Bond University
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Ethics committee address [1]
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14 University Dr, Robina QLD 4226
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
303444
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01/07/2019
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Approval date [1]
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12/08/2019
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Ethics approval number [1]
303444
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AM03556
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Summary
Brief summary
A cohort study of patients undergoing a medical intervention for weight loss at a bariatric surgery clinic (laparoscopic sleeve gastrectomy, endoscopic sleeve gastroplasty, intragastric balloon or medication) between March 2019 and March 2020. A food and eating behavioural checklist developed by health professionals at the clinic was used to identify and record problems in the medical checklist. Patient demographic data, outcomes, number of follow-up appointments attended, psychology notes will be accessed via medical records. Data will be analysed to determine whether there is an association between food and eating behavioural problems, adherence to follow-up appointments and adverse events. Results may be used to patient outcomes by improving the multidisciplinary intervention model provided at bariatric surgery clinics.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Skye Marshall
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Address
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Bond University Nutrition & Dietetics Research Group, Faculty of Health Sciences and Medicine, Bond University, 2 Promethean Way, Robina QLD 4226
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Country
39442
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Australia
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Phone
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+61 755954410
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Fax
39442
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Email
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[email protected]
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Contact person for public queries
Name
39443
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Dr Skye Marshall
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Address
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Bond University Nutrition & Dietetics Research Group, Faculty of Health Sciences and Medicine, Bond University, 2 Promethean Way, Robina QLD 4226
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Country
39443
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Australia
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Phone
39443
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+61 755954410
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Fax
39443
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Email
39443
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[email protected]
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Contact person for scientific queries
Name
39444
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Dr Skye Marshall
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Address
39444
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Bond University Nutrition & Dietetics Research Group, Faculty of Health Sciences and Medicine, Bond University, 2 Promethean Way, Robina QLD 4226
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Country
39444
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Australia
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Phone
39444
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+61 755954410
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Fax
39444
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Email
39444
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Association between disordered eating and clinical outcomes following a surgical or endoscopic bariatric procedure: A real-world exploratory study.
2023
https://dx.doi.org/10.1002/osp4.691
N.B. These documents automatically identified may not have been verified by the study sponsor.
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