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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
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
Scientific title
Food and eating Problems as a predictor for multidisciplinary follow-up care and patient outcomes post-bariatric surgery an observational cohort study
Secondary ID [1] 298284 0
no secondary id
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating behavioural problems 312901 0
Condition category
Condition code
Diet and Nutrition 311390 311390 0 0
Obesity
Surgery 311392 311392 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Months
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.
Intervention code [1] 314566 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320181 0
Total number of adverse events as recorded in medical records.
Timepoint [1] 320181 0
From day of the procedure up until 12-months post-procedure.
Secondary outcome [1] 370785 0
Body weight change as recorded in medical records.
Timepoint [1] 370785 0
Assessed at 6 and 12-months post-procedure.
Secondary outcome [2] 396744 0
Lost to follow up as recorded in medical records.
Timepoint [2] 396744 0
Assessed at 6 and 12-months post-procedure.
Secondary outcome [3] 396745 0
Type of adverse event (coded as surgical, medical, nutritional, or gastrointestinal) as recorded in medical records.
Timepoint [3] 396745 0
Day of the procedure up until 12-months post-procedure.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/09/2019
Date of last participant enrolment
Anticipated
Actual
2/04/2021
Date of last data collection
Anticipated
Actual
2/04/2021
Sample size
Target
300
Accrual to date
Final
292
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 26578 0
4227 - Varsity Lakes

Funding & Sponsors
Funding source category [1] 302869 0
University
Name [1] 302869 0
Bond University
Country [1] 302869 0
Australia
Funding source category [2] 302870 0
Commercial sector/Industry
Name [2] 302870 0
Weightloss Solutions Australia
Country [2] 302870 0
Australia
Primary sponsor type
University
Name
Bond Univeristy
Address
Bond Institute of Health and Sport 2 Promethean Way, Robina QLD 4226
Country
Australia
Secondary sponsor category [1] 302821 0
Commercial sector/Industry
Name [1] 302821 0
Weightloss Solutions Australia
Address [1] 302821 0
Suite 3, Podium Level Lakeside 1, 1 Lake Orr Dr, Varsity Lakes QLD 4227
Country [1] 302821 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303444 0
Bond University
Ethics committee address [1] 303444 0
Ethics committee country [1] 303444 0
Australia
Date submitted for ethics approval [1] 303444 0
01/07/2019
Approval date [1] 303444 0
12/08/2019
Ethics approval number [1] 303444 0
AM03556

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39442 0
Dr Skye Marshall
Address 39442 0
Bond University Nutrition & Dietetics Research Group, Faculty of Health Sciences and Medicine, Bond University, 2 Promethean Way, Robina QLD 4226
Country 39442 0
Australia
Phone 39442 0
+61 755954410
Fax 39442 0
Email 39442 0
[email protected]
Contact person for public queries
Name 39443 0
Skye Marshall
Address 39443 0
Bond University Nutrition & Dietetics Research Group, Faculty of Health Sciences and Medicine, Bond University, 2 Promethean Way, Robina QLD 4226
Country 39443 0
Australia
Phone 39443 0
+61 755954410
Fax 39443 0
Email 39443 0
[email protected]
Contact person for scientific queries
Name 39444 0
Skye Marshall
Address 39444 0
Bond University Nutrition & Dietetics Research Group, Faculty of Health Sciences and Medicine, Bond University, 2 Promethean Way, Robina QLD 4226
Country 39444 0
Australia
Phone 39444 0
+61 755954410
Fax 39444 0
Email 39444 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseAssociation between disordered eating and clinical outcomes following a surgical or endoscopic bariatric procedure: A real-world exploratory study.2023https://dx.doi.org/10.1002/osp4.691
N.B. These documents automatically identified may not have been verified by the study sponsor.