Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000868684
Ethics application status
Approved
Date submitted
28/06/2023
Date registered
14/08/2023
Date last updated
28/07/2024
Date data sharing statement initially provided
14/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring the effects of bariatric surgery on mood and well-being
Scientific title
Exploring the effects of bariatric surgery on quality of life, psychological well-being, depression, substance use and alcohol sensitivity
Secondary ID [1] 309542 0
Nil Known
Universal Trial Number (UTN)
U1111-1293-2915
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 329827 0
Bariatric surgery 331023 0
Depression 331024 0
Eating disorder 331025 0
Substance abuse 331026 0
Alcohol abuse 331027 0
Condition category
Condition code
Surgery 326723 326723 0 0
Other surgery
Mental Health 326725 326725 0 0
Depression
Mental Health 326726 326726 0 0
Eating disorders
Mental Health 326727 326727 0 0
Other mental health disorders
Mental Health 326728 326728 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Bariatric Surgery

Any currently approved bariatric procedure performed in the treatment of obesity. This will consist primarily of Sleeve Gastrectomy and Roux-en-Y gastric bypass procedures but may also include One-Anastamosis Gastric Bypass (OAGB), SADI, and gastric band procedures.

Procedures will be performed by bariatric surgeons at their preferred hospital site(s). Surgeons will primarily be those contributing to the Australian and Aotearoa New Zealand Bariatric Surgery Registry.

Procedure type will be chosen by the patient and their surgeon. Patients will be undergoing bariatric surgery regardless of their involvement in this study.

Participants will be asked to complete a series of questionniares via an online platform (REDCap) at baseline and at 2, 12, 24 weeks, 1, 2, and 3 years post-surgery. All questionnaires will be delivered online, with participant contact being made by their nominated method (email, mail, or phone call). This includes the following questionnaires:
- The BODY-Q scales (body image, physcial function, psychological function, social function, expectations: weight loss, eating behvaiour, eating-related distress, eating-related symptoms, satisfaction with surgeon, and satisfaction with information), which will take approximately 40 minutes to complete;
- The PROMIS-D scale, taking approximately 5 minutes to complete;
- The modified Yale Food Addiction Scale (mYFAS 2,0), taking approximately 5 minutes to complete;
- The Alcohol, Smoking, & Substance Involvement Screening Test (ASSIST), Screening Question 2 only, taking 1 minute to complete;
- The Alcohol Use Disorders Identification Test (AUDIT), taking approximately 10 minutes to complete;
- The Drug Use Disorders Identification Test (DUDIT), taking approximately 10 minutes to complete; and
- The Alcohol Sensitivity Questionniare (ASQ), taking approximately 10 minutes to complete.

Patients will undergo their primary procedure at enrolment. Any subsequent procedures/revisions will be captured during follow-up. All participants will be followed for 3 years following their primary procedure.
Intervention code [1] 325968 0
Early Detection / Screening
Intervention code [2] 326692 0
Diagnosis / Prognosis
Comparator / control treatment
Non-Bariatric Upper-Gastrointestinal Surgery

Individuals undergoing hiatus hernia repair. Participants will be undergoing a hiatus hernia repair regardless of their involvement in this study.
Procedures will be performed by general/bariatric surgeons at their preferred hospital site(s). Surgeons recruiting pre-surgical bariatric patients will also recruit control patients and will perfom both procedures.

Participants will be asked to complete a series of questionniares via an online platform (REDCap) at baseline and at 2, 12, 24 weeks, 1, 2, and 3 years post-surgery. All questionnaires will be delivered online, with participant contact being made by their nominated method (email, mail, or phone call). This includes the following questionnaires:
- The BODY-Q scales (body image, physcial function, psychological function, social function, expectations: weight loss, eating behvaiour, eating-related distress, eating-related symptoms, satisfaction with surgeon, and satisfaction with information), which will take approximately 40 minutes to complete;
- The PROMIS-D scale, taking approximately 5 minutes to complete;
- The modified Yale Food Addiction Scale (mYFAS 2,0), taking approximately 5 minutes to complete;
- The Alcohol, Smoking, & Substance Involvement Screening Test (ASSIST), Screening Question 2 only, taking 1 minute to complete;
- The Alcohol Use Disorders Identification Test (AUDIT), taking approximately 10 minutes to complete;
- The Drug Use Disorders Identification Test (DUDIT), taking approximately 10 minutes to complete; and
- The Alcohol Sensitivity Questionniare (ASQ), taking approximately 10 minutes to complete.

Patients will undergo their primary procedure at enrolment. Any subsequent procedures/revisions will be captured during follow-up. All participants will be followed for 3 years following their primary procedure.
Control group
Active

Outcomes
Primary outcome [1] 334592 0
Change in Health-Related Quality of Life assessed by the BODY-Q (Body Image, Physical Function, Psychological function, Social Function)
Timepoint [1] 334592 0
Baseline, 2 weeks, 12 weeks, 24 weeks, 1 year, 2 years, and 3 years post-surgery
Primary outcome [2] 334727 0
Change in depression score assessed by PROMIS-D 8a
Timepoint [2] 334727 0
Baseline, 2 weeks, 12 weeks, 24 weeks, 1 year, 2 years, and 3 years post-surgery
Secondary outcome [1] 421877 0
Change in alcohol use assessed by the Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) [Screening Q2 only] and the Alcohol Use Disorders Identification Test (AUDIT)

This will be assessed as a composite outcome
Timepoint [1] 421877 0
Baseline, 2 weeks, 12 weeks, 24 weeks, 1 year, 2 years, and 3 years post-surgery
Secondary outcome [2] 421879 0
Change in Alcohol Sensitivity assessed by the Alcohol Sensitivity Questionniare (ASQ)
Timepoint [2] 421879 0
Baseline, 2 weeks, 12 weeks, 24 weeks, 1 year, 2 years, and 3 years post-surgery
Secondary outcome [3] 421880 0
Change in drug use assessed by the Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) [Screening Q2 only] and the Drug Use Disorders Identification Test (DUDIT)

This will be assessed as a composite outcome
Timepoint [3] 421880 0
Baseline, 2 weeks, 12 weeks, 24 weeks, 1 year, 2 years, and 3 years post-surgery
Secondary outcome [4] 421881 0
Change in addictive eating behaviours assessed by the modified Yale Food Addication Scale (mYFAS 2.0)
Timepoint [4] 421881 0
Baseline, 2 weeks, 12 weeks, 24 weeks, 1 year, 2 years, and 3 years post-surgery
Secondary outcome [5] 422527 0
Weight-Loss (kg) as assessed by patient self-reported weight and linkage with the Bariatric Surgery Registry
Timepoint [5] 422527 0
Baseline, 2 weeks, 12 weeks, 24 weeks, 1 year, 2 years, and 3 years post-surgery
Secondary outcome [6] 422528 0
Surgical Adverse Events and/or complications as assessed by linkage with the Bariatric Surgery Registry.
(May include; unplanned return to theatre, unplanned admission to ICU, unplanned re-admission to hospital and any revision procedures)
Timepoint [6] 422528 0
Baseline, 2 weeks, 12 weeks, 24 weeks, 1 year, 2 years, and 3 years post-surgery

Eligibility
Key inclusion criteria
Adult, at least 18 years old
Obesity, BMI greater than or equal to 35 kg/m2
Undergoing primary bariatric surgery (intervention) or laparoscopic hiatus hernia repair (control)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous history of bariatric procedure(s)
Inability to complete online questionnaires

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The Bariatric Surgery Registry captures approximately 18,000 patients undergoing primary bariatric procedures in Australia each year. Given the longitudinal nature of the study and accounting for participant drop-out over time, a sample size of 1000 primary bariatric patients and 500 control patients was considered appropriate.

Follow-up data at each time point will be compared to assess change over time for each participant. Data will also be compared across demographic groups as well as by surgery type and surgical outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/03/2023
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
1500
Accrual to date
73
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313733 0
Government body
Name [1] 313733 0
National Health and Medical Research Council
Country [1] 313733 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash Universtiy,
Wellington Rd
Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 315874 0
None
Name [1] 315874 0
Address [1] 315874 0
Country [1] 315874 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312905 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 312905 0
Ethics committee country [1] 312905 0
Australia
Date submitted for ethics approval [1] 312905 0
05/01/2022
Approval date [1] 312905 0
28/02/2022
Ethics approval number [1] 312905 0
17/22

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

Contacts
Principal investigator
Name 126286 0
Prof Wendy Brown
Address 126286 0
Level 6, The Alfred Centre,
99 Commerical Rd, Melbourne, VIC, 3004
Country 126286 0
Australia
Phone 126286 0
+61 3 9903 0625
Fax 126286 0
Email 126286 0
[email protected]
Contact person for public queries
Name 126287 0
Alyssa Budin
Address 126287 0
Level 6, The Alfred Centre,
99 Commerical Rd, Melbourne, VIC, 3004
Country 126287 0
Australia
Phone 126287 0
+61 3 9903 0562
Fax 126287 0
Email 126287 0
[email protected]
Contact person for scientific queries
Name 126288 0
Alyssa Budin
Address 126288 0
Level 6, The Alfred Centre,
99 Commerical Rd, Melbourne, VIC, 3004
Country 126288 0
Australia
Phone 126288 0
+61 3 9903 0562
Fax 126288 0
Email 126288 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
Due to the sensitive nature of the data collected, and the potential for re-identification, IPD will not be publicly available.


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
No additional documents have been identified.