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Trial registered on ANZCTR


Registration number
ACTRN12622000784718
Ethics application status
Approved
Date submitted
24/05/2022
Date registered
2/06/2022
Date last updated
16/11/2023
Date data sharing statement initially provided
2/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Understanding real-world health, wellbeing and dietary outcomes after metabolic and obesity surgery
Scientific title
Understanding real-world health, wellbeing and dietary outcomes after metabolic and obesity surgery
Secondary ID [1] 307206 0
nil
Universal Trial Number (UTN)
NA
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
metabolic and obesity surgery 326431 0
Obesity 326432 0
weight stigma 326435 0
mental health 326436 0
Condition category
Condition code
Diet and Nutrition 323714 323714 0 0
Obesity
Mental Health 323715 323715 0 0
Anxiety
Metabolic and Endocrine 323716 323716 0 0
Metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
People undergoing metabolic and obesity surgery will be observed for 2 years following surgery and asked to complete a series of validated questionnaires prior to surgery and at 3,6,12 and 24 months following surgery. They will undergo care as usual. Questionnaires will be emailed to participants via a secure REDCap database. Outcomes to be reported on and evaluated include: demographics, anthropometry (weight change and BMI), medical conditions, mental health status using the DASS questionnaire and medical assessment, quality of life (QoL) using the AQoL-8D questionnaire, dietary intake using a dietitians assessment tool and disorder eating behaviour using the EDE-q tool, physical activity using the international Physical Activity Questionnaire (IPAQ), weight stigma using the Weight Bias Internalization Scale (WBIS), reflux using the GastroEsphogeal Reflux Disease (GERD) questionnaire, use of social networks, patient beliefs and attendance at clinical appointments will be recorded as part of usual care.
Intervention code [1] 323652 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331461 0
The primary outcome measure is weight and weight change across time-points.
Assessment of this outcome will be weight in kilograms to the nearest one decimal place using digital scales. Weight change will also be recorded as percentage weight loss (%WL) and change in BMI (kg/m2). A stadiometer will be used to assess height in metres to 2 decimal places.
Timepoint [1] 331461 0
Timepoints for data collection will be at baseline, pre-surgery, then at 3 months, 6 months, 12 months and 24 months post surgery.
Secondary outcome [1] 409985 0
Quality of life will be measured by the AQoL-8D
Timepoint [1] 409985 0
The AQoL-8D will be sent to participants pre-surgery and then sent at 6 months, 12 months and 24 months post surgery.
Secondary outcome [2] 409986 0
Mental health changes from pre to post surgery will be assessed by measuring changes in the DASS (Depression, Anxiety, Stress Scales) questionnaire.
Timepoint [2] 409986 0
The DASS will be sent to participants to complete prior to surgery and then sent at 6 months, 12 months and 24 months post surgery.
Secondary outcome [3] 410101 0
Change in demographics and patient characteristics including education, employment, marital status, living situation, postcode, support networks and family life. These changes will be documented on a participant initial and follow-up questionnaire which was developed for this project by the research team who are familiar with bariatric cohorts.
Timepoint [3] 410101 0
The participant initial questionnaire will be sent prior to surgery and the follow-up questionnaire sent at 3 months, 6 months, 12 months and 24 months post surgery.
Secondary outcome [4] 410102 0
Changes in metabolic risk profile including changes in
• HbA1c*
• Fasting glucose (mmol/L) and insulin (mlU/L)
• Fasting lipid profile (total cholesterol, HDLc, LDLc, triglycerides)
• liver enzymes
• hsCRP
Using data collected from standard usual care pathology results, and
• Blood pressure will be measured using an Oscillometric Sphygmomanometer
The BP measure will be recorded into the database using data from a doctor's assessment form.
Timepoint [4] 410102 0
The metabolic profile data will be collected by the researcher from the surgeon's clinical notes and pathology reports pre-surgery and then at 3 months, 6 months, 12 months and 24 months post surgery.
Secondary outcome [5] 410103 0
Change in use and need for medications. This will be documented in the database from information provided from the surgeon's clinical notes.
Timepoint [5] 410103 0
The medication change will be collected from the surgeon's clinical notes at pre-surgery and then at 3 months, 6 months, 12 months and 24 months post surgery.
Secondary outcome [6] 410104 0
Change in medical conditions from pre to post surgery. This will be documented in the research database based on from information provided from the surgeon's clinical notes. This may include change in diabetes status, sleep disorders, gastrointestinal symptoms, pain status and cardiovascular health.
Timepoint [6] 410104 0
The medical condition changes will be collected from the surgeon's clinical notes at pre-surgery and then at 3 months, 6 months, 12 months and 24 months post surgery.
Secondary outcome [7] 410105 0
Nutritional deficiencies and dietary quality will be assessed by conducting:
i) a dietitian assessment via a purpose built dietary survey tool,
ii) participants completing the Eating Disorder Examination questionnaire (EDE-q)
iii) usual care pathology including blood measures of vitamins D and c, Iron studies, Vitamin B1, B12 and serum folate, zinc, copper and selenium. Urine measure include 24-hour collection for creatinine, Na, K, Ca(paired with serum EUC/CMP)
Timepoint [7] 410105 0
The dietary intake outcomes will be collected at 3 months, 6 months, 12 months and 24 months post surgery. No pre-surgery dietary intake data will be collected.
Dietary behaviour, using the EDE-q will be collected pre-surgery and then at 6,12 and 24 months post surgery.
Secondary outcome [8] 410106 0
Physical activity measures and changes will be ssessed by the IPAQ - International Physical Activity Questionnaire.
Timepoint [8] 410106 0
The IPAQ will be sent to participants to complete prior to surgery and then sent at 6 months, 12 months and 24 months post surgery.
Secondary outcome [9] 410107 0
Weight stigma will be measured by using the Weight Bias Internalization Scale (WBIS) questionnaire to be complete by participants.
Timepoint [9] 410107 0
The WBIS will be sent to participants to complete prior to surgery and then sent at 6 months, 12 months and 24 months post surge
Secondary outcome [10] 410108 0
Patient attendance at appointments, attrition, and reasons for attrition, collected from administration records at clinics and recorded on the database in the appointments record form.
Timepoint [10] 410108 0
Appointments will be collected from the surgeon's office annually- at 12 months and 24 months post surgery.
Secondary outcome [11] 410320 0
Mental health will be assessed by the surgeon and recorded in the medical assessment form. Details of mental health will include use of addictive substance usage including alcohol, smoking, drugs, and addictive behaviours including gambling, sex addiction and gaming.
Timepoint [11] 410320 0
Mental health assessments will be made at presurgery and then at 3, 6 12 and 24 months post surgery

Eligibility
Key inclusion criteria
To be included in this research, participants must meet these requirements:
• Planning bariatric surgery
• older than 16 years
• able to understand the study protocol and/or give written consent to participate
• agreeable to participate in all usual clinical data collection and to complete additional questionnaires, surveys and recording of usual food intake supplementary to normal clinical procedure
• willing to allow the use of a translator or family member to assist in completion of these assessments and surveys, questionnaires and usual food intake records, if English is the second language, or if they have poor literacy levels.
Minimum age
16 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Younger than 16 years
inability to understand and give consent

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be analysed using SPSS v25 after developing a detailed Statistical Analysis Plan. Descriptive statistics will be used to outline the baseline characteristics and linear and generalised linear mixed models and survival models will be used for the longitudinal data analysis. This model uses all available data therefore participants with missing data or who are lost to follow-up are still included in the analysis. Relevant covariates will be included.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/04/2022
Date of last participant enrolment
Anticipated
30/12/2023
Actual
Date of last data collection
Anticipated
10/01/2026
Actual
Sample size
Target
250
Accrual to date
225
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22430 0
Norwest Private Hospital - Bella Vista
Recruitment hospital [2] 22431 0
Nepean Private Hospital - Kingswood
Recruitment hospital [3] 23357 0
Calvary Private Hospital - Wagga Wagga
Recruitment hospital [4] 23358 0
Nepean Hospital - Kingswood
Recruitment hospital [5] 23359 0
Wagga Wagga Base Hospital - Wagga Wagga
Recruitment postcode(s) [1] 37626 0
2153 - Bella Vista
Recruitment postcode(s) [2] 37629 0
2153 - Baulkham Hills
Recruitment postcode(s) [3] 38735 0
2650 - Wagga Wagga
Recruitment postcode(s) [4] 38736 0
2747 - Kingswood
Recruitment postcode(s) [5] 38737 0
2650 - Wagga Wagga

Funding & Sponsors
Funding source category [1] 311505 0
University
Name [1] 311505 0
The University of Sydney
Country [1] 311505 0
Australia
Primary sponsor type
Individual
Name
Dr Kathryn Williams
Address
Nepean Family Metabolic Health Service
Nepean hospital,
Derby Street
Kingswood, NSW 2747
Country
Australia
Secondary sponsor category [1] 312993 0
None
Name [1] 312993 0
Address [1] 312993 0
Country [1] 312993 0
Other collaborator category [1] 282321 0
Individual
Name [1] 282321 0
Dr Michael Devadas
Address [1] 282321 0
Norwest Private Hospital:
Suite C202 C Block
9 Norbrik Drive Bella Vista
PO BOX 6551 Baulkham Hills,
NSW, 1755
Country [1] 282321 0
Australia
Other collaborator category [2] 282322 0
Individual
Name [2] 282322 0
Sally Badorrek
Address [2] 282322 0
Nepean Family Metabolic Health Service
Nepean hospital,
Derby Street
Kingswood, NSW 2747
Country [2] 282322 0
Australia
Other collaborator category [3] 282449 0
Individual
Name [3] 282449 0
Rachel Russell
Address [3] 282449 0
c/o Metabolic Obesity Service
Health Services Hub, Wagga Wagga Base Hospital
260-280 Edward Street, PO Box 159
Wagga Wagga NSW 2650
Country [3] 282449 0
Australia
Other collaborator category [4] 282450 0
Individual
Name [4] 282450 0
Associate Professor Nicholas Williams
Address [4] 282450 0
Harrison Williams Consulting
18/2 Docker St
Wagga Wagga NSW 2650
Australia
Country [4] 282450 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310967 0
Nepean Blue Mountains Local Health District Ethics Committee HREC
Ethics committee address [1] 310967 0
Human Research Ethics Committee
Research Office
Level 5, South Block
Nepean Hospital
Kingswood NSW 2747
PO Box 63
Penrith NSW 2750
Ethics committee country [1] 310967 0
Australia
Date submitted for ethics approval [1] 310967 0
03/12/2020
Approval date [1] 310967 0
15/12/2020
Ethics approval number [1] 310967 0
2020/ETH02984

Summary
Brief summary
AIM
Metabolic and obesity surgery (MOS) is currently the most effective, durable strategy for weight management. Comprehensive outcome data following metabolic and obesity surgery is missing from the Australian bariatric population. This prospective long term cohort study aims to document and evaluate medical, psychosocial and behavioural factors linked to outcome measures.
METHODS
Recruitment will commence from April 2021 and continue until November 2023 or until 250 participants are recruited. The study will observe participants for 2 years with data collection commencing 1-2 months pre-MOS and at timepoints 3,6,12 and 24 months post-surgery. Participants include those undergoing surgery over 16 years of age, able to read and write English and give consent. All participants will receive usual care during the study period. Data collection will include demographics and family traits; medical history, mental health via the Depression, Anxiety and Stress Scale (DASS); Quality of Life via the Assessment of Quality of Life (AQoL-8D); dietary intake (via a dietitian assessment survey and a participant-completed food frequency questionnaire); dietary behaviour via the Eating Disorder Examination questionnaire (EDE-Q); social factors; weight stigma using the Weight Bias Stigmatisation Scale (WBIS); use of social support networks and beliefs using patient-completed surveys; and attendance at clinical appointments. The primary outcome of weight change will be reported in kilogram (kg) weight change, BMI (kg/m2) and percentage weight loss (%WL), secondary outcome measures will include health and psychosocial variables evaluated in the study.
STATISTICAL ANALYSIS
Descriptive statistics will be used to profile the baseline characteristics of the participants. Linear and generalised linear mixed models and survival models will be used for the longitudinal data analysis.
The investigators plan to present and publish the findings of this study at scientific meetings, both nationally and internationally and in peer reviewed journals. Participants will be unidentifiable with results being anonymised.
SUMMARY
Obesity effects a third of Australians and MOS in Australia has become a popular tool for obesity management. This surgery is mainly performed in the private setting with minimal data available reporting on outcomes including that of health, psychosocial wellbeing, and dietary changes. This prospective observational study will add to the limited literature from the Australian setting, important real-world data on the long-term comprehensive outcomes following MOS. Results may assist clinicians in providing best practice individualised care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119526 0
Dr Kathryn Williams
Address 119526 0
Nepean Family Metabolic Health Service
Nepean Hospital
Derby Street
Level 5, South Block
Kingswood, NSW 2747
Country 119526 0
Australia
Phone 119526 0
+61 2 4734 3594
Fax 119526 0
+61 2 47341920
Email 119526 0
[email protected]
Contact person for public queries
Name 119527 0
Sally Badorrek
Address 119527 0
Nepean Family Metabolic Health Service
Nepean Hospital
Derby Street
Level 5, South Block
Kingswood, NSW 2747
Country 119527 0
Australia
Phone 119527 0
+61 2 4734 3594
Fax 119527 0
+61 2 47341920
Email 119527 0
[email protected]
Contact person for scientific queries
Name 119528 0
Kathryn Williams
Address 119528 0
Nepean Family Metabolic Health Service
Nepean Hospital
Derby Street
Level 5, South Block
Kingswood, NSW 2747
Country 119528 0
Australia
Phone 119528 0
+61 2 4734 3594
Fax 119528 0
+61 2 47341920
Email 119528 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
No additional documents have been identified.