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Trial registered on ANZCTR


Registration number
ACTRN12618001697279
Ethics application status
Approved
Date submitted
1/10/2018
Date registered
15/10/2018
Date last updated
9/02/2023
Date data sharing statement initially provided
10/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the reciprocal effects of stress-related eating on sleeve gastrectomy: a randomised controlled study in people seeking treatment for obesity
Scientific title
Examining the reciprocal effects of stress-related eating on sleeve gastrectomy: a randomised controlled study in people seeking treatment for obesity
Secondary ID [1] 296215 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 309852 0
Condition category
Condition code
Metabolic and Endocrine 308643 308643 0 0
Other metabolic disorders
Diet and Nutrition 308692 308692 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adults with obesity who are awaiting sleeve gastrectomy (SG) will be invited to participate. Intervention: Sleeve gastrectomy (SG)
Participants will complete six validated questionnaires to assess non-homeostatic eating behaviours (such as stress-related eating, pleasure of eating), emotions and feelings. They will also have their weight recorded, and undergo a mixed meal test with a blood sample to assess appetite-regulating hormones at fasting and at 30, 60 and 120 mins post-prandially at baseline (pre-weight loss), and again 2 and 12 months post-intervention.

Data collection will be performed by a qualified study doctor or research nurse, face-to-face*, individually. Sleeve gastrectomy, a type of surgery for weight loss that involves removal of around 85% of the stomach, will be performed by a qualified bariatric surgeon (expected operating time 1-2 hours). All study visits and procedures will be performed at Austin Health or St Vincent’s Hospital Melbourne

*Addendum due to government and public health advice around social distancing and travel restrictions (as of 01 October 2021)
To remain in line with local hospital and government public health guidance around social distancing and travel restrictions, visits for newly recruited participants may be conducted remotely. Questionnaires to assess non-homeostatic eating behaviours will be conducted via telephone or video conference.

Participants who enter the study during the period of remote visits (i.e. remote visit 2) will not undergo a mixed meal test with blood samples and subjective appetite ratings.

Participants already enrolled as of 01/10/2021 will be asked to complete their remaining study visits in-person (as described above), and a remote visit conducted only if they are unable or unwilling to do so.
Intervention code [1] 312546 0
Treatment: Surgery
Comparator / control treatment
Half of the participants will be randomly allocated to using a very low energy diet (Optifast VLCD), containing approximately 800 kcal per day, for two months pre-operatively to serve as a comparison group. The diet will be instructed by a qualified dietitian or member of the study staff, face-to-face*, individually.

*Addendum due to government and public health advice around social distancing and travel restrictions (as of 01 October 2021)
To remain in line with local hospital and government public health guidance during the public health advice around social distancing and minimising travel, participants who enter the study during the period of remote visits will be instructed individually by a qualified dietitian or member of the study staff remotely, via telephone or video conference.
Control group
Active

Outcomes
Primary outcome [1] 307604 0
Change in Emotional Eating Scale score from baseline to 3 months compared between SG and diet (control) groups. .
Timepoint [1] 307604 0
3 months post-intervention (diet or surgery)
Secondary outcome [1] 352395 0
Weight change post-SG, measured using scales.
Timepoint [1] 352395 0
3 months and 12 months post-operatively.
Secondary outcome [2] 352396 0
Circulating (blood) GLP-1
Timepoint [2] 352396 0
3 months and 12 months post-operatively.
Secondary outcome [3] 352879 0
Circulating (blood) ghrelin
Timepoint [3] 352879 0
3 months and 12 months post-operatively.
Secondary outcome [4] 352880 0
Circulating (blood) PYY
Timepoint [4] 352880 0
3 months and 12 months post-operatively.
Secondary outcome [5] 352881 0
Circulating (blood) cortisol
Timepoint [5] 352881 0
baseline, 2 months and 12 months post-operatively
Secondary outcome [6] 372434 0
circulating (blood) orexin.
Timepoint [6] 372434 0
baseline, 3 months and 12 months post-operatively

Eligibility
Key inclusion criteria
Adults with obesity who are awaiting sleeve gastrectomy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Treatment for diabetes other than metformin
Contraindication for bariatric surgery or very-low-energy diet
Current use of appetite-reducing pharmacotherapy
Previous bariatric surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involves contacting the holder of the allocation schedule which is kept in a secure location
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated randomisation sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on estimated changes in EES score from pre- to post-intervention, 28 participants per arm would yield 80% power to observe a difference of 6 points in the pre- to 2-month post-intervention change between control and intervention groups. The total sample size for this study is therefore set as 60 patients (30 per arm) to account for loss to follow up at 2 months. The primary outcome measure, change in EES score from baseline to 2 months, will be compared between groups using an analysis of covariance (ANCOVA) model.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/07/2019
Actual
25/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
36
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21684 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 21685 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [3] 21686 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 36730 0
3065 - Fitzroy
Recruitment postcode(s) [2] 36731 0
3081 - Heidelberg West
Recruitment postcode(s) [3] 36732 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 300813 0
Hospital
Name [1] 300813 0
Austin Health
Country [1] 300813 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Austin Health
300 Waterdale Rd
Heidelberg Heights VIC 3081
Country
Australia
Secondary sponsor category [1] 300358 0
None
Name [1] 300358 0
Address [1] 300358 0
Country [1] 300358 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301582 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 301582 0
Austin Hospital
145 Studley Road
PO Box 5555 Heidelberg
Victoria 3084
Ethics committee country [1] 301582 0
Australia
Date submitted for ethics approval [1] 301582 0
Approval date [1] 301582 0
18/09/2018
Ethics approval number [1] 301582 0

Summary
Brief summary
The overall aim of this proposal is to explore the link between stress-related eating behavior and treatment outcomes in people undergoing treatment for obesity.
Patients who have been referred for surgical treatment for obesity (sleeve gastrectomy) will be invited to participate in a study in which half of them will be randomly allocated to using a very-low-energy diet (VLED) for 2 months while waiting for surgery. Participants will complete questionnaires, and have a meal test (involving collection of blood samples prior to and for 2 hours after a liquid meal) at the beginning of the study, and three months after the intervention (VLED or surgery), and 12 months after surgery. We hypothesise that stress-related eating will improve after sleeve gastrectomy, and will be associated with one or more hormones involved in appetite regulation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87462 0
Dr Priya Sumithran
Address 87462 0
The University of Melbourne
Clinical Sciences Building
St Vincent’s Hospital
Level 4, 29 Regent Street
Fitzroy VIC 3065
Country 87462 0
Australia
Phone 87462 0
+61 3 9231 2592
Fax 87462 0
Email 87462 0
[email protected]
Contact person for public queries
Name 87463 0
Priya Sumithran
Address 87463 0
The University of Melbourne
Clinical Sciences Building
St Vincent’s Hospital
Level 4, 29 Regent Street
Fitzroy VIC 3065
Country 87463 0
Australia
Phone 87463 0
+61 3 9231 2592
Fax 87463 0
Email 87463 0
[email protected]
Contact person for scientific queries
Name 87464 0
Priya Sumithran
Address 87464 0
The University of Melbourne
Clinical Sciences Building
St Vincent’s Hospital
Level 4, 29 Regent Street
Fitzroy VIC 3065
Country 87464 0
Australia
Phone 87464 0
+61 3 9231 2592
Fax 87464 0
Email 87464 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
At the time of registration, there were no requirements to make IPD from this study available


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2750Study protocol    protocol will be submitted with any publications a... [More Details]



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