Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000285954
Ethics application status
Approved
Date submitted
7/10/2009
Date registered
18/03/2011
Date last updated
13/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Do psychological variables predict weight loss in obese individuals after bariatric surgery?
Scientific title
Do psychological variables predict weight loss after Laparoscopic Adjustable Gastric Banding (LAGB) Surgery?
Secondary ID [1] 259798 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 251971 0
Condition category
Condition code
Surgery 252161 252161 0 0
Other surgery
Mental Health 252162 252162 0 0
Psychosis and personality disorders
Mental Health 265551 265551 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The intervention is a take home questionnaire pack which will take ~1 hour to complete,
and
a 1 session with interviewer which will last between 1- 2 hours

The aim of this psychological assessment study is to identify baseline psychological correlates which may help predict individuals who are more or less likely to achieve minimal weight loss goals after LAGB surgery. LAGB placement provides a safe and reliable method of achieving and sustaining significant weight loss in the majority of obese patients. It consists of placing an adjustable silicone gastric band just below the gastroesophageal junction. The band is adjustable by injection of saline into a peripherally placed reservoir.

A psychological assessment is part of standard protocol for Bariatric Surgery in the US, however, there is no data to date evaluating its effectiveness in the treatment of obesity. Therefore, the study aims to evaluate the use of interviews in bariatric surgery. In addition to the inclusion of bariatric and psychiatric interviews, psychological constructs measuring stress, social support, mood, coping, motivation and self-efficacy will also be investigated through the use of paper and pencil questionnaires.

Successful screening and identification of individuals who are unlikely to achieve minimal weight loss goals could potentially reduce patient distress and such individuals could be directed to more suitable weight loss approach. It is also important to understand factors which may inhibit or reduce weight loss in those individuals in order to maximise weight loss outcomes.
Intervention code [1] 241383 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253029 0
The initial aim of this study is to characterize by psychological interview, using the Structured Clinical Interview (SCID), the prevalence, nature and severity of AXIS I clinical disorders. In addition to the psychological interview a selection of psychological questionnaires will also be included to complement and expand upon findings from the interview. Specifically the psychological questionnaires include; mood disorders, eating behaviours and cognitive style.
Timepoint [1] 253029 0
Baseline, at 6 months, and at 12 and 24 months post surgery
Secondary outcome [1] 257849 0
The second aim of this study is to investigate possible predictors of good and poor weight loss outcomes and compliance 12 months and 24 months after surgery. Poor weight loss will be defined as losing less than 25% of excess weight following LAGB and good weight loss is the loss of more than 50% of excess weight at 24 months.
Timepoint [1] 257849 0
Baseline, at 6 months, and at 12 and 24 months post surgery

Eligibility
Key inclusion criteria
Entry into the study would require patients be:
1. Aged over 18 years
2. Proficient in English
3. Eligible for bariatric surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Aged under 18 yrs

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
7/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243844 0
Self funded/Unfunded
Name [1] 243844 0
Centre for Obesity Research & education
Country [1] 243844 0
Australia
Primary sponsor type
Other
Name
Centre for Obesity Research & education
Address
Centre for Obesity Research and Education (CORE)
School of Public Health & Preventive Medicine
Monash University
The Alfred Hospital, Commercial Road
Melbourne Victoria 3004 Australia
Country
Australia
Secondary sponsor category [1] 237194 0
None
Name [1] 237194 0
Address [1] 237194 0
Country [1] 237194 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243971 0
Monash University Ethics Committee
Ethics committee address [1] 243971 0
Ethics committee country [1] 243971 0
Australia
Date submitted for ethics approval [1] 243971 0
01/10/2006
Approval date [1] 243971 0
Ethics approval number [1] 243971 0
2006-810

Summary
Brief summary
The aim of this psychological assessment study is to identify baseline psychological correlates which may help predict individuals who are unlikely to achieve minimal weight loss goals. Successful screening and identification of individuals who are unlikely to achieve minimal weight loss goals could potentially reduce patient distress and such individuals could be directed to more suitable weight loss approach. It is also important to understand factors which may inhibit or reduce weight loss in those individuals in order to maximise weight loss outcomes. The aim is to investigate how specific traits affect weight loss outcomes and identify those areas which through the use of behaviour therapy, can be modified to improve weight loss outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30362 0
Address 30362 0
Country 30362 0
Phone 30362 0
Fax 30362 0
Email 30362 0
Contact person for public queries
Name 13609 0
Dr Melissa Hayden
Address 13609 0
Centre for Obesity Research and Education (CORE)
School of Public Health & Preventive Medicine
Monash University
The Alfred Hospital, Commercial Road
Melbourne Victoria 3004 Australia
Country 13609 0
Australia
Phone 13609 0
61399030613
Fax 13609 0
Email 13609 0
melissa.hayden@monash.edu
Contact person for scientific queries
Name 4537 0
Dr Melissa Hayden
Address 4537 0
Centre for Obesity Research and Education (CORE)
School of Public Health & Preventive Medicine
Monash University
The Alfred Hospital, Commercial Road
Melbourne Victoria 3004 Australia
Country 4537 0
Australia
Phone 4537 0
61 3 9903 0613
Fax 4537 0
Email 4537 0
Melissa.Hayden@med.monash.edu.au

No information has been provided regarding IPD availability


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
EmbasePre-operative Restraint and Post-operative Hunger, Disinhibition and Emotional Eating Predict Weight Loss at 2 Years Post-laparoscopic Adjustable Gastric Banding.2020https://dx.doi.org/10.1007/s11695-019-04274-9
N.B. These documents automatically identified may not have been verified by the study sponsor.