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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12611000285954 |
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Date of registration:
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18/03/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Do psychological variables predict weight loss in obese individuals after bariatric surgery?
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Scientific title:
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Do psychological variables predict weight loss after Laparoscopic Adjustable Gastric Banding (LAGB) Surgery? |
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Date of first enrolment:
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07/10/2009 |
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Target sample size:
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200 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://anzctr.org.au/ACTRN12611000285954.aspx |
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Study type:
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Observational |
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Study design:
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Purpose: Psychosocial;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Melissa Hayden
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Address:
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Centre for Obesity Research and Education (CORE)
School of Public Health & Preventive Medicine
Monash University
The Alfred Hospital, Commercial Road
Melbourne Victoria 3004 Australia
Australia |
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Telephone:
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61 3 9903 0613 |
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Email:
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Melissa.Hayden@med.monash.edu.au |
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Affiliation:
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Name:
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Dr Melissa Hayden
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Address:
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Centre for Obesity Research and Education (CORE)
School of Public Health & Preventive Medicine
Monash University
The Alfred Hospital, Commercial Road
Melbourne Victoria 3004 Australia
Australia |
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Telephone:
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61399030613 |
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Email:
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melissa.hayden@monash.edu |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Entry into the study would require patients be:
1. Aged over 18 years
2. Proficient in English
3. Eligible for bariatric surgery
Exclusion criteria: 1. Aged under 18 yrs
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Mental Health - Depression
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Mental Health - Psychosis and personality disorders
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obesity;
obesity
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Surgery - Other surgery
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Intervention(s)
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The intervention is a take home questionnaire pack which will take ~1 hour to complete,
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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.
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Primary Outcome(s)
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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.[Baseline, at 6 months, and at 12 and 24 months post surgery]
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Secondary Outcome(s)
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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.[Baseline, at 6 months, and at 12 and 24 months post surgery]
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Source(s) of Monetary Support
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Centre for Obesity Research & education
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Ethics review
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Status: Not approved
Approval date:
Contact:
Monash University Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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