Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000655549
Ethics application status
Approved
Date submitted
26/05/2015
Date registered
25/06/2015
Date last updated
25/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of the Royal Melbourne Hospital Obesity Clinic in the treatment of obesity in the Victorian adult population.
Scientific title
Adults referred to the RMH Obesity clinic with a BMI over 30kg/m2, undergoing a 12 months lifestyle intervention program with an Endocrinologist and Dietician, comparing weight and metabolic profiles at 12months to baseline and previously published data for lifestyle intervention programs.
Secondary ID [1] 286801 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 295178 0
Condition category
Condition code
Diet and Nutrition 295425 295425 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with a BMI above 30kg/m2 who had attended the Royal Melbourne Hospital Obesity Clinic are observed for weight, quality of life and metabolic profile changes. Involving 1month, 3 month, 6 month and 12 month consultation with an endocrinologist and dietitian. Patients were excluded if they were referred to a different clinic at first visit or if they were determined unsuitable by wanting bariatric surgery prior to clinic attendance. Time period was January 2012 – June 2015.
Intervention code [1] 291961 0
Not applicable
Comparator / control treatment
Compared to Baseline Characteristics
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295158 0
Primary Outcome 1: Weight loss. Assessed by clinical scales and then obtained from the Royal Melbourne Hospital Obesity Databse.

Timepoint [1] 295158 0
Baseline is initial Clinic visit until 12 months post first visit. If patients did not reach 12 months then the closest follow up to the 12 months was considered. If patients exceeded 12 months then all attendances were used for comparison. Patients were assessed for weight loss at all clinic visits, during 12 month period patients were assessed at approximately 6weeks, 3 months, 6 months and 12 months.
Secondary outcome [1] 314897 0
Secondary Outcome 1: Change in Lipid Profiles including Total Cholesterol, Triglycerides, LDL and HDL levels.
Timepoint [1] 314897 0
Pathology taken within 3 months of initial consultation, again within 3 months of the 12 month follow up consultation.
Secondary outcome [2] 315281 0
Change in HbA1c reading
Timepoint [2] 315281 0
Pathology taken within 3 months of initial consultation, again within 3 months of the 12 month follow up consultation.
Secondary outcome [3] 315282 0
Change in Liver Function Tests, including AST, ALP, GGT and ALT
Timepoint [3] 315282 0
Pathology taken within 3 months of initial consultation, again within 3 months of the 12 month follow up consultation.
Secondary outcome [4] 315283 0
Change in Thyroid Stimulating Hormone
Timepoint [4] 315283 0
Pathology taken within 3 months of initial consultation, again within 3 months of the 12 month follow up consultation.
Secondary outcome [5] 315284 0
Change in Fasting Glucose
Timepoint [5] 315284 0
Pathology taken within 3 months of initial consultation, again within 3 months of the 12 month follow up consultation.
Secondary outcome [6] 315285 0
Change in Serum C-Peptide levels
Timepoint [6] 315285 0
Pathology taken within 3 months of initial consultation, again within 3 months of the 12 month follow up consultation.
Secondary outcome [7] 315286 0
Change in Serum Testosterone levels
Timepoint [7] 315286 0
Pathology taken within 3 months of initial consultation, again within 3 months of the 12 month follow up consultation.
Secondary outcome [8] 315287 0
Change in Serum Insulin Levels
Timepoint [8] 315287 0
Pathology taken within 3 months of initial consultation, again within 3 months of the 12 month follow up consultation.
Secondary outcome [9] 315288 0
Change in Quality of Life Survey Scores
Timepoint [9] 315288 0
Surveys were completed before initial consultation and again after the 12 months follow-up consultation.

Eligibility
Key inclusion criteria
Patients with a BMI above 30kg/m2 who have attended the Royal Melbourne Hospital Obesity Clinic. Between the period of 2012 – 2015.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded if they were referred away from the clinic on their first and only visit, or if they were determined not to benefit from clinic due to desiring bariatric surgery before given an initial consultation. They were excluded if under 18 years old or under a BMI of 30kg/m2.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Weight gain tertiles will be compared by non-parametric ANOVA
Baseline correlates of weight gain will be identified by multiple regression analysis. Number of participants was determined by inclusion of all eligible participants who attended the Bariatric Clinic from its commencement in 2012. No statistical analysis was used to determine whether this sample size would achieve study objectives.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2015
Actual
2/02/2015
Date of last participant enrolment
Anticipated
29/05/2015
Actual
12/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3833 0
Royal Melbourne Hospital - City campus - Parkville

Funding & Sponsors
Funding source category [1] 291342 0
Hospital
Name [1] 291342 0
Royal Melbourne Hospital
Country [1] 291342 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
300 Grattan Street, Parkville VIC 3050
Country
Australia
Secondary sponsor category [1] 290021 0
None
Name [1] 290021 0
Address [1] 290021 0
Country [1] 290021 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292905 0
Melbourne Health Office for Research
Ethics committee address [1] 292905 0
6 East, Main Building, Royal Melbourne Hospital, 300 Grattan Street Parkville VIC 3050
Ethics committee country [1] 292905 0
Australia
Date submitted for ethics approval [1] 292905 0
15/09/2014
Approval date [1] 292905 0
19/09/2014
Ethics approval number [1] 292905 0
QA2014163

Summary
Brief summary
This project aims to determine: 1. Weight loss profiles for patients attend the Royal Melbourne Hospital Obesity clinic. 2. The impact of this weight loss of metabolic parameters such as lipid profile and liver function tests. 3. To determine the impact of this weight loss on Quality of Life Survey results 4. To find factors that predict the occurrence of weight loss in people with obesity who attended the Obesity Clinic.
Hypothesis: Weight loss will be comparable to published data on lifestyle interventions at an average of 5% body weight loss. This weight loss will be variable depending on baseline characteristics such as family history, concurrent mental health issues and low starting motivation being negative predictors for weight loss. Patients who lose weight will show improvement in the metabolic profiles and Quality of Life survey results when compared to those who do not lose weight.
Trial website
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 57590 0
Miss Lauren Cussen
Address 57590 0
Royal Melbourne Hospital, 300 Grattan Street Parkville, VIC 3050
Country 57590 0
Australia
Phone 57590 0
+61417246024
Fax 57590 0
Email 57590 0
[email protected]
Contact person for public queries
Name 57591 0
Miss Lauren Cussen
Address 57591 0
Royal Melbourne Hospital, 300 Grattan Street Parkville, VIC 3050
Country 57591 0
Australia
Phone 57591 0
+61417246024
Fax 57591 0
Email 57591 0
[email protected]
Contact person for scientific queries
Name 57592 0
Miss Lauren Cussen
Address 57592 0
Royal Melbourne Hospital, 300 Grattan Street Parkville, VIC 3050
Country 57592 0
Australia
Phone 57592 0
+61417246024
Fax 57592 0
Email 57592 0
[email protected]

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
No additional documents have been identified.