Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000315617
Ethics application status
Approved
Date submitted
24/08/2005
Date registered
6/09/2005
Date last updated
6/12/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
An observational study of the effect of eating behaviours, dietary and exercise strategies on weight loss at 12 months.
Scientific title
An observational study of the effect of eating behaviours, dietary and exercise strategies on weight loss at 12 months in obese patients.
Secondary ID [1] 253240 0
Effect of eating behaviours, dietary and exercise strategies on weight loss
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 403 0
Condition category
Condition code
Diet and Nutrition 474 474 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Approximately 200 consecutive preoperative severely obese patients presenting for obesity surgery will complete a series of self-report questionnaires: A Food Frequency Questionnaire, General eating patterns questionnaire, the Baecke Activity Questionnaire, The Questionnaire on Eating and Weight Patterns, Night Eating Syndrome Questionnaire, Three Factor Eating Questionnaire, SF-36, MultiDimensional Body-Self Relations Questionnaire, Beck Depression Inventory . Dietary intake data will be collected at baseline, 4 months and 12 months after surgery. Baseline and 12 month average daily energy and nutrient intake will be determined as well as the habitual types and amounts of physical activity and exercise at baseline and 12 months after surgery. Questionnaire responses will also be compared with data collected from ~200 normal weight community controls and~ 200 obese controls.
Intervention code [1] 251 0
Treatment: Surgery
Comparator / control treatment
Questionnaire responses from the severely obese patients will be compared with data collected from ~200 normal weight community controls and~ 200 obese controls.
Control group
Active

Outcomes
Primary outcome [1] 542 0
Change in weight at 12 months
Timepoint [1] 542 0
At 12 months
Primary outcome [2] 543 0
Change in weight and its relationship to eating behaviours and exercise.
Timepoint [2] 543 0
At 12 months
Secondary outcome [1] 1145 0
Comparison of responses with normal weight and obese controls
Timepoint [1] 1145 0
At 12 months
Secondary outcome [2] 1146 0
Change in energy and macronutrient intakes
Timepoint [2] 1146 0
At 12 months
Secondary outcome [3] 1147 0
Change in physical activity patterns
Timepoint [3] 1147 0
At 12 months
Secondary outcome [4] 1148 0
Change in eating behaviours
Timepoint [4] 1148 0
At 12 months
Secondary outcome [5] 1149 0
Comparison of abnormal eating behaviours with control groups and
Timepoint [5] 1149 0
At 12 months after surgery.

Eligibility
Key inclusion criteria
Group 1- Preoperative severely obese will satisfy the criteria for inclusion into the Lap-Band program.Group 2- Normal weight community members who consent to completing the questionnaires.Group 3- Obese community members who consent to completing the questionnaires
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All groups: previous bariatric surgery, severe physical disability, inability to read or write fluently in English, inadequate cognitive skills to interpret the study questionnaires.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2004
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] 534 0
University
Name [1] 534 0
Centre for Obesity Research and Education (CORE) Monash University
Country [1] 534 0
Australia
Primary sponsor type
University
Name
Centre for Obesity Research and Education (CORE)
Address
Centre for Obesity Research and Education (CORE) Monash University Medical School Alfred Hospital Commercial Road Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 434 0
None
Name [1] 434 0
none
Address [1] 434 0
Country [1] 434 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Colles SL, Dixon JB, O'Brien PE. Grazing and Loss of Control Related to Eating: Two High-risk Factors Following Bariatric Surgery. Obesity (Silver Spring). Mar 2008;16(3):615-622.

Colles SL, Dixon JB, O'Brien PE. Loss of control is central to psychological disturbance associated with binge eating disorder. Obesity (Silver Spring). Mar 2008;16(3):608-614

Colles SL, Dixon JB, O'Brien P E. Night eating syndrome and nocturnal snacking: association with obesity, binge eating and psychological distress. Int J Obes (Lond). Jun 19 2007
Public notes

Contacts
Principal investigator
Name 36289 0
Address 36289 0
Country 36289 0
Phone 36289 0
Fax 36289 0
Email 36289 0
Contact person for public queries
Name 9440 0
Ms Susan Colles
Address 9440 0
Centre for Obesity Research and Education (CORE)
Monash University Medical School
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 9440 0
Australia
Phone 9440 0
+61 3 99030721
Fax 9440 0
+61 3 95103365
Email 9440 0
[email protected]
Contact person for scientific queries
Name 368 0
Associate Professor John Dixon
Address 368 0
Monash University
School of Primary Health Care
Building 1, 270 Ferntree Gully Road
Notting Hill 3168
Country 368 0
Australia
Phone 368 0
+61 3 9501 2431
Fax 368 0
+61 3 8575 2233
Email 368 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.