Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000716965
Ethics application status
Approved
Date submitted
6/07/2011
Date registered
11/07/2011
Date last updated
11/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Personality as a predictor of diet induced weight loss and weight management
Scientific title
An investigation on whether measures of personality traits of obese individuals (BMI 30-40 Kg/m2) can be matched for compatibility with a particular dietary intervention to maximise weight loss
Secondary ID [1] 262577 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 268240 0
Condition category
Condition code
Diet and Nutrition 268371 268371 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants receive 4 x 1hr of nutrition education and counselling. In groups of 2-4 participants learn about the energy density of foods, the sizes of portions/serves, and how to use food labels on processed foods, Individually participants learn about their energy and nutrient needs, how to manage serve sizes from the different food groups and managing food choices when eating out. Participants follow either one of two dietary interventions for weight loss, either a low energy diet for gradual weight loss over a longer time frame, or a very low energy diet for rapid weight loss over a shorter time frame

1) The first 30 people accepted to take part in the study are allocated to follow a portion controlled reduced energy diet of 5,000-6,000 kJ/d for 12 weeks. Their diet is developed under the guidance of a dietitian and based on the Australian Guide to Healthy Eating. For the first four weeks participants attend weekly to monitor weight change and well being, and to discuss dietary issues. Thereafter, these participants attend fortnightly for monitoring to the end of their weight loss period of 12 weeks. This concludes their participation in the trial.

2) The second group of 30 people accepted to take part in the study are allocated to follow a very low energy diet of 3,000 kJ/d for 4 weeks using commercial meal replacements. These participants attend weekly to monitor weight change and well being, to discuss dietary issues and to receive a week's supply of meal replacements. For the first two weeks these participants consume meal replacements as prescribed by the suppliers of the meal replacements. For the next two weeks, these participants gradually phase out meal replacements and phase in meals while maintaining an energy intake of 3000 kJ/d. This group of participants then completes 8-10 weeks of weight maintenance to monitor weight stabilisation after rapid weight loss. This concludes their participantion in the trial.
Intervention code [1] 266909 0
Behaviour
Comparator / control treatment
The low energy diet group could be considered the control group and participants will only be entered into the very low energy diet group once the low energy diet is full
Control group
Active

Outcomes
Primary outcome [1] 269141 0
Comparison of % change in weight from baseline between the two groups using a calibrated balance beam scale to measure weight. An individual weight reduction of -5% is the desirable target
Timepoint [1] 269141 0
Baseline and at 12 weeks for the low energy diet.
Baseline and at 4 weeks for the very low energy diet.
Primary outcome [2] 269142 0
Examine possible correlations of personality traits with weight reduction of -5% (or more) and dietary weight loss strategy. The Five Factor Model of personality (McCrae & Costa, 1987), is used to measure three of the personality facets, Neuroticism, Conscientiousness and Extraversion. The Tangney Self Control Scale (Tangnery, Baumeister & Boone, 2004) is used to measure the personality facet, Self Control.
Timepoint [2] 269142 0
The personality questionnaires are completed by all participants at baseline.

Correlations of personality and weight loss are computed at 12 weeks for the low energy diet and at 4 weeks for the very low energy diet.
Secondary outcome [1] 279017 0
Comparison of % change in fat mass from baseline between the two groups using biolectrical impedance assessment.
Timepoint [1] 279017 0
Baseline and at 12 weeks for the low energy diet.
Baseline and at 4 weeks for the very low energy diet.

Eligibility
Key inclusion criteria
Body mass index (BMI) between 30 and 40
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI <30 or >40; diabetic

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants recruited from the general public through the media. Participants are weighed and complete a short health questionnaire to ensure that inclusion criteria are met.

Initially all participants applying commence the low energy diet for 12 weeks. Subsequently, when target sample size for the low energy diet is met, all of the participants applying commence the very low energy diet for 4 weeks until target sample size is met.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267383 0
Self funded/Unfunded
Name [1] 267383 0
Professor Manohar Garg
Country [1] 267383 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Nestle Nutrition, Australia
Address
1 Homebush Bay Drive
Rhodes NSW 2138
Country
Australia
Secondary sponsor category [1] 266444 0
None
Name [1] 266444 0
Address [1] 266444 0
Country [1] 266444 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269361 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 269361 0
Ethics committee country [1] 269361 0
Australia
Date submitted for ethics approval [1] 269361 0
Approval date [1] 269361 0
16/05/2007
Ethics approval number [1] 269361 0
H-159-1205

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32837 0
Address 32837 0
Country 32837 0
Phone 32837 0
Fax 32837 0
Email 32837 0
Contact person for public queries
Name 16084 0
Irene Munro
Address 16084 0
School of Biomedical Sciences and Pharmacy.
The University of Newcastle
University Drive
Callaghan NSW 2308
Country 16084 0
Australia
Phone 16084 0
+61 2 4921 5638
Fax 16084 0
+61 2 4921 2028
Email 16084 0
[email protected]
Contact person for scientific queries
Name 7012 0
Professor Manohar Garg
Address 7012 0
School of Biomedical Sciences and Pharmacy
The University of Newcastle
University Drive
Callaghan NSW 2308
Country 7012 0
Australia
Phone 7012 0
+61 2 4921 5647
Fax 7012 0
+61 2 4921 2028
Email 7012 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
SourceTitleYear of PublicationDOI
EmbaseUsing personality as a predictor of diet induced weight loss and weight management.2011https://dx.doi.org/10.1186/1479-5868-8-129
N.B. These documents automatically identified may not have been verified by the study sponsor.