Trial from ANZCTR


Trial ID ACTRN12611000716965
Trial Status: Registered
Date Submitted: 6/07/2011
Date Registered: 11/07/2011
Retrospectively registered

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Public title Personality as a predictor of diet induced weight loss and weight management
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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
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Secondary ID [1] 262577 0
Nil
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Obesity 268240 0
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Condition category: Condition code:
Diet and nutrition Obesity
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Descriptions 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.
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Intervention Code:
Behaviour 266909 0
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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
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Control group Active
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Primary Outcome: 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 269141 0
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Timepoint: Baseline and at 12 weeks for the low energy diet.
Baseline and at 4 weeks for the very low energy diet.
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Primary Outcome: 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. 269142 0
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Timepoint: 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.
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Secondary Outcome: Comparison of % change in fat mass from baseline between the two groups using biolectrical impedance assessment. 279017 0
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Timepoint: Baseline and at 12 weeks for the low energy diet.
Baseline and at 4 weeks for the very low energy diet.
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Key inclusion criteria Body mass index (BMI) between 30 and 40
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Minimum age 18 Years
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Maximum age 60 Years
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria BMI <30 or >40; diabetic
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Nonrandomised trial
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Describe the 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.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 1/02/2009
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 60
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Recruitment status Completed
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Self funded/Unfunded 267383 0
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Name: Professor Manohar Garg 267383 0
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Address: School of Biomedical Sciences and Pharmacy
The University of Newcastle
University Drive
Callaghan NSW 2308
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Country: Australia 267383 0
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Primary Sponsor Commercial sector/Industry
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Name: Nestle Nutrition, Australia
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Address: 1 Homebush Bay Drive
Rhodes NSW 2138
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Country: Australia
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Secondary Sponsor: None 266444 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: University of Newcastle Human Research Ethics Committee 269361 0
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Address: The University of Newcastle
University Drive
Callaghan NSW 2308
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Country: Australia 269361 0
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Approval Date: 16/05/2007 269361 0
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Submitted Date: 269361 0
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HREC: H-159-1205 269361 0
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Brief summary Weight loss can be difficult to achieve and maintain and long term dietary adherence rates are low. A major challenge for successful weight management is tailoring programs to meet individual needs, that is matching personal attributes and behaviours to a particular dietary weight loss strategy. This study investigates the matching of personality traits to compatible dietary weight loss programs for optimal weight loss
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Irene Munro
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Address: School of Biomedical Sciences and Pharmacy. The University of Newcastle University Drive Callaghan NSW 2308
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Country: Australia
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Tel: +61 2 4921 5638
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Fax: +61 2 4921 2028
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Email: Irene.Munro@uon.edu.au
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Contact person for scientific queries
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Name: Professor Manohar Garg
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Address: School of Biomedical Sciences and Pharmacy The University of Newcastle University Drive Callaghan NSW 2308
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Country: Australia
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Tel: +61 2 4921 5647
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Email: Manohar.Garg@newcastle.edu.au
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Contact person responsible for updating information
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Name: Irene Munro
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Address: School of Biomedical Sciences and Pharmacy The University of Newcastle University Drive Callaghan NSW 2308
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Country: Australia
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Tel: +61 2 4921 5638
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Fax: + 61 2 4921 2028
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Email: Irene.Munro@uon.edu.au
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Addition Cancer fields
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