Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000307202
Ethics application status
Approved
Date submitted
17/04/2009
Date registered
19/05/2009
Date last updated
22/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Weight Loss in Overweight Women Study
Scientific title
Comparision of a red to white meat based diet on weight loss, body composition, metabolic and immune function in overweight young (18-25 year old) women
Secondary ID [1] 273437 0
Efficacy of a higher-protein compared to a higher-carbohydrate diet for weight management in young overweight and obese women: a 12 month randomized controlled trial
Universal Trial Number (UTN)
Trial acronym
WOW study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 4626 0
Obesity 4627 0
Condition category
Condition code
Diet and Nutrition 4926 4926 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prescription of either one of the two diets through randomisation. The two diets involve iso-energetic, low fat, low glycaemic index (GI) diets that differ in carbohydrate (glycaemic load) and protein content as well as red and white meat content.
This involves a daily diet change for a total of 12 months.

All subjects (regardless of which diet they are assigned) will be asked to complete a minimum of 30 minutes light exercise on most days of the week.
Intervention code [1] 4385 0
Behaviour
Intervention code [2] 4386 0
Lifestyle
Comparator / control treatment
A high carbohydrate (glycaemic load), moderate protein diet that is mostly based on white meat. Subjects will be asked to follow this diet daily for 12 months.

It differs from the intervention group in that the other diet involves a moderate carbohydrate (glycaemic load), high protein diet that is mostly based on red meat.
Control group
Active

Outcomes
Primary outcome [1] 5773 0
Weight loss through the use of scales
Timepoint [1] 5773 0
6 and 12 months after intervention
Primary outcome [2] 5774 0
Body fat loss through the use of:
1. Bioelectrical Impedance Analysis (BIA)
2. Dual-energy X-ray Absorptiometry (DEXA)
Timepoint [2] 5774 0
6 and 12 months after intervention
Secondary outcome [1] 241734 0
Improved immune function through the use of:
1. Blood test (e.g. testing of immune and inflammatory markers)
2. health log (log of subjective health throughout the 12 months of the trial)
3. Infection Visual Analogue scale (a subjective measurement of general health)
Timepoint [1] 241734 0
6 and 12 months after intervention

Eligibility
Key inclusion criteria
Young women Body Mass Index (BMI) >27.5 kg/m2
Minimum age
18 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smokers, iron deficiency, diabetes (I or II), severe eating disorders, depression or medication influencing metabolism

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random allocation (sealed opaque envelopes)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised table from statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The glycaemic load of the diets are different but this is not disclosed to the study participants but is known by the investigators
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4810 0
Commercial sector/Industry
Name [1] 4810 0
Meat and Livestock Australia
Country [1] 4810 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Discipline of Exercise and Sport Science
University of Sydney
PO BOX 170 Lidcombe 1825 Australia
Country
Australia
Secondary sponsor category [1] 4341 0
Hospital
Name [1] 4341 0
Royal Prince Alfred Hospital
Address [1] 4341 0
Metabolism and Obesity Services
Royal Prince Alfred Hospital
Level 6 E Block Missenden Rd Camperdown NSW 2050 Australia
Country [1] 4341 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6855 0
Central Sydney Human Ethics
Ethics committee address [1] 6855 0
Royal Prince Alfred Hospital
Sydney
Ethics committee country [1] 6855 0
Australia
Date submitted for ethics approval [1] 6855 0
Approval date [1] 6855 0
01/02/2005
Ethics approval number [1] 6855 0

Summary
Brief summary
Comparison of higher protein, moderate carbohydrate red meat based “Total Wellbeing” diet versus iso-energetic, conventional, low fat, high carbohydrate diet on weight loss, immune function, satiety, metabolic parameters and iron status in young, overweight and obese women.

Research Hypothesis: A higher protein, red meat based diet for weight management in overweight and obese young women will improve satiety, eating behaviours, markers of immune function and metabolic parameters when compared to an iso-energetic higher carbohydrate, white meat based diet.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29507 0
Address 29507 0
Country 29507 0
Phone 29507 0
Fax 29507 0
Email 29507 0
Contact person for public queries
Name 12754 0
Dr Helen O'Connor
Address 12754 0
Discipline of Exercise and Sport Science
University of Sydney
PO BOX 170 Lidcombe 1825
Country 12754 0
Australia
Phone 12754 0
+61 2 9351 9625
Fax 12754 0
+61 2 9351 9204
Email 12754 0
[email protected]
Contact person for scientific queries
Name 3682 0
Dr Helen O'Connor
Address 3682 0
Discipline of Exercise and Sport Science
University of Sydney
PO BOX 170 Lidcombe 1825
Country 3682 0
Australia
Phone 3682 0
+61 2 9351 9625
Fax 3682 0
+61 2 9351 9204
Email 3682 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.