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Trial registered on ANZCTR
Registration number
ACTRN12605000537651
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
28/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered
Titles & IDs
Public title
Aspire
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Scientific title
Comparative weight loss in overweight people randomly assigned to a diet high in wholegrains and legumes or to a control diet based on the New Zealand food pyramid
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Overweight
664
0
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Condition category
Condition code
Diet and Nutrition
737
737
0
0
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Dietary counselling for 6 months, followed by regular weigh-ins for 12 months
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Intervention code [1]
486
0
Lifestyle
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Comparator / control treatment
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Control group
Active
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Outcomes
Primary outcome [1]
911
0
Weight loss
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Assessment method [1]
911
0
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Timepoint [1]
911
0
At 6 and 18 months
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Secondary outcome [1]
1767
0
Blood lipids
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Assessment method [1]
1767
0
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Timepoint [1]
1767
0
At 6 and 18 months.
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Eligibility
Key inclusion criteria
Overweight. Normal glucose tolerance.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
No exclusion criteria
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centrally generated, concealed until treatment
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin toss, unstratified
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
1/05/2005
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
207
0
New Zealand
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State/province [1]
207
0
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Funding & Sponsors
Funding source category [1]
818
0
Commercial sector/Industry
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Name [1]
818
0
Crop and Food Research Limited
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Address [1]
818
0
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Country [1]
818
0
New Zealand
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Primary sponsor type
University
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Name
University of Otago
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Address
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Country
New Zealand
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Secondary sponsor category [1]
684
0
Commercial sector/Industry
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Name [1]
684
0
Crop and Food Research Limited
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Address [1]
684
0
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Country [1]
684
0
New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
2085
0
University of Otago
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Ethics committee address [1]
2085
0
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Ethics committee country [1]
2085
0
New Zealand
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Date submitted for ethics approval [1]
2085
0
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Approval date [1]
2085
0
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Ethics approval number [1]
2085
0
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Summary
Brief summary
Weight loss trial over 18 months in overweight people with an initial body mass index of > 28 kg/m2. Advice given to follow one of 2 dietary patterns; adherence to the NZ food pyramid or a diet high in wholegrains and legumes.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
35525
0
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Address
35525
0
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Country
35525
0
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Phone
35525
0
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Fax
35525
0
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Email
35525
0
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Contact person for public queries
Name
9675
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Bernard Venn
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Address
9675
0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9001
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Country
9675
0
New Zealand
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Phone
9675
0
+64 3 4797299
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Fax
9675
0
+64 3 4797958
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Email
9675
0
[email protected]
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Contact person for scientific queries
Name
603
0
Bernard Venn
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Address
603
0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9001
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Country
603
0
New Zealand
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Phone
603
0
+64 3 4797299
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Fax
603
0
+64 3 4797958
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Email
603
0
[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Low glycaemic index or low glycaemic load diets for people with overweight or obesity.
2023
https://dx.doi.org/10.1002/14651858.CD005105.pub3
N.B. These documents automatically identified may not have been verified by the study sponsor.
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