Trial Review

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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
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 664 0
Condition category
Condition code
Diet and Nutrition 737 737 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dietary counselling for 6 months, followed by regular weigh-ins for 12 months
Intervention code [1] 486 0
Lifestyle
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 911 0
Weight loss
Timepoint [1] 911 0
At 6 and 18 months
Secondary outcome [1] 1767 0
Blood lipids
Timepoint [1] 1767 0
At 6 and 18 months.

Eligibility
Key inclusion criteria
Overweight. Normal glucose tolerance.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centrally generated, concealed until treatment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin toss, unstratified
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 207 0
New Zealand
State/province [1] 207 0

Funding & Sponsors
Funding source category [1] 818 0
Commercial sector/Industry
Name [1] 818 0
Crop and Food Research Limited
Country [1] 818 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 684 0
Commercial sector/Industry
Name [1] 684 0
Crop and Food Research Limited
Address [1] 684 0
Country [1] 684 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2085 0
University of Otago
Ethics committee address [1] 2085 0
Ethics committee country [1] 2085 0
New Zealand
Date submitted for ethics approval [1] 2085 0
Approval date [1] 2085 0
Ethics approval number [1] 2085 0

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

Contacts
Principal investigator
Name 35525 0
Address 35525 0
Country 35525 0
Phone 35525 0
Fax 35525 0
Email 35525 0
Contact person for public queries
Name 9675 0
Bernard Venn
Address 9675 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9001
Country 9675 0
New Zealand
Phone 9675 0
+64 3 4797299
Fax 9675 0
+64 3 4797958
Email 9675 0
bernard.venn@stonebow.otago.ac.nz
Contact person for scientific queries
Name 603 0
Bernard Venn
Address 603 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9001
Country 603 0
New Zealand
Phone 603 0
+64 3 4797299
Fax 603 0
+64 3 4797958
Email 603 0
bernard.venn@stonebow.otago.ac.nz

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
EmbaseLow glycaemic index or low glycaemic load diets for people with overweight or obesity.2023https://dx.doi.org/10.1002/14651858.CD005105.pub3
N.B. These documents automatically identified may not have been verified by the study sponsor.