Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000651684
Ethics application status
Approved
Date submitted
10/09/2005
Date registered
18/10/2005
Date last updated
18/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The 5+YourWay ® Study
Scientific title
A randomised controlled trial testing the effectiveness of 5+YourWay ® -generated individually tailored print communications to increase fruit/vegetable consumption, readiness to change, decisional balance, and self-efficacy in New Zealand adults with a low to moderate fruit and vegetable intake
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary prevention of mainly cardiovascular disease and some cancers 784 0
Condition category
Condition code
Diet and Nutrition 858 858 0 0
Public Health 859 859 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A nationally representative sample of low fruit and vegetable consumers was randomised to one of three groups for this postal intervention: the tailored group (to receive three six-weekly 5+YourWay ® -generated individually tailored print communications, representing innovative practice), the generic group (to receive three six-weekly Ministry of Health "one size fits all" print messages, representing usual practice).
Intervention code [1] 448 0
None
Comparator / control treatment
The control group (to receive no intervention).
Control group
Active

Outcomes
Primary outcome [1] 1101 0
Fruit intake
Timepoint [1] 1101 0
At baseline, 3, 6 and 12 months
Primary outcome [2] 1102 0
Vegetable intake
Timepoint [2] 1102 0
At baseline, 3, 6 and 12 months
Secondary outcome [1] 2037 0
Fruit/vegetable stage of change, self-efficacy, and decisional balance.
Timepoint [1] 2037 0
At baseline, 3, 6 and 12 months.

Eligibility
Key inclusion criteria
A nationally representative sample of New Zealanders, was drawn from the New Zealand electoral rolls and screened via a postal survey. Respondents were eligible for group assignment if they had low fruit and vegetable consumption (ie. they were not in the maintenance stage of change for both the fruit goal and the vegetable goal, or were not eating 9 or more servings of fruit and vegetables per day) and had no self-reported medical conditions preventing them from eating at least 2 fruit and 3 vegetable servings each day. Eligible respondents gave their informed consent to participate in a one-year trial, lived in New Zealand, and were not living in supervised care.
Minimum age
25 Years
Maximum age
60 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)
central randomisation by email- an independent statistician used a random allocation sequence to assign eligible subjects to intervention groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The statistician used computer software to generate the random allocation sequence. Stratified randomisation to intervention group was based on gender, age, fruit stage of change and vegetable stage of change.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1050
Accrual to date
Final
Recruitment outside Australia
Country [1] 198 0
New Zealand
State/province [1] 198 0

Funding & Sponsors
Funding source category [1] 944 0
Charities/Societies/Foundations
Name [1] 944 0
National Heart Foundation of New Zealand
Country [1] 944 0
New Zealand
Funding source category [2] 945 0
University
Name [2] 945 0
University of Otago
Country [2] 945 0
New Zealand
Primary sponsor type
Individual
Name
Louise A. Mainvil
Address
Country
Secondary sponsor category [1] 804 0
Individual
Name [1] 804 0
Silke Hellwig
Address [1] 804 0
Country [1] 804 0
Secondary sponsor category [2] 805 0
Individual
Name [2] 805 0
Grant Baxter
Address [2] 805 0
Country [2] 805 0
Secondary sponsor category [3] 806 0
Individual
Name [3] 806 0
Glennis Shelton,
Address [3] 806 0
Country [3] 806 0
Secondary sponsor category [4] 807 0
Individual
Name [4] 807 0
Caroline Horwath-Matthaei
Address [4] 807 0
Country [4] 807 0
Secondary sponsor category [5] 808 0
Individual
Name [5] 808 0
Elaine Rose
Address [5] 808 0
Country [5] 808 0
Secondary sponsor category [6] 809 0
Individual
Name [6] 809 0
Anthony Reeder
Address [6] 809 0
Country [6] 809 0
Secondary sponsor category [7] 810 0
Individual
Name [7] 810 0
Andrew Gray
Address [7] 810 0
Country [7] 810 0
Secondary sponsor category [8] 811 0
Individual
Name [8] 811 0
Christine Thomson
Address [8] 811 0
Country [8] 811 0
Secondary sponsor category [9] 812 0
Individual
Name [9] 812 0
Sian Warriner,
Address [9] 812 0
Country [9] 812 0
Secondary sponsor category [10] 813 0
Individual
Name [10] 813 0
Kylie Paterson
Address [10] 813 0
Country [10] 813 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36105 0
Address 36105 0
Country 36105 0
Phone 36105 0
Fax 36105 0
Email 36105 0
Contact person for public queries
Name 9637 0
Louise A. Mainvil
Address 9637 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9008
Country 9637 0
New Zealand
Phone 9637 0
+64 3 4795687
Fax 9637 0
Email 9637 0
[email protected]
Contact person for scientific queries
Name 565 0
Louise A. Mainvil
Address 565 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9008
Country 565 0
New Zealand
Phone 565 0
+64 3 4795687
Fax 565 0
Email 565 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.