Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001213932
Ethics application status
Approved
Date submitted
22/11/2011
Date registered
24/11/2011
Date last updated
24/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
‘10 Small Steps’: A controlled trial of promotion of a ‘prudent’ lifestyle in a general practice adult population
Scientific title
‘10 Small Steps’: A randomised controlled trial to improve dietary and lifestyle behaviours in general practice adult population using a summary health score
Secondary ID [1] 273417 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dietary and other health Behaviours associated with increasing risk of chronic non-communicable diseases 279207 0
Condition category
Condition code
Public Health 279412 279412 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants in the intervention group received the information related to the ten health behaviours (physical activity, smoking, Body mass index, alcohol intake, vegetable and fruit intake, salt intake, meat intake, fish intake, avoidance of full fat milk and use of spreads other than butter)associated with the health behaviour score (Prudence Score) only. The intervention material consisted of:
(1) Personalised tailored feedback: The personalised tailored feedback letter encouraged the adoption of at least one further health behaviour in addition to those already being followed according to the patient’s Prudence Score. The decision as to which additional behaviour(s) to attempt was the patient’s own. All the tailored feedback to each participant was provided on the treating general practitioner’s letterhead using their electronic signature.
(2) Health Promotion Information Material: One page health promotion materials were developed and distributed only to those participants whose Prudence Score indicated they were not meeting the national guidelines for a particular behaviour. For example, participants who did not meet National Health and Medical Research Council’s guidelines for vegetable intake but did meet recommendations for fruit intake received only the information sheet related to eating 5 serves of vegetables per day.
The study was a factorial trial: firstly the participants were randomised into intervention and control groups and then further randomised to two groups: 1. Receiving feedback at baseline as well as at 3 months (dual intervention and corresponding control group) 2. Receiving feedback at baseline (Single intervention and corresponding control group)
Data were collected at 3 months after baseline to assess the effectiveness of the intervention and final data collection occurred at 12 months after baseline to measure the outcomes.
Intervention code [1] 283751 0
Prevention
Intervention code [2] 283752 0
Lifestyle
Intervention code [3] 283753 0
Behaviour
Comparator / control treatment
The control group received information on other health protective behaviours (sun protection, tetanus vaccination, passive smoking, mammogram and pap smear) which were different from the ten health behaviours included in the intervention.
Control group
Active

Outcomes
Primary outcome [1] 285997 0
Effectiveness of a computer tailored intervention aimed at promoting long-term adoption and maintenance of a healthier lifestyle in general practice population, measured as increase in the combined health score.
Timepoint [1] 285997 0
At 12 months
Primary outcome [2] 285998 0
Establishing prevalence of health behvaiours as a combined health score, the 'Prudence Score'
Timepoint [2] 285998 0
Baseline
Primary outcome [3] 285999 0
Effectiveness of the intervention measured as difference in mean health score in short term
Timepoint [3] 285999 0
3 months after delivering the intervention
Secondary outcome [1] 294979 0
Nil
Timepoint [1] 294979 0
Nil

Eligibility
Key inclusion criteria
The inclusion criteria for the general practitioners was to have an electronic record system.

For the participants inclusion ctriteria were:
1. Adult patients (18 to 70 years )
2. Visited participating general practice in past 6 months before recruitment
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Participants with severe morbidity such as active cancers, Alzheimer’s, dementia
2. Recent bereavement
3. Patients who are not deemed to be suitable by their treating GP for the above reasons

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each participating general practitioner produced a list of adult patients who visited the general practice in the past 6 months and vetted the list to exclude any patients according to the exclusion criteria.
The research team sent invitation letters to participate in the study on behalf of the general practitioners. Participants were randomised after receiving completed questionnaires.
Researcher who determined the group of an indivitual in the trial was unaware, when this decision was made, to which group the subject would be allocated. Allocation was concealed as it included selecting a sequence from a random container.
None of the participants were aware of the various study groups as data were collected on all the health behaviours from all the participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each general practitioner was used as a cluster and participants were randomised within a list from each GP.

Participants were randomised into four groups using a block randomisation method. From a container that contained multiple sequences and firstly a sequence was randomly selected. Further from each chosen sequence study group allocations took place as each questionnaire arrived from a patient of that particular GP.
This method was followed individually for each GP involved in the study except for participants sharing a residence, who were allocated to the same study group to avoid contamination of the intervention and control groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284244 0
Charities/Societies/Foundations
Name [1] 284244 0
The MBF Foundation
Country [1] 284244 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The MBF Foundation
Address
The MBF Australia
Level 2, 50 Bridge St
SYDNEY NSW 2000
Country
Australia
Secondary sponsor category [1] 269200 0
None
Name [1] 269200 0
Nil
Address [1] 269200 0
Nil
Country [1] 269200 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286208 0
Behavioural and Social Sciences Ethics Committee, University of Queensland
Ethics committee address [1] 286208 0
Ethics committee country [1] 286208 0
Australia
Date submitted for ethics approval [1] 286208 0
Approval date [1] 286208 0
02/08/2006
Ethics approval number [1] 286208 0
2006000314

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

Contacts
Principal investigator
Name 33413 0
Address 33413 0
Country 33413 0
Phone 33413 0
Fax 33413 0
Email 33413 0
Contact person for public queries
Name 16660 0
Ms Stacey Vogel
Address 16660 0
Healthy Communities Research Centre
Building 1
The University of Queensland
11 Salisbury Road
IPSWICH QLD 4305
Country 16660 0
Australia
Phone 16660 0
+61 7 338 11379
Fax 16660 0
+61 7 338 11056
Email 16660 0
[email protected]
Contact person for scientific queries
Name 7588 0
Dr Sanjoti Parekh
Address 7588 0
Healthy Communities Research Centre
Building 1
The University of Queensland
11 Salisbury Road
IPSWICH QLD 4305
Country 7588 0
Australia
Phone 7588 0
+61 7 338 11379
Fax 7588 0
+61 7 338 11056
Email 7588 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.