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Trial registered on ANZCTR


Registration number
ACTRN12609001081202
Ethics application status
Approved
Date submitted
16/12/2009
Date registered
16/12/2009
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An efficacy trial of lifestyle risk factor management delivered by generalist community nurses
Scientific title
The efficacy of brief lifestyle intervention in changing multiple behavioural risk factors in clients attending generalist community nursing services: A quasi-experimental study
Secondary ID [1] 1205 0
None
Universal Trial Number (UTN)
U1111-1112-9090
Trial acronym
CN SNAP trial (Community nursing smoking, nutrition, alcohol and physical activity)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
smoking in clients attending generalist community nursing services 256395 0
diet in clients attending generalist community nursing services 256396 0
'at-risk' alcohol consumption in clients attending generalist community nursing services 256397 0
physical activity in clients attending generalist community nursing services 256398 0
Condition category
Condition code
Public Health 256574 256574 0 0
Health promotion/education
Public Health 256575 256575 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clinician-level intervention: A one day training program for participating nurses, the integration of standard screening tools and prompts for SNAP risk factors into the service specific standard assessment process used by the nurses, the development and dissemination of resources including a local service referral directory for lifestyle risk factors, a written guide for nurses, written action plans for use with clients, tape measures for measuring waist circumference, and pedometers to loan out to clients to promote self monitoring.

Client level intervention: Brief lifestyle counselling based on the 5As model tailored to the clients readiness change. The 5As model consists of assessing risk factors, advising on recommendations, agreeing goals for change, assisting with strategies for change and arranging referral to support services for more intensive intervention where appropriate
Intervention code [1] 255696 0
Lifestyle
Intervention code [2] 255697 0
Behaviour
Comparator / control treatment
Usual care provided by generalist community nurses. This consists of a comprehensive assessment (including asking about lifestyle risk factors) and clinical service provision (eg wound management). As part of usual care nurses may refer clients with lifestyle risk factors to support services but do not typically provide intervention themselves
Control group
Active

Outcomes
Primary outcome [1] 257465 0
The number and % of high risk clients offered evidence based interventions to modify their risk factors
Timepoint [1] 257465 0
3 and 6 months from baseline
Primary outcome [2] 257466 0
Change in mean physical activity scores as measured by a brief validated physical activity tool
Timepoint [2] 257466 0
3 and 6 months from baseline
Primary outcome [3] 257467 0
Change in mean alcohol intake score as measured by the validated AUDIT-C tool
Timepoint [3] 257467 0
3 and 6 months from baseline
Primary outcome [4] 257468 0
Change in mean number of serves of fruit and vegetables as measured by validated questions from the NSW Health survey
Timepoint [4] 257468 0
3 and 6 months from baseline
Primary outcome [5] 257469 0
Mean self reported weight change
Timepoint [5] 257469 0
3 and 6 months from baseline
Secondary outcome [1] 262645 0
Change in the number and percentage of clients who report smoking
Timepoint [1] 262645 0
3 and 6 months from baseline
Secondary outcome [2] 262646 0
Change in number and percentage of clients reporting adequate levels of physical activity
Timepoint [2] 262646 0
3 and 6 months from baseline
Secondary outcome [3] 262647 0
Change in the number and percentage of clients reporting ?at risk? alcohol consumption
Timepoint [3] 262647 0
3 and 6 months from baseline
Secondary outcome [4] 262648 0
Change in the number and percentage of clients consuming >=2 serves of fruit and >=5 serves of vegetables per day
Timepoint [4] 262648 0
3 and 6 months from baseline
Secondary outcome [5] 262649 0
Change in nurse self reported SNAP risk factor assessment and management scores
Timepoint [5] 262649 0
6 and 12 months from baseline

Eligibility
Key inclusion criteria
Clients referred to participating generalist community nursing services, age 30-80 years, able to read and understand English at a level that enables the client to participate in a telephone administered survey and to understand the participant information sheet.
Minimum age
30 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Palliative care clients, clients receiving one off visit or service, clients with significant cognitive impairment (unable to complete telephone administer survey), clients who are currently receiving help in changing their lifestyle from a health professional (other than their general practitioner) such as a dietitian or exercise physiologist, clients who are currently attending a chronic disease management program such as cardiac rehabilitation, diabetes education program, clients who have attended the generalist community nursing service in the previous six months (and therefore may have already received lifestyle intervention)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2359 0
2283
Recruitment postcode(s) [2] 2357 0
2300
Recruitment postcode(s) [3] 2358 0
2302
Recruitment postcode(s) [4] 2353 0
2320
Recruitment postcode(s) [5] 2354 0
2323
Recruitment postcode(s) [6] 2355 0
2325
Recruitment postcode(s) [7] 2356 0
2327
Recruitment postcode(s) [8] 2352 0
2330
Recruitment postcode(s) [9] 2361 0
2528
Recruitment postcode(s) [10] 2360 0
2530
Recruitment postcode(s) [11] 2364 0
2539
Recruitment postcode(s) [12] 2363 0
2540
Recruitment postcode(s) [13] 2362 0
2541
Recruitment postcode(s) [14] 2366 0
2560
Recruitment postcode(s) [15] 2367 0
2570
Recruitment postcode(s) [16] 2365 0
2576

Funding & Sponsors
Funding source category [1] 256180 0
Government body
Name [1] 256180 0
NSW Department of Health
Address [1] 256180 0
NSW Department of Health
Miller St
North Sydney
NSW 2060
Country [1] 256180 0
Australia
Primary sponsor type
University
Name
Centre for Primary Health Care and Equity, University of New South Wales
Address
Centre for Primary Health Care and Equity, Australian Graduate School of Management Building, University of New South Wales. NSW, Australia, 2052.
Country
Australia
Secondary sponsor category [1] 251523 0
Government body
Name [1] 251523 0
Sydney South West Area Health Service
Address [1] 251523 0
Private Mail bag 17
Liverpool NSW
BC 1871
Country [1] 251523 0
Australia
Secondary sponsor category [2] 251524 0
Government body
Name [2] 251524 0
South Eastern Sydney Illawarra Area Health Service
Address [2] 251524 0
Locked Mail Bag 8808
SCMC NSW 2521
Country [2] 251524 0
Australia
Secondary sponsor category [3] 251525 0
Government body
Name [3] 251525 0
Hunter New England Area Health Service
Address [3] 251525 0
Locked Bag 1
New Lambton NSW 2305
Australia
Country [3] 251525 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258287 0
Hunter New England Health Human Research Ethics Committee
Ethics committee address [1] 258287 0
Hunter New England Health
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 258287 0
Australia
Date submitted for ethics approval [1] 258287 0
Approval date [1] 258287 0
Ethics approval number [1] 258287 0
08/10/15/4.03

Summary
Brief summary
This study aims to evaluate the impact of a brief intervention delivered by community nurses in routine practice on the change in clients’ lifestyle risk factors.The trial will use a quasi experimental design involving four generalist community nursing sites in NSW Australia. Sites will be randomly allocated to ‘early intervention’ group or ‘late intervention’ (comparison) group. ‘Early intervention’ sites will be provided with training and support for nurses in identifying and offering brief lifestyle intervention for clients during routine consultations. ‘Late intervention’ sites’ will provide usual care and be offered the study intervention following the final data collection point. A total of 720 eligible generalist community nursing clients will be recruited at the time of referral from both early and late intervention sites. Data collection consists of 1) telephone surveys with clients at baseline, three months and six months to examine change in SNAP risk factors and readiness change 2) nurse survey at baseline, six and 12 months to examine changes in SNAP risk factor confidence, attitudes and practices 3) semi-structured interviews/focus with nurses, managers and clients in ‘early intervention’ sites to explore the feasibility, acceptability and sustainability of the intervention.

The study will provide evidence about the effectiveness and feasibility of brief lifestyle interventions delivered by generalist community nurses as part of routine practice. This will inform future community nursing practice and Primary health care (PHC) policy.
Trial website
http://notes.med.unsw.edu.au/CPHCEWeb.nsf/page/Community+Nursing+SNAP+Trial
Trial related presentations / publications
Nil to date
Public notes

Contacts
Principal investigator
Name 30617 0
Address 30617 0
Country 30617 0
Phone 30617 0
Fax 30617 0
Email 30617 0
Contact person for public queries
Name 13864 0
Dr Bibiana Chan
Address 13864 0
Centre for Primary Health Care and Equity
AGSM Building
UNSW
Sydney NSW 2052
Country 13864 0
Australia
Phone 13864 0
+61293858381
Fax 13864 0
+61293851513
Email 13864 0
bibi.chan@unsw.edu.au
Contact person for scientific queries
Name 4792 0
Prof Mark Harris
Address 4792 0
Centre for Primary Health Care and Equity
AGSM Building
UNSW
Sydney NSW 2052
Country 4792 0
Australia
Phone 4792 0
+61293858384
Fax 4792 0
+61293851513
Email 4792 0
m.f.harris@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
No Results