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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]

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

diet in clients attending generalist community nursing services

'at-risk' alcohol consumption in clients attending generalist community nursing services

physical activity in clients attending generalist community nursing services

Condition category

Condition code

Public Health

Health promotion/education

Public Health

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]

Lifestyle

Intervention code [2]

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]

The number and % of high risk clients offered evidence based interventions to modify their risk factors

Timepoint [1]

3 and 6 months from baseline

Primary outcome [2]

Change in mean physical activity scores as measured by a brief validated physical activity tool

Timepoint [2]

3 and 6 months from baseline

Primary outcome [3]

Change in mean alcohol intake score as measured by the validated AUDIT-C tool

Timepoint [3]

3 and 6 months from baseline

Primary outcome [4]

Change in mean number of serves of fruit and vegetables as measured by validated questions from the NSW Health survey

Timepoint [4]

3 and 6 months from baseline

Primary outcome [5]

Mean self reported weight change

Timepoint [5]

3 and 6 months from baseline

Secondary outcome [1]

Change in the number and percentage of clients who report smoking

Timepoint [1]

3 and 6 months from baseline

Secondary outcome [2]

Change in number and percentage of clients reporting adequate levels of physical activity

Timepoint [2]

3 and 6 months from baseline

Secondary outcome [3]

Change in the number and percentage of clients reporting ?at risk? alcohol consumption

Timepoint [3]

3 and 6 months from baseline

Secondary outcome [4]

Change in the number and percentage of clients consuming >=2 serves of fruit and >=5 serves of vegetables per day

Timepoint [4]

3 and 6 months from baseline

Secondary outcome [5]

Change in nurse self reported SNAP risk factor assessment and management scores

Timepoint [5]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/03/2009

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

720

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

2330

Recruitment postcode(s) [2]

2320

Recruitment postcode(s) [3]

2323

Recruitment postcode(s) [4]

2325

Recruitment postcode(s) [5]

2327

Recruitment postcode(s) [6]

2300

Recruitment postcode(s) [7]

2302

Recruitment postcode(s) [8]

2283

Recruitment postcode(s) [9]

2530

Recruitment postcode(s) [10]

2528

Recruitment postcode(s) [11]

2541

Recruitment postcode(s) [12]

2540

Recruitment postcode(s) [13]

2539

Recruitment postcode(s) [14]

2576

Recruitment postcode(s) [15]

2560

Recruitment postcode(s) [16]

2570

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NSW Department of Health

Address [1]

NSW Department of Health
Miller St
North Sydney
NSW 2060

Country [1]

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]

Government body

Name [1]

Sydney South West Area Health Service

Address [1]

Private Mail bag 17
Liverpool NSW
BC 1871

Country [1]

Australia

Secondary sponsor category [2]

Government body

Name [2]

South Eastern Sydney Illawarra Area Health Service

Address [2]

Locked Mail Bag 8808
SCMC NSW 2521

Country [2]

Australia

Secondary sponsor category [3]

Government body

Name [3]

Hunter New England Area Health Service

Address [3]

Locked Bag 1
New Lambton NSW 2305
Australia

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Health Human Research Ethics Committee

Ethics committee address [1]

Hunter New England Health
Locked Bag 1
New Lambton   NSW   2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Bibiana Chan

Address

Centre for Primary Health Care and Equity
AGSM Building
UNSW
Sydney NSW 2052

Country

Australia

Phone

+61293858381

Fax

+61293851513

[email protected]

Contact person for scientific queries

Name

Prof Mark Harris

Address

Centre for Primary Health Care and Equity
AGSM Building
UNSW
Sydney NSW 2052

Country

Australia

Phone

+61293858384

Fax

+61293851513

[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

Source	Title	Year of Publication	DOI
Embase	The impact of a brief lifestyle intervention delivered by generalist community nurses (CN SNAP trial).	2013	https://dx.doi.org/10.1186/1471-2458-13-375
Dimensions AI	The impact of a team-based intervention on the lifestyle risk factor management practices of community nurses: outcomes of the community nursing SNAP trial	2013	https://doi.org/10.1186/1472-6963-13-54

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically