Condition category
Mental and Behavioural Disorders
Date applied
08/06/2006
Date assigned
11/09/2006
Last edited
22/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christopher Butler

ORCID ID

Contact details

Department of General Practice
Cardiff University
Centre for Health Sciences Research
School of Medicine
3rd Floor
Neuadd Merionnydd
Heath Park
Cardiff
CF14 4XN
United Kingdom
-
butlercc@cf.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0501283

Study information

Scientific title

Preventing disease through opportunistic, Rapid EngagEMent by Primary care Teams using behaviour change counselling

Acronym

PRE-EMPT

Study hypothesis

There are three main aims:
1. To determine whether exposing clinicians to blended learning of Behaviour Change Counselling (BCC) leads to patients making more positive changes regarding smoking, risky drinking, physical activity and unhealthy eating, and at what cost?
2. To examine if patients consulting with clinicians exposed to blended learning of Behaviour Change Counselling recall behavioural interventions more often and find them more acceptable and do they state that they intend to change more often?
3. To explore if clinicians exposed to blended learning of BCC feel more efficacious in advising on behaviour change, and committed to behaviour change counselling?

Ethics approval

Multi-centre Research Ethics Committee (MREC) for Wales, 09/05/2007, ref: 07/MRE09/11

Study design

Cluster randomised trial with randomisation at the level of general practice

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Behaviour change counselling in patients with unhealthy lifestyles

Intervention

Clinicians in the experimental group will receive training in Behaviour Change Counselling, using a blended learning, multi-method approach including on-line learning and face to face seminar sessions. Clinicians will then use this when interacting with patients around health behaviour change. The comparison group will provide usual care with the offer of training after the study period.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Proportion of patients showing important positive change in one or more of the four behaviours (smoking, alcohol use, exercise and healthy eating) at three months

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2006

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ability to provide informed consent
2. Aged 18 years and over
3. English speaking
4. Screening positive to any of the four behaviours (smoking, alcohol use, exercise and healthy eating)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24 practices (12 intervention; 12 control)

Participant exclusion criteria

1. Serious acute illness
2. Terminal illness
3. Severe psychiatric illness (as indicated by health professional)

Recruitment start date

01/10/2006

Recruitment end date

31/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiff University
Cardiff
CF14 4XN
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

Research and Commercial Division
Cardiff University
30-36 Newport Road
Cardiff
CF24 0DE
United Kingdom
-
DaviesKP2@cf.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Prevention Research Initiative (NPRI) (UK) (ref: G0501283)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20858273
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23512758
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26453044

Publication citations

  1. Protocol

    Spanou C, Simpson SA, Hood K, Edwards A, Cohen D, Rollnick S, Carter B, McCambridge J, Moore L, Randell E, Pickles T, Smith C, Lane C, Wood F, Thornton H, Butler CC, Preventing disease through opportunistic, rapid engagement by primary care teams using behaviour change counselling (PRE-EMPT): protocol for a general practice-based cluster randomised trial., BMC Fam Pract, 2010, 11, 69, doi: 10.1186/1471-2296-11-69.

  2. Results

    Butler CC, Simpson SA, Hood K, Cohen D, Pickles T, Spanou C, McCambridge J, Moore L, Randell E, Alam MF, Kinnersley P, Edwards A, Smith C, Rollnick S, Training practitioners to deliver opportunistic multiple behaviour change counselling in primary care: a cluster randomised trial., BMJ, 2013, 346, f1191.

  3. Results

    Randell E, Pickles T, Simpson SA, Spanou C, McCambridge J, Hood K, Butler CC, Eligibility for interventions, co-occurrence and risk factors for unhealthy behaviours in patients consulting for routine primary care: results from the Pre-Empt study, BMC Fam Pract, 2015 , 16, 133, doi: 10.1186/s12875-015-0359-x.

Additional files

Editorial Notes

22/06/2016: Publication reference added. 15/07/2010: the overall trial end date was changed from 30/11/2009 to 31/12/2010.