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
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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
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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.
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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.
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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.