Can we prevent Crohn's disease: a National study

ISRCTN	ISRCTN21633644
DOI	https://doi.org/10.1186/ISRCTN21633644
Protocol serial number	G0500274
Sponsor	King's College London (UK)
Funder	Medical Research Council - Health Services and Public Health Research Board (HSPHRB; ref G0500274) (UK)

Submission date: 01/03/2006
Registration date: 26/04/2006
Last edited: 19/09/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Theresa M Marteau
Scientific

Health Psychology Section
Department of Psychology (at Guy's)
5th Floor Thomas Guy House
Guy's Campus
London
SE1 9RT
United Kingdom

Study information

Primary study design	Interventional
Study design	Parallel group randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Assessing and reducing risk of Crohn's disease in smokers
Study acronym	GRAB
Study objectives	Current hypothesis as of 28/04/2008: The trial objective is to describe the impact upon motivation to stop smoking using genotype to assess risk of developing Crohn's disease (CD). The primary hypothesis is that participants are more likely to make smoking cessation attempt following the communication of their risk of developing CD that incorporates genotype analysis in addition to family history and smoking status, compared with a communication of risk of CD that does not incorporate genotype analysis. Previous hypothesis: The trial objective is to describe the impact upon motivation to stop smoking using genotype to assess risk of developing Crohn's disease. The primary hypothesis: a higher proportion of participants will engage in one or more quit-related behaviours over the six months since the intervention.
Ethics approval(s)	Ethics approval receive from the Hertfordshire Research Ethics Committee on the 26th June 2006 (ref: 06/Q0201/19). Most recent Substantial Amendment (5.0): 9th October 2007.
Health condition(s) or problem(s) studied	Crohn's disease
Intervention	The trial objective is to describe the impact upon motivation to stop smoking of using genotype to assess risk of developing Crohn's disease. We will compare the impact of risk assessment based on family history and DNA testing versus assessment based on family history alone.
Intervention type	Other
Primary outcome measure(s)	Current primary outcome as of 28/04/2008: Stopping smoking for 24 hours or longer in the six months following provision of risk information. Previous primary outcome: The proportion of participants in each group engaging in 1 or more quit-related behaviours, measured 6 months after participants are presented with their personalised risk information.
Key secondary outcome measure(s)	The proportion of participants in each group who make smoking quit attempts of 6 or more days duration. This will be validated using questionnaires and biochemical indices.
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	500
Key inclusion criteria	1. First degree relatives of patients with Crohn's disease 2. Aged over 18 years 3. Living in the British Isles 4. Without a diagnosis of Crohn's disease or ulcerative colitis 5. Male or female 6. Smoke 5 or more cigarettes daily 7. Able to give informed consent to participate 8. Able to complete, either alone or with assistance, the study questionnaires
Key exclusion criteria	Those not meeting the inclusion criteria
Date of first enrolment	01/01/2006
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Health Psychology Section

London
SE1 9RT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/07/2012		Yes	No
Protocol article	protocol	19/01/2011		Yes	No