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Can we prevent Crohn's disease: a National study
ISRCTN ISRCTN21633644
DOI 10.1186/ISRCTN21633644
ClinicalTrials.gov identifier
EudraCT number
Public title Can we prevent Crohn's disease: a National study
Scientific title Assessing and reducing risk of Crohn's disease in smokers
Acronym GRAB
Serial number at source G0500274
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval 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.
Study design Parallel group randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Crohn's disease
Participants - 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
Participants - exclusion criteria Those not meeting the inclusion criteria
Anticipated start date 01/01/2006
Anticipated end date 31/12/2009
Status of trial Completed
Patient information material
Target number of participants 500
Interventions 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.
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.
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.
Sources of funding Medical Research Council - Health Services and Public Health Research Board (HSPHRB; ref G0500274) (UK)
Trial website
Publications 1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21247480
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22822007
Contact name Prof  Theresa M  Marteau
  Address Health Psychology Section
Department of Psychology (at Guy's)
5th Floor Thomas Guy House
Guy's Campus
  City/town London
  Zip/Postcode SE1 9RT
  Country United Kingdom
Sponsor King's College London (UK)
  Address Institute of Psychiatry
De Crespigny Park
  City/town London
  Zip/Postcode WC2R 2LS
  Country United Kingdom
Date applied 01/03/2006
Last edited 19/09/2012
Date ISRCTN assigned 26/04/2006
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