Condition category
Digestive System
Date applied
01/03/2006
Date assigned
26/04/2006
Last edited
19/09/2012
Prospective/Retrospective
Retrospectively 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 Theresa M Marteau

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0500274

Study information

Scientific title

Assessing and reducing risk of Crohn's disease in smokers

Acronym

GRAB

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/01/2006

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

Those not meeting the inclusion criteria

Recruitment start date

01/01/2006

Recruitment end date

31/12/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Health Psychology Section
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Institute of Psychiatry
De Crespigny Park
London
WC2R 2LS
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Medical Research Council - Health Services and Public Health Research Board (HSPHRB; ref G0500274) (UK)

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

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21247480
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22822007

Publication citations

  1. Protocol

    Whitwell SC, Mathew CG, Lewis CM, Forbes A, Watts S, Sanderson J, Hollands GJ, Prevost AT, Armstrong D, Kinmonth AL, Sutton S, Marteau TM, Trial Protocol: Communicating DNA-based risk assessments for Crohn's disease: a randomised controlled trial assessing impact upon stopping smoking., BMC Public Health, 2011, 11, 44, doi: 10.1186/1471-2458-11-44.

  2. Results

    Hollands GJ, Whitwell SC, Parker RA, Prescott NJ, Forbes A, Sanderson J, Mathew CG, Lewis CM, Watts S, Sutton S, Armstrong D, Kinmonth AL, Prevost AT, Marteau TM, Effect of communicating DNA based risk assessments for Crohn's disease on smoking cessation: randomised controlled trial., BMJ, 2012, 345, e4708.

Additional files

Editorial Notes