Can we prevent Crohn's disease: a National study
| ISRCTN | ISRCTN21633644 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21633644 |
| Secondary identifying numbers | G0500274 |
- 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
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
| Study design | Parallel group randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/01/2006 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Health Psychology Section
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Institute of Psychiatry
De Crespigny Park
London
WC2R 2LS
England
United Kingdom
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
Research council
Medical Research Council - Health Services and Public Health Research Board (HSPHRB; ref G0500274) (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 19/01/2011 | Yes | No | |
| Results article | results | 20/07/2012 | Yes | No |
