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| [ ...Back to search results ] | [ Print-friendly version ] |
| The FAB Study: Feedback, Awareness and Behaviour in the Fenland Study |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN92551397 |
| Date ISRCTN assigned | 11/09/2007 |
| Local reference number(s) | N/A |
| Public title | The FAB Study: Feedback, Awareness and Behaviour in the Fenland Study |
| Scientific title | |
| Acronym | FAB |
| Disease/condition/study domain | Physical activity behaviour |
| Study hypothesis | Aim: To quantify the effect of measurement and feedback on physical activity behaviour Measurement objectives: 1. Self awareness of physical activity levels 2. Effect of measurement on awareness 3. Effect of feedback on awareness and intentions 4. Effect of feedback on behaviour 5. Level of false reassurance |
| Design/methodology | Cohort study with randomisation to one of four different physical activity feedback groups (following participation in the Fenland Study) |
| Research ethics review | Full ethical approval received from Cambridgshire 2 Research Ethics Committee on 03/05/2007 (ref: 07/Q0108/79) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Aged 30-55 years 2. Registered with participating general practices in the Cambridgeshire Primary Care Trust 3. Participating in the Fenland Study |
| Participants - exclusion criteria | 1. Have diagnosed diabetes 2. Have a terminal illness with a prognosis of less than 1 year 3. Suffer from psychotic illness 4. Are pregnant or lactating 5. Are unable to walk unaided |
| Patient information material | |
| Anticipated start date | 03/09/2007 |
| Anticipated end date | 03/06/2008 |
| Status of trial | Ongoing |
| Target number of participants | 400 (100 per group) |
| Interventions | The FAB Study has been set up as a nested cohort study within the Fenland Study, but with a very different purpose, and with separate ethical approval. Volunteers in the Fenland Study have agreed to undergo oral glucose tolerance test and precise measurement of body anthropometry, body composition and physical activity over a one-week period (using individually calibrated Actihearts which measure heart rate and movement). Those who volunteer for FAB are randomly allocated to one of four groups: Group 1: Control group - no feedback Group 2: Physical activity feedback type A - Physical Activity Level (PAL) Group 3: Physical activity feedback type B - PAL + daily heart rate and movement printouts Group 4: Physical activity feedback type C - PAL + daily heart rate and movement printouts + goal setting and modelling information |
| Primary outcome measure(s) | Objectively measured physical activity over 1 week (one month post-feedback), using a combined heart rate and movement sensor. |
| Secondary outcome measure(s) | 1. Self-reported physical activity - RPAQ (baseline, and 1 month after feedback) 2. Self-rated physical activity (baseline, immediately after feedback, and 1 month after feedback) 3. Worry about own physical activity (baseline, immediately after feedback, and 1 month after feedback) 4. Physical activity outcome expectations (baseline, immediately after feedback, and 1 month after feedback) 5. Physical activity self-efficacy (baseline, immediately after feedback, and 1 month after feedback) 6. Intention to change physical activity (baseline, immediately after feedback, and 1 month after feedback) 7. Time orientation (baseline only) |
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | Medical Research Council Head OFfice 20 Park Crescent London United Kingdom W1B 1AL |
| Sponsor email | corporate@headoffice.mrc.ac.uk |
| Contact name | Dr Simon Griffin |
| Contact details | MRC Epidemiology Unit Institute of Metabolic Science Box 285 Addenbrooke's Hospital Hills Road Cambridge United Kingdom CB2 0QQ |
| Contact telephone | +44 (0)1223 330 315 |
| Contact email | simon.griffin@mrc-epid.cam.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN92551397 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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