The FAB Study: Feedback, Awareness and Behaviour in the Fenland Study

ISRCTN ISRCTN92551397
DOI https://doi.org/10.1186/ISRCTN92551397
Secondary identifying numbers N/A
Submission date
29/08/2007
Registration date
11/09/2007
Last edited
27/09/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Simon Griffin
Scientific

MRC Epidemiology Unit
Institute of Metabolic Science
Box 285
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Phone +44 (0)1223 330 315
Email simon.griffin@mrc-epid.cam.ac.uk

Study information

Study designCohort study with randomisation to one of four different physical activity feedback groups (following participation in the Fenland Study)
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymFAB
Study hypothesisAim: 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

More details can be found at: http://www.mrc-epid.cam.ac.uk/Research/Studies/FAB/index.html
Ethics approval(s)Full ethical approval received from Cambridgshire 2 Research Ethics Committee on 03/05/2007 (ref: 07/Q0108/79)
ConditionPhysical activity behaviour
InterventionThe 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
Intervention typeOther
Primary outcome measureObjectively measured physical activity over 1 week (one month post-feedback), using a combined heart rate and movement sensor.
Secondary outcome measures1. 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)
Overall study start date03/09/2007
Overall study end date03/06/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants400 (100 per group)
Participant inclusion criteria1. Aged 30-55 years
2. Registered with participating general practices in the Cambridgeshire Primary Care Trust
3. Participating in the Fenland Study
Participant exclusion criteria1. 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
Recruitment start date03/09/2007
Recruitment end date03/06/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Epidemiology Unit
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Medical Research Council (UK)
Government

Medical Research Council Head OFfice
20 Park Crescent
London
W1B 1AL
United Kingdom

Email corporate@headoffice.mrc.ac.uk
ROR logo "ROR" https://ror.org/03x94j517

Funders

Funder type

Government

Medical Research Council (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 18/03/2010 Yes No
Results article results 16/09/2013 Yes No