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

ISRCTN	ISRCTN92551397
DOI	https://doi.org/10.1186/ISRCTN92551397
Protocol serial number	N/A
Sponsor	Medical Research Council (UK)
Funder	Medical Research Council (UK)

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 of protocol

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

Primary study design	Interventional
Study design	Cohort study with randomisation to one of four different physical activity feedback groups (following participation in the Fenland Study)
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	FAB
Study objectives	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 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)
Health condition(s) or problem(s) studied	Physical activity behaviour
Intervention	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
Intervention type	Other
Primary outcome measure(s)	Objectively measured physical activity over 1 week (one month post-feedback), using a combined heart rate and movement sensor.
Key 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)
Completion date	03/06/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	400
Key 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
Key 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
Date of first enrolment	03/09/2007
Date of final enrolment	03/06/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

MRC Epidemiology Unit

Cambridge
CB2 0QQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

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