Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/08/2007
Date assigned
11/09/2007
Last edited
27/09/2013
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

Dr Simon Griffin

ORCID ID

Contact details

MRC Epidemiology Unit
Institute of Metabolic Science
Box 285
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 330 315
simon.griffin@mrc-epid.cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

FAB

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

More details can be found at: http://www.mrc-epid.cam.ac.uk/Research/Studies/FAB/index.html

Ethics approval

Full ethical approval received from Cambridgshire 2 Research Ethics Committee on 03/05/2007 (ref: 07/Q0108/79)

Study design

Cohort study with randomisation to one of four different physical activity feedback groups (following participation in the Fenland Study)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Objectively measured physical activity over 1 week (one month post-feedback), using a combined heart rate and movement sensor.

Secondary outcome measures

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)

Overall trial start date

03/09/2007

Overall trial end date

03/06/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400 (100 per group)

Participant 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

Recruitment start date

03/09/2007

Recruitment end date

03/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Epidemiology Unit
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Medical Research Council (UK)

Sponsor details

Medical Research Council Head OFfice
20 Park Crescent
London
W1B 1AL
United Kingdom
corporate@headoffice.mrc.ac.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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. 2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20298560
2. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24066178

Publication citations

  1. Protocol

    Watkinson C, van Sluijs EM, Sutton S, Marteau T, Griffin SJ, Randomised controlled trial of the effects of physical activity feedback on awareness and behaviour in UK adults: the FAB study protocol [ISRCTN92551397]., BMC Public Health, 2010, 10, 1, 144, doi: 10.1186/1471-2458-10-144.

  2. Results

    Godino JG, Watkinson C, Corder K, Marteau TM, Sutton S, Sharp SJ, Griffin SJ, van Sluijs EM, Impact of personalised feedback about physical activity on change in objectively measured physical activity (the FAB study): a randomised controlled trial., PLoS ONE, 2013, 8, 9, e75398, doi: 10.1371/journal.pone.0075398.

Additional files

Editorial Notes