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The Diabetes Risk Communication Trial (DRCT)
ISRCTN ISRCTN09650496
DOI 10.1186/ISRCTN09650496
ClinicalTrials.gov identifier
EudraCT number
Public title The Diabetes Risk Communication Trial (DRCT)
Scientific title Effect of communicating genetic and phenotypic risk for type 2 diabetes in combination with lifestyle advice on objectively measured physical activity: a randomised controlled trial
Acronym DRCT
Serial number at source R100621/136
Study hypothesis The primary objective of the DRCT is to assess the effects of providing:
1. A genetic risk estimate for type 2 diabetes in combination with standard lifestyle advice
and
2. A phenotypic risk estimate for type 2 diabetes in combination with standard lifestyle advice on objectively measured physical activity
Lay summary Not provided at time of registration
Ethics approval Full ethical approval was obtained from the Cambridgeshire 1 Research Ethics Committee on 21/10/2010, reference number 10/H0304/78
Study design Parallel group randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Type 2 diabetes/ physical activity/ risk communication
Participants - inclusion criteria Residents of Cambridgeshire, in the east of England, born between 1950 and 1975, are potentially eligible to participate in the Fenland Study. Participants of the Fenland Study are invited to take part in the DRCT if they:
1. Agreed to be contacted regarding potential involvement in future studies
2. Provided sufficient data to calculate genetic and phenotypic risk estimates for type 2 diabetes
3. Wore an Actiheart® for 3 or more full days without experiencing a severe rash
4. Returned an Actiheart® that recorded 36 or more hours of total data
Participants - exclusion criteria Residents of Cambridgeshire are excluded from the Fenland Study by their GP if they:
1. Have diagnosed diabetes
2. Have a medical condition with a prognosis of less than 1 year
3. Suffer from psychotic illness
4. Are pregnant or lactating
5. Are unable to walk unaided

After participating in the Fenland Study, participants are excluded from the DRCT if they:
1. Have diagnosed diabetes
2. Are actively participating in another study
Anticipated start date 11/02/2011
Anticipated end date 11/02/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants We aim to collect outcome data on approximately 465 participants. Thus, assuming a 20% attrition rate, we will randomise approximately 580 participants in total.
Interventions Participants are randomly allocated to one of three groups:

Intervention Group A: Participants receive a genetic risk estimate for type 2 diabetes based on 23 single nucleotide polymorphisms

Intervention Group B: Participants receive a phenotypic risk estimate based on age, sex, body mass index, family history of diabetes, smoking status, and prescription of steroid or anti-hypertensive medication

Control Group: Participants do not receive either of the risk estimates until after they have completed follow-up

Each group will receive standard lifestyle advice, which includes general information about type 2 diabetes as well as information about how to reduce the risk of developing the disease.
Primary outcome measure(s) Objectively measured physical activity energy expenditure over 1 week (8 weeks post-intervention), assessed using an Actiheart®.
Secondary outcome measure(s) 1. Self-reported diet
2. Self-reported weight
3. Intentions to be physically active and to engage in a healthy diet
4. Anxiety
5. Diabetes-related worry
6. Self-rated health
7. Self-reported sedentary behaviour
8. Cognitive and emotional theory-based antecedents to health behaviour change
Sources of funding Medical Research Council (UK) Ref. R100621/136
Trial website
Publications 1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22708638
Contact name Dr  Simon  Griffin
  Address Institute of Metabolic Science
Box 285
Addenbrooke's Hospital
Hills Road
  City/town Cambridge
  Zip/Postcode CB2 0QQ
  Country United Kingdom
  Tel +44 (0)122 333 0315
  Email simon.griffin@mrc-epid.cam.ac.uk
Sponsor Medical Research Council (UK)
  Address 14th Floor
One Kemble Street
  City/town London
  Zip/Postcode WC2B 4AN
  Country United Kingdom
  Tel +44 (0)179 341 6200
  Email corporate@headoffice.mrc.ac.uk
  Sponsor website: http://www.mrc.ac.uk/index.htm
Date applied 05/04/2011
Last edited 24/01/2013
Date ISRCTN assigned 10/06/2011
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