Contact information
Type
Scientific
Primary contact
Dr Simon Griffin
ORCID ID
Contact details
Institute of Metabolic Science
Box 285
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)122 333 0315
simon.griffin@mrc-epid.cam.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R100621/136
Study information
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
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
Ethics approval
Cambridgeshire 1 Research Ethics Committee, 21/10/2010, ref: 10/H0304/78
Study design
Parallel-group randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Type 2 diabetes/physical activity/risk communication
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Objectively measured physical activity energy expenditure over 1 week (8 weeks post-intervention), assessed using an Actiheart®
Secondary outcome measures
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
Overall trial start date
11/02/2011
Overall trial end date
11/02/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
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.
Participant 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
Recruitment start date
11/02/2011
Recruitment end date
11/02/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Organisation
Medical Research Council (UK)
Sponsor details
14th Floor
One Kemble Street
London
WC2B 4AN
United Kingdom
+44 (0)179 341 6200
corporate@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research organisation
Funder name
Medical Research Council (UK) Ref. R100621/136
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
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
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22708638
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27898672
Publication citations
-
Protocol
Godino JG, van Sluijs EM, Marteau TM, Sutton S, Sharp SJ, Griffin SJ, Effect of communicating genetic and phenotypic risk for type 2 diabetes in combination with lifestyle advice on objectively measured physical activity: protocol of a randomised controlled trial., BMC Public Health, 2012, 12, 444, doi: 10.1186/1471-2458-12-444.