The Diabetes Risk Communication Trial (DRCT)

ISRCTN	ISRCTN09650496
DOI	https://doi.org/10.1186/ISRCTN09650496
Secondary identifying numbers	R100621/136

Submission date: 05/04/2011
Registration date: 10/06/2011
Last edited: 01/12/2016

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

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

Phone	+44 (0)122 333 0315
Email	simon.griffin@mrc-epid.cam.ac.uk

Study information

Study design	Parallel-group randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study acronym	DRCT
Study objectives	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(s)	Cambridgeshire 1 Research Ethics Committee, 21/10/2010, ref: 10/H0304/78
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	11/02/2011
Completion date	11/02/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	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.
Key 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
Key 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
Date of first enrolment	11/02/2011
Date of final enrolment	11/02/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Addenbrooke's Hospital

Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Medical Research Council (UK)
Research council

14th Floor
One Kemble Street
London
WC2B 4AN
United Kingdom

Phone	+44 (0)179 341 6200
Email	corporate@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk/index.htm
"ROR"	https://ror.org/03x94j517

Funders

Funder type

Research organisation

Medical Research Council (UK) Ref. R100621/136
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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	18/06/2012		Yes	No
Results article	results	29/11/2016		Yes	No

Editorial Notes

01/12/2016: Publication reference added.