Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/04/2011
Date assigned
10/06/2011
Last edited
01/12/2016
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

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

http://www.mrc.ac.uk/index.htm

Funders

Funder type

Research organisation

Funder name

Medical Research Council (UK) Ref. R100621/136

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

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22708638
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27898672

Publication citations

  1. 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.

Additional files

Editorial Notes

01/12/2016: Publication reference added.