Delivering the Diabetes Prevention Programme in a UK community setting: UEA-IFG Study

ISRCTN	ISRCTN06589959
DOI	https://doi.org/10.1186/ISRCTN06589959
Secondary identifying numbers	4832

Submission date: 24/06/2010
Registration date: 24/06/2010
Last edited: 03/02/2020

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

Not provided at time of registration

Contact information

Prof Mike Sampson
Scientific

Colney Lane
Norwich
NR4 7UY
United Kingdom

ORCID ID	0000-0002-1433-2319
Phone	+44 01603 297094
Email	mike.sampson@nnuh.nhs.uk

Study information

Study design	Single centre randomised interventional prevention and screening trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Scientific title	Delivering the Diabetes Prevention Programme in a UK community setting: UEA-IFG Study
Study acronym	DRN135 (Diabetes Prevention Programme: UEA-IFG Study)
Study hypothesis	This two year feasibility programme will screen for participants at risk of diabetes (impaired fasting glucose). For those participants at risk of diabetes, the second stage of the programme will be to investigate whether a structured diet and lifestyle programme (called UEA-IFG) can be developed and whether the programme reduces the risk of Type 2 Diabetes Mellitus. The end stage would be to develop a full RCT to test the intervention programme fully.
Ethics approval(s)	MREC approved (ref: 08/H0301/102)
Condition	Topic: Diabetes Research Network, Primary Care Research Network for England; Subtopic: Type 2, Not Assigned; Disease: All Diseases, Prevention/screening
Intervention	Diabetes Prevention Programme: Lifestyle programme based on the U.S. Diabetes Prevention Programme. Participant targets will be to: 1. Lose 7% of body weight 2. Build up to 2.5 hours of brisk physical activity each week 3. Build up to walking at least 10,000 steps a day 4. Eat more healthily by eating less fat Study entry: single randomisation only
Intervention type	Other
Primary outcome measure	Transition to type 2 diabetes mellitus (fasting plasma glucose of 7.0 mmol/l or greater) after 17 months
Secondary outcome measures	Not provided at time of registration
Overall study start date	08/12/2008
Overall study end date	14/01/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned sample size: 870; UK sample size: 870
Participant inclusion criteria	1. Male or female 2. Aged 45 - 70 years 3. One of the following: 3.1. First degree relative with type 2 diabetes 3.2. Body mass index (BMI) greater than 25 kg/m2 3.3. Waist circumference greater than 94 cm (male) or greater than 80 cm (female) 3.4. History of gestational diabetes 3.5. History of coronary heart disease
Participant exclusion criteria	Does not meet inclusion criteria
Recruitment start date	08/12/2008
Recruitment end date	14/01/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Colney Lane

Norwich
NR4 7UY
United Kingdom

Sponsor information

Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Colney Lane
Colney
Norwich
NR4 7UY
England
United Kingdom

Website	http://www.nnuh.nhs.uk/
"ROR"	https://ror.org/01wspv808

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR)

No information available

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?
Results article	results	01/05/2012	30/01/2020	Yes	No

Editorial Notes

03/02/2020: The scientific contact has been updated.
30/01/2020: Publication reference added.