Lifestyle change in individuals at risk of diabetes and heart disease

ISRCTN	ISRCTN77825185
DOI	https://doi.org/10.1186/ISRCTN77825185
Protocol serial number	N0203178114
Sponsor	Devon Primary Care Trust (UK)
Funders	Royal Devon and Exeter NHS Trust (UK), Mid Devon Primary Care Research Group (UK), NHS Research and Development Support Funding (UK)

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 03/02/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mark Daly
Scientific

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom

Phone	+44 (0)1392 403086

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To see whether lifestyle behaviour changes (weight loss and increased physical activity) similar to those obtained in recent large Finnish and US studies can be achieved with a simplified lifestyle intervention in a UK primary care setting. The intervention will use motivational interviewing (a well established, patient-centered behaviour counselling technique), delivered by trained health promotion worker (not necessarily existing NHS staff).
Ethics approval(s)	Ethics approval added as of 16/07/2007: North & East Devon Local Research Ethics Committee, approved in 2005 (ref: 05/Q2102/40)
Health condition(s) or problem(s) studied	Diabetes and heart disease
Intervention	Please note that the amendments to the target number of participants and participants - inclusion criteria (both amended as of 12/10/2007) reflect errors in information provided at time of registration, not changes in protocol. Interventions added as of 16/07/2007: 1. Intervention group: Motivational interviews (patient-centered behaviour counseling) delivered by trained health promotion worker 2. Control group: Information leaflets offering advice on healthy eating and the benefits of increased physical activity
Intervention type	Other
Primary outcome measure(s)	Proportion of people achieving specific targets for weight change and physical activity which have been shown to be beneficial in previous studies.
Key secondary outcome measure(s)	Secondary outcome measures added as of 16/07/2007: 1. The proportion of participants achieving 150 min moderate activity per week 2. Waist circumference 3. Achievement of dietary composition targets (<30% energy from fat [<10% energy from saturated fat], 15 g / 1000 kcal fibre), if sufficient food diary data returned
Completion date	20/02/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	150
Key inclusion criteria	Inclusion criteria amended as of 12/10/2007: 1. Patients with a recorded BMI of 28 or more in the last 10 years 2. Age of 18 or more 3. Participants must be able to engage in at least moderate physical activity (e.g. no significant joint problems) 4. Participation will be restricted to those speaking English fluently, as the intervention is based on communication, and many of the measures are specifically validated for English speakers Inclusion criteria provided at time of registration: Identification of potential participants will be by computer searching of GP practice databases by NHS staff employed at the practice (e.g. practice nurse, clerical staff). This will generate a list of patients with a recorded BMI of 30 or more in the last 10 years, and age of 30 or more. A random selection of 420 patients will be identified by applying random numbers generated by the principal researcher. This list will be checked by the patient's GP for exclusion criteria. Participants must also be able to engage in at least moderate physical activity (e.g. no significant joint problems). Participation will be restricted to those speaking English fluently, as the intervention is based on communication, and many of the measures are specifically validated for English speakers. For pragmatic reasons it is not possible to pay for interpreters for this study, although this would be considered for a larger trial.
Key exclusion criteria	Existing diabetes or heart disease, or any other reason the GP thinks the patient is not suitable for the intervention (e.g. severe uncontrolled hypertension, dementia or mental illness preventing likely understanding of the intervention or of the research processes).
Date of first enrolment	30/11/2005
Date of final enrolment	20/02/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Royal Devon & Exeter Hospital (Wonford)

Exeter
EX2 5DW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan