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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 26 March 2018
Main ID:  ISRCTN54763837
Date of registration: 11/05/2007
Prospective Registration: No
Primary sponsor: University of Manchester (UK)
Public title: Exploring the ability of lay workers to support heart-health related behaviour change in deprived areas through Heart of Mersey
Scientific title: Exploring the ability of lay workers to support heart-health related behaviour change in deprived areas through Heart of Mersey
Date of first enrolment: 18/09/2006
Target sample size: 100
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN54763837
Study type:  Interventional
Study design:  Feasibility study for a two-group randomised controlled trial (Prevention)  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Roger    Harrison
Address:  Division of Epidemiology & Health Sciences The Medical School University of Manchester Oxford Road M13 9PT Manchester United Kingdom
Telephone: +44 (0)161 275 5200
Email: roger.harrison@manchester.ac.uk
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 18+ years old with one or more diagnoses of:
1. Hypertension
2. Raised total cholesterol
3. Diabetes
4. Obesity
5. Smoker

Exclusion criteria: 1. Established CHD
2. Non consenting
3. On current diet conflicting with heart-health dietary guidelines
4. Homeless/hostel/residential/nursing home residents
5. Life-expectancy <2 years
6. Physical/mental health reasons


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Cardiovascular disease
Circulatory System
Intervention(s)
Lay worker support delivered in the home and links to existing community initiatives to promote heart-health diet, physical activity, sensible drinking and smoking cessation.
Primary Outcome(s)
A feasibility study for a RCT, to examine recruitment strategies, outcome measures, and delivery methods of the intervention. Aim of the main trial will be to reduce CHD risk factors.
Secondary Outcome(s)
Not provided at time of registration
Secondary ID(s)
G0501280
Source(s) of Monetary Support
The Medical Research Council (MRC): The National Prevention Research Initiative (NPRI) (UK)
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Ethics approval MREC ref: 07/H1002/65
Results
Results available: Yes
Date Posted:
Date Completed: 17/09/2008
URL:
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