Exploring the ability of lay workers to support heart-health related behaviour change in deprived areas through Heart of Mersey

ISRCTN	ISRCTN54763837
DOI	https://doi.org/10.1186/ISRCTN54763837
Secondary identifying numbers	G0501280

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Dr Roger Harrison
Scientific

Division of Epidemiology & Health Sciences
The Medical School
University of Manchester
Oxford Road
Manchester
M13 9PT
United Kingdom

Phone	+44 (0)161 275 5200
Email	roger.harrison@manchester.ac.uk

Study design	Feasibility study for a two-group randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Exploring the ability of lay workers to support heart-health related behaviour change in deprived areas through Heart of Mersey
Study acronym	LhtIST (Lay health trainer Intervention STudy)
Study hypothesis	To examine the feasibility of a Randomised Controlled Trial (RCT) to assess lay health worker intervention to reduce Coronary Heart Disease (CHD) risk using lifestyle/behaviour change.
Ethics approval(s)	Ethics approval MREC ref: 07/H1002/65
Condition	Cardiovascular disease
Intervention	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.
Intervention type	Behavioural
Primary outcome measure	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 measures	Not provided at time of registration
Overall study start date	18/09/2006
Overall study end date	17/09/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	100 for this feasibility study
Participant inclusion criteria	18+ years old with one or more diagnoses of: 1. Hypertension 2. Raised total cholesterol 3. Diabetes 4. Obesity 5. Smoker
Participant 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
Recruitment start date	18/09/2006
Recruitment end date	17/09/2008

University of Manchester

Manchester
M13 9PT
United Kingdom

University of Manchester (UK)
University/education

c/o Ms Karen Shaw
Research Office, 2nd floor
Christie Building
University of Manchester
Manchester
M13 9PT
England
United Kingdom

Government

The Medical Research Council (MRC): The National Prevention Research Initiative (NPRI) (UK)

No information available

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

18/01/2016: no publications found on PubMed.
28/02/2018: no publications found, verifying study status with principal investigator.