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 |
| Protocol serial number | G0501280 |
| Sponsor | University of Manchester (UK) |
| Funder | The Medical Research Council (MRC): The National Prevention Research Initiative (NPRI) (UK) |
- Submission date
- 29/01/2007
- Registration date
- 11/05/2007
- Last edited
- 28/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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 Roger Harrison
Scientific
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 |
|---|---|
| roger.harrison@manchester.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Feasibility study for a two-group randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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(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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 17/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 18+ years old with one or more diagnoses of: 1. Hypertension 2. Raised total cholesterol 3. Diabetes 4. Obesity 5. Smoker |
| Key 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 |
| Date of first enrolment | 18/09/2006 |
| Date of final enrolment | 17/09/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Manchester
Manchester
M13 9PT
United Kingdom
M13 9PT
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/01/2016: no publications found on PubMed.
28/02/2018: no publications found, verifying study status with principal investigator.
