Cardiovascular disease (CVD) Circulatory System Cardiovascular disease, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Being fluent in conversational English 2. Permanent residents and planning to stay in the UK at least ¾ of year. In our local experience of conducting epidemiology and clinical trial studies, 5% of the African, Caribbean and South Asian population are itinerant which increases the risk of attrition, non-completion of the intervention and difficulty of measuring post-randomization factors.
Exclusion criteria
Exclusion criteria: 1. Established cardiovascular (CVD) disease 2. Severe mental illness such as psychosis, learning disability, dementia and cognitive impairment 3. Registered blind 4. Housebound or resident in nursing home 5. Unable to move about independently 6. > 3 falls in past year 7. Pregnancy 8. Advanced cancer 9. Morbid obesity body mass index (BMI) >50 kg/m2 10. Current participation in a weight loss programme. When in doubt we will seek the GP opinion and approval
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in weight (kilograms) and in physical activity (number of timed steps) between arms at 24 months (interim outcome at 12 months). Weight using the Tanita SC240 digital weighing scale and physical activity using the Actigraph GT3X accelerometer at all time points. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Differences in: lipids, blood pressure, HbA1c, and CVD risk and in smoking status at 24 months 2. The EQ-5D will be used to generate quality-adjusted life years 3. Intervention costs will include training and delivering interventions, overheads and other service use will be measured using an adapted Client Service Receipt Inventory. Costs will be calculated by combining service use data with unit costs. | — |
Countries
United Kingdom