Skip to content

Comparing the effectiveness of enhanced motivational interviewing with usual care for reducing cardiovascular risk

A multi-centre randomised controlled trial comparing the effectiveness of enhanced motivational interviewing with usual care for reducing cardiovascular risk

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN84864870
Enrollment
1700
Registered
2012-05-15
Start date
2012-08-01
Completion date
Unknown
Last updated
2020-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease (CVD) Circulatory System Cardiovascular disease, unspecified

Interventions

The intervention will be based on the Theory of Planned Behaviour (TPB) for initiation of behaviour change. The TPB states that in order to change behaviour, people need to form an intention. Intentio
evocation (as opposed to didactic reasoning) and patient autonomy (as opposed to authoritative style) The key skills in MI are the ability to express empathy (which includes understan

Sponsors

King's College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 17, 2026