Cardiovascular disease Circulatory System Cardiovascular disease, unspecified
Conditions
Interventions
The sample size is calculated to provide realistic estimates (and confidence intervals (CIs)) for the recruitment and study completion rates. The resulting sample size will also allow realistic estima
Sponsors
Bath and North East Somerset Primary Care Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 40-74 2. BMI 30 or more (27.5 for S. Asians, if ethnicity is known) 3. A ten year cardiovascular risk score of 20% or more (calculated using either the Framingham or QRISK method) 4. IGT - Impaired glucose tolerance (2 hour glucose on IGT test of 7.8 to 11.0 mmol/l) 5. IFG - Impaired fasting plasma glucose (6.1 to 6.9mmol/l.) 6. Male and female participants If recruitment proves difficult using the above criteria, we will search practice databases for people with higher risk obesity, defined as having a Body Mass Index of 30 or more plus either hypertension, hypercholesterolemia, family history of diabetes or heart disease, history of gestational diabetes, or polycystic ovary syndrome.
Exclusion criteria
Exclusion criteria: 1. People with existing heart disease or type 2 diabetes 2. People who are currently pregnant 3. People currently using weight loss drugs (which will interfere with planned measures) 4. People not fluent in English 5. Anyone who, in their GP?s opinion, has other conditions that would prevent engagement with the programme (including terminal illness, major mental health problems, communication difficulties requiring translation)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment rate measured at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All measures proposed for the main trial (e.g. weight) will be taken and variance explored at 0, 4, and 12 months 2. Intervention concordance (the proportion attending >=4 of the 7 sessions) measured at 8 months 3. Study completion rate measure at 12 months | — |
Countries
United Kingdom
Outcome results
None listed