Diabetes and heart disease Nutritional, Metabolic, Endocrine Diabetes and heart disease
Conditions
Interventions
Please note that the amendments to the target number of participants and participants - inclusion criteria (both amended as of 12/10/2007) reflect errors in information provided at time of registratio
Sponsors
Devon Primary Care Trust (UK)
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria amended as of 12/10/2007: 1. Patients with a recorded BMI of 28 or more in the last 10 years 2. Age of 18 or more 3. Participants must be able to engage in at least moderate physical activity (e.g. no significant joint problems) 4. Participation will be restricted to those speaking English fluently, as the intervention is based on communication, and many of the measures are specifically validated for English speakers Inclusion criteria provided at time of registration: Identification of potential participants will be by computer searching of GP practice databases by NHS staff employed at the practice (e.g. practice nurse, clerical staff). This will generate a list of patients with a recorded BMI of 30 or more in the last 10 years, and age of 30 or more. A random selection of 420 patients will be identified by applying random numbers generated by the principal researcher. This list will be checked by the patient's GP for exclusion criteria. Participants must also be able to engage in at least moderate physical activity (e.g. no significant joint problems). Participation will be restricted to those speaking English fluently, as the intervention is based on communication, and many of the measures are specifically validated for English speakers. For pragmatic reasons it is not possible to pay for interpreters for this study, although this would be considered for a larger trial.
Exclusion criteria
Exclusion criteria: Existing diabetes or heart disease, or any other reason the GP thinks the patient is not suitable for the intervention (e.g. severe uncontrolled hypertension, dementia or mental illness preventing likely understanding of the intervention or of the research processes).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of people achieving specific targets for weight change and physical activity which have been shown to be beneficial in previous studies. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures added as of 16/07/2007: 1. The proportion of participants achieving 150 min moderate activity per week 2. Waist circumference 3. Achievement of dietary composition targets (<30% energy from fat [<10% energy from saturated fat], 15 g / 1000 kcal fibre), if sufficient food diary data returned | — |
Countries
United Kingdom
Outcome results
None listed