ifestyle change in individuals at risk of diabetes and heart disease

Completed

• Conditions: Diabetes and heart disease; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN77825185
• Lead Sponsor: Devon Primary Care Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-29
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified