The effectiveness of adding a cognitive behavioural therapy aimed at changing lifestyle to an optimal diabetes care system

Not Applicable

Completed

• Conditions: Diabetes Mellitus type II (DM type II); Nutritional, Metabolic, Endocrine; Diabetes mellitus

• Registration Number: ISRCTN12666286
• Lead Sponsor: VU University Medical Centre (The Netherlands)

Brief Summary

2007 Protocol article in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17488511 Study protocol

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-12
• Study Completion: 2006-12-31
• Last Update Posted: 4 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1. Patients with type two diabetes from general practices with the support of a practice nurse
2. Age 40 to 70 years
3. Written informed consent
4. Capable to fill in questionnaires
5. Understanding of Dutch language
6. HbA1c more than 7.0 % and/or Body Mass Index (BMI) more than 27.0 kg/m^2 and/or smoking

Exclusion Criteria

1. Unstable endocrine disorders, with the exception of diabetes
2. Malignant disease
3. Treatment with corticosteroids
4. Serious mental impairment, i.e. preventing to understand the study protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Differences between intervention and usual care groups in changes in diet, physical activity and smoking behaviour according to the ASE-model, a health behaviour model that assumes that behaviour is determined by attitude (A), social influences (S) and self-efficacy (E)<br> 2. Changes in cardiovascular risk score based on the Oxford Risk Engine (algorithm that includes: age at diagnosis, duration of diabetes, sex, ethnicity, smoking status, systolic blood pressure, HbA1c, total cholesterol, HDL-cholesterol). A risk reduction of 5% is clinical relevant.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Quality of life<br> 2. Patient satisfaction<br> 3. Changes in medication use, adherence to prescribed medication<br> 4. Proportion of patients reaching treatment targets according to the guidelines of the Dutch College of General practitioners<br> 5. Adherence to the 3-monthly visit to the general practitioner<br>