The effectiveness of adding a cognitive behavioural therapy aimed at changing lifestyle to an optimal diabetes care system
| ISRCTN | ISRCTN12666286 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12666286 |
| Secondary identifying numbers | NL68 (NTR92) |
- Submission date
- 12/09/2005
- Registration date
- 12/09/2005
- Last edited
- 23/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Corina van den Hurk
Scientific
Scientific
Zernikestraat 29
Eindhoven
5612 HZ
Netherlands
Study information
| Study design | Randomised, active controlled, factorial, single blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | The effectiveness of adding a cognitive behavioural therapy aimed at changing lifestyle to an optimal diabetes care system |
| Study objectives | A cognitive behaviour intervention is more effective in achieving behavioural changes and therefore changes in lifestyle and cardiovascular risk profile than usual care in patients with type two diabetes. |
| Ethics approval(s) | Approved by the Medical Ethical Committee of the VU University Medical Center Amsterdam. |
| Health condition(s) or problem(s) studied | Diabetes Mellitus type II (DM type II) |
| Intervention | Intervention group: A Cognitive Behavioural Therapy (CBT) which consist of a Motivational Interviewing phase and a Problem Solving Treatment phase. The CBT will be performed by dieticians and diabetes nurses and includes six individual sessions of 30 minutes. This sessions will be performed within a period of 16 weeks. Usual care group: Usual care by general practitioner/practice nurse and an annual check-up Diabetes Research Centre as is usual in the optimal care system where the study will be performed. Both groups will be measured at baseline, at six and at 12 months. Measurements include: demographic patient characteristics, patients' history, diabetes care, clinical patients' characteristics (weight, height, waist circumference, foot inspection, blood pressure, fasting plasma glucose, HbA1c, total cholesterol, High Density Lipoprotein [HDL]-cholesterol) and questionnaires. |
| Intervention type | Other |
| Primary outcome measure | 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) 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. |
| Secondary outcome measures | 1. Quality of life 2. Patient satisfaction 3. Changes in medication use, adherence to prescribed medication 4. Proportion of patients reaching treatment targets according to the guidelines of the Dutch College of General practitioners 5. Adherence to the 3-monthly visit to the general practitioner |
| Overall study start date | 01/09/2005 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 300 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Zernikestraat 29
Eindhoven
5612 HZ
Netherlands
5612 HZ
Netherlands
Sponsor information
VU University Medical Centre (The Netherlands)
University/education
University/education
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 444 8180 |
|---|---|
| emgo@vumc.nl | |
| Website | http://www.emgo.nl/ |
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Research council
EMGO Institute (The Netherlands) - internal funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Study protocol | 08/05/2007 | Yes | No |
Editorial Notes
23/09/2021: Proactive update review. No publications found. Search options exhausted.
