Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
14/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Corina van den Hurk

ORCID ID

Contact details

Zernikestraat 29
Eindhoven
5612 HZ
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

Approved by the Medical Ethical Committee of the VU University Medical Center Amsterdam.

Study design

Randomised, active controlled, factorial, single blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/09/2005

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

300

Participant 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

Recruitment start date

01/09/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Zernikestraat 29
Eindhoven
5612 HZ
Netherlands

Sponsor information

Organisation

VU University Medical Centre (The Netherlands)

Sponsor details

EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8180
emgo@vumc.nl

Sponsor type

University/education

Website

http://www.emgo.nl/

Funders

Funder type

Research council

Funder name

EMGO Institute (The Netherlands) - internal funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Study protocol

    Welschen LM, van Oppen P, Dekker JM, Bouter LM, Stalman WA, Nijpels G, The effectiveness of adding cognitive behavioural therapy aimed at changing lifestyle to managed diabetes care for patients with type 2 diabetes: design of a randomised controlled trial., BMC Public Health, 2007, 7, 74, doi: 10.1186/1471-2458-7-74.

Additional files

Editorial Notes