None listed
Conditions
Interventions
The three treatment conditions in this study are:
a)Standard care condition by an internist, including:
- individualized diet instructions by a dietician, individualized self-injection and blood glu
1998). Most relevant health goals related to weight reduction are eating healthily and exercise.
One week after the motivational interview, patients will be sent a brief summary of their stated goals
Sponsors
-
Eligibility
Inclusion criteria
Inclusion criteria: Diabetes type II according to WHO classification (1999): fasting blood glucose levels > 126 mg/dl (7mmol/l) or levels > 200 mg/dl (11.1 mmol/l) two hours after an oral glucose tolerance test, treated by an internist from the Máxima Medical Centre, BMI 27-45, between 21 and 70 years old, Caucasian patients who are able to understand, read and write in Dutch.
Exclusion criteria
Exclusion criteria: Patients with any severe co morbidity (except for cardiovascular diseases) will be excluded. Patients who are currently under treatment for a psychological or psychiatric disorder will also be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The main (biomedical) outcome measure in this intervention is GlyHb; 2. The main behavioural outcome measure in this intervention is weight in kilograms. This will be measured at baseline and throughout the intervention in both the intervention and the standard care groups; 3. Dietary and exercise behaviour will be assessed throughout the intervention by means of a short diary procedure. Patients will be asked to shortly write down their nutrition and exercise behaviour from the past week; 4. Psychological outcome measures refer to various psychological factors that may facilitate or inhibit progress toward the weight reduction goals (see also secondary outcome). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Diabetes Quality of Life Measure (DQOL) Patients’ quality of life is measured by the subscale ‘impact’ (20 items) of the validated 46-item Diabetes Quality of Life Measure (DQOL, DCGT Research Group, 1987). 2. The DQOL ‘impact’ scale measures the impact of diabetes treatment and disease management on daily life on a 5-point Likert scale (never-all the time). 3. Problem Areas in Diabetes (PAID). 4. Psychological distress is measured by the validated 20-item Problems Areas in Diabetes (PAID, Polonsky et. al., 1995). 5. The PAID is a brief instrument to assess diabetes-specific distress on a 5-point Likert scale (no problem at all – a very serious problem). 6. Diabetes Management Self-Efficacy Scale (DMSES). 7. Diabetes related self-efficacy will be measured by the validated Diabetes Management Self-Efficacy Scale (DMSES, Sturt & Hearnshaw, 2003). The DMSES contains of 20 items on a 10-point Likert scale (absolutely not able – I’m totally able). 8. Positive and Negative Affectivity Scale (PANAS). 9. Patients’ negative and positive affect will be measured by the validated 20-item Positive and Negative Affectivity Scale (PANAS, Watson, Clark & Tellegen, 1988). The PANAS consists of 20 mood related words for which patients can indicate on a 5-point scale (not at all applicable – very applicable) to what extent the word is applicable to their mood over the past two weeks. 10. Beck Depression Inventory II (BDI-II) Depressive thoughts and feelings will be measured by the validated 20 item Beck Depression Inventory II (BDI-II, Beck, 1987). De BDI-II consists of 21 multiple choice questions of how patients felt within the past two weeks. Nineteen questions have 4 multiple choice options, two questions have 7 multiple choice options. 11. Self-Regulation Skills Scale and GAPI Patients’ self-regulation skills and goal processes will be measured by the 15- and 45-item Self-Regulation Skills Scale (Maes & de Gucht, 2004) and five subscales (26 items) of the valid | — |
Contacts
Public ContactSasja Huisman
Leiden University Medical Center (LUMC), Department of Psychology, P.O. 9555
Outcome results
None listed