A self regulatory weight reduction intervention in diabetes type II patients

Completed

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

Registration Number: ISRCTN05538040

Lead Sponsor: Máxima Medical Center (The Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 270

Inclusion Criteria

1. Diabetes type II according to World Health Organization (WHO) classification (1999): fasting blood glucose levels greater than 126 mg/dl (7 mmol/l) or levels greater than 200 mg/dl (11.1 mmol/l) two hours after an oral glucose tolerance test
2. Treated by an internist from the Máxima Medical Centre
3. Body mass index (BMI) 27 - 45 kg/m^2
4. Between 21 and 70 years old
5. Caucasian patients who are able to understand, read and write in Dutch

Exclusion Criteria

1. Patients with any severe co morbidity (except for cardiovascular diseases) will be excluded
2. Patients who are currently under treatment for a psychological or psychiatric disorder will also be excluded from the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The main (biomedical) outcome measure in this intervention is GlyHb<br>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.<br>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. <br>4. Psychological outcome measures refer to various psychological factors that may facilitate or inhibit progress toward the weight reduction goals (see also secondary outcomes)

Secondary Outcome Measures