ifestyle Interventions for Severe Mentally Ill Outpatients in the Netherlands.

Completed

Conditions: overgewicht, hypertensie
diabetes type 2 and cardiovascular disease)
overweight and cardiometabolic risk (increased risk of hypertension
10018424
10024450

Registration Number: NL-OMON38658

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 768

Inclusion Criteria

Included patients have at least one of the following risk factors:
- waist circumference > 102 cm (male) or > 88 cm (female);
- fasting glucose > 5.6 mmol/l; or HbA1c > 5.7 %
- BMI > 25 kg/m2.
- patient participates in yearly ROM-screening (routine screening for somatic and mental health)

Exclusion Criteria

- pregnancy;
- BMI < 19 kg/m2
- physical impairments that make daily physical activity impossible
- patients with primary diagnosis of Korsakov syndrome

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is waist circumference. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include obesity/cardiometabolic risk (BMI, blood pressure,<br /><br>plasma triglycerides, cholesterol (LDL, HDL, and total cholesterol), fasting<br /><br>glucose and HbA1c), psychological outcomes (depressive symptoms, negative<br /><br>symptoms), outcomes for cost-effectiveness (quality of life, care consumption,<br /><br>registration of medication) and behavioural/environmental determinants of<br /><br>intervention success in both patients and nurses (like readiness to change,<br /><br>attitude). The somatic measurements including lab tests and most questionnaires<br /><br>are part of standard Routine Outcome Monitoring. Other information is collected<br /><br>using questionnaires. Measurements are taken at baseline, after 6 and after 12<br /><br>months. For intervention participants, a small somatic assessment (BMI, waist<br /><br>cirucmference, blood pressure) is taken at 3 and 9 months to provide feedback<br /><br>on lifestyle changes. </p><br>