Lifestyle Interventions for Severe Mentally Ill Outpatients in the Netherlands.

Lifestyle Interventions for Severe Mentally Ill Outpatients in the Netherlands. - LION

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38658

Enrollment

768

Registered

2013-12-20

Start date

2014-01-06

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

The 12-month intervention consists of biweekly 15-minute sessions. The self-management tool is based on e-health and is developed as the Traffic Light website (www.leefstijlinbeeld.nl). It is develo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Exclusion criteria: - pregnancy; - BMI

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is waist circumference.	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)