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Cost-effectiveness of a tailored lifestyle intervention in patients with serious mental illness: the SMILE-study

Cost-effectiveness of a tailored lifestyle intervention in patients with serious mental illness: the SMILE-study - SMILE (Serious Mental Illness Lifestyle Evaluation)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47451
Enrollment
260
Registered
2017-10-26
Start date
2018-01-22
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Serious Mental Illness, Obesity, cardiovascular disease. mental health disorder Mental illness

Interventions

A tailored lifestyle intervention aiming at a healthy diet, increased physical activity.

Sponsors

Vrije Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with serious mental illness Age *18 years old Body mass index *27 Willing to and able to sign informed consent (mentally competent)

Exclusion criteria

Exclusion criteria: *Contra-indications (to be assessed by the treating physician/psychiatrist) for participation due to acute psychiatric crisis or somatic diseases (e.g. bariatric surgery, cancer, heart attack or stroke) *Subjects with a cognitive impairment sufficient to interfere with their ability to provide informed consent, complete study questionnaires, or participate in a group intervention *Women who are pregnant, breastfeeding, or planning a pregnancy during the course of the study *Subjects not able to communicate in the Dutch language

Design outcomes

Primary

MeasureTime frame
Weight loss (kg).

Secondary

MeasureTime frame
Central obesity, lipids (LDL, HDL and total cholesterol, triglycerides), diastolic and systolic blood pressure, glucose metabolism, quality of life, self-management of one*s health or chronic condition and societal costs after 1 year follow-up.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)