Primary Objective: To reduce weight after in persons with SMI in outpatient psychiatric treatment settings who are treated by Flexible Assertive Community Treatment teams (FACT-teams) after 1 year.Secondary Objective(s): To reduce cardiovascular…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Serious Mental Illness, Obesity, cardiovascular disease.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Weight loss (kg).
Secondary outcome
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.
Background summary
Cardiovascular disease is one of the leading causes of the estimated 20-25
years reduced life expectancy for persons with serious mental illness (SMI).
This excess cardiovascular mortality is primarily attributable to obesity,
diabetes, hypertension, dyslipidemia and lifestyle factors (6). Additionally,
cardiovascular disease in persons with SMI contributes to enormous societal
costs. The reduction of these cardiovascular risks have been associated with
perfoming lifestyle interventions. However, evidence concerning the
costs-effectiveness of lifestyle interventions in outpatient psychiatric
treatment settings is lacking.
Study objective
Primary Objective: To reduce weight after in persons with SMI in outpatient
psychiatric treatment settings who are treated by Flexible Assertive Community
Treatment teams (FACT-teams) after 1 year.
Secondary Objective(s): To reduce cardiovascular risks (central obesity,
lipids, blood pressure, glucose), improve quality of life, and reduce health
care costs in persons with SMI in outpatient psychiatric treatment settings who
are treated by FACT-teams after 1 year.
Study design
To evaluate the cost-effectiveness of a tailored lifestyle intervention in
persons with serious mental illness (SMI) in outpatient psychiatric treatment
settings in comparison to usual care.
Intervention
A tailored lifestyle intervention aiming at a healthy diet, increased physical
activity.
Study burden and risks
Risks associated with participation in this study are deemed minor. Possible
extra risk which is associated with the intervention includes injury as a
result of indoor or outdoor physical activity. However, as the primary physical
activity is walking outdoors, this is considered a minor risk. Apart from that,
risks involving venapuncture (such as minor bruising, hematoma, bleeding
complications, fainting or infections) could occur. However patients involved
in the study have annual laboratory check-ups. The laboratory assessments are
measured at baseline and after 12 months, this study will make use of the
patient*s annual (from the annual somatic screening) check-ups whenever
possible in order to avoid extra visits to the laboratory.
De Boelelaan 1085
Amsterdam 1081HV
NL
De Boelelaan 1085
Amsterdam 1081HV
NL
Listed location countries
Age
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
*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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL60315.029.17 |
| OMON | NL-OMON20617 |