ID
Source
Brief title
Health condition
Obesitas, cardiovasculaire aandoeningen en ernstige psychiatrische problematiek.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Weight (kg)
Secondary outcome
cardiovascular risks (central obesity, lipids, blood pressure, glucose metabolism), quality of life, health related self-efficacy and societal costs.
Background summary
Cardiovascular disease is the leading cause of the estimated 20-25 years reduced life expectancy for persons with serious mental illness. This excess cardiovascular mortality is primarily attributable to obesity, diabetes, hypertension, and dyslipidemia. Obesity in particular has been associated with a sedentary lifestyle, limited physical activity and an unhealthy diet in persons with serious mental illness. Evidence concerning the costs-effectiveness of lifestyle interventions in outpatient psychiatric treatment settings is lacking. Therefore, this study to evaluates the cost-effectiveness of a lifestyle intervention in persons with serious mental illness in outpatient psychiatric treatment settings in comparison to usual care. The study will consist of an economic evaluation alongside a cluster randomized controlled trial.
The lifestyle intervention aims at a healthy diet and increased physical activity and consists of group sessions including personal action plans and makes use of elements of motivational interviewing and goal setting. Main study parameters/endpoints include: weight loss (primary outcome), cardiovascular risks (central obesity, lipids, blood pressure, glucose metabolism), quality of life, health related self-efficacy and societal costs after 1 year follow-up.
Study design
Baseline, 3 months, 6 months and 12 months
Intervention
Lifestyle intervention consisting of group sessions focussing on nutrition and fysical activity
Inclusion criteria
patient with SMI
age ≥18
body mass index ≥27
willing to and able to sign informed consent (mentally competent)
Exclusion criteria
Contra-indications 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
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6660 |
| NTR-old | NTR6837 |
| Other | METc (VUmc) // ZonMw : 2017.418 // 80-84300-98-72012 |
| CCMO | NL60315.029.17 |
| OMON | NL-OMON47451 |