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Serious Mental Illnes Lifestyle Evaluation


- candidate number28214
- NTR NumberNTR6837
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-nov-2017
- Secondary IDs2017.418 // 80-84300-98-72012 METc (VUmc) // ZonMw
- Public TitleSerious Mental Illnes Lifestyle Evaluation
- Scientific TitleSerious Mental Illnes Lifestyle Evaluation
- ACRONYMSMILE
- hypothesis
- Healt Condition(s) or Problem(s) studiedObesity, Cardiovascular disease, Psychiatric patients
- Inclusion criteriapatient with SMI
age ≥18
body mass index ≥27
willing to and able to sign informed consent (mentally competent)
- Exclusion criteriaContra-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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2018
- planned closingdate1-feb-2020
- Target number of participants260
- InterventionsLifestyle intervention consisting of group sessions focussing on nutrition and fysical activity
- Primary outcomeWeight (kg)
- Secondary outcomecardiovascular risks (central obesity, lipids, blood pressure, glucose metabolism), quality of life, health related self-efficacy and societal costs.
- TimepointsBaseline, 3 months, 6 months and 12 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Marcel Adriaanse
- CONTACT for SCIENTIFIC QUERIES Florine Walburg
- Sponsor/Initiator Vrije Universiteit Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summaryCardiovascular 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.
- Main changes (audit trail)
- RECORD16-nov-2017 - 10-dec-2017


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