Secondary Prevention of Stroke Through Non-drug Therapeutic Weight Reduction

Study Overview
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Brief Summary
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SCENARIO is a trial to investigate the role of non-drug weight reduction in secondary prevention of stroke. It is a single-blinded, randomized, controlled multicentre trial with two arms. The therapy arm is participating in a comprehensive weight reducing program, whereas the control group takes part in a lecture on healthy nutrition. The primary study objective is to assess the efficacy of non-drug therapeutic weight reduction in the secondary prevention of stroke. Secondary objectives are functional outcome, cognitive status, post stroke depression, and health-related quality of life.

Official Title
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Secondary Prevention of Stroke Through Participation in the Non-drug Therapeutic Weight Reduction Program: A Single-blinded Randomized Controlled Multicenter Trial

Conditions
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Stroke, Obesity

Intervention / Treatment
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* Other: Weight reduction program
* Other: Lecture on healthy nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of ischemic stroke Age: 20 - 85 years BMI ≥ 25.0 kg/m² or waist circumference in men ≥ 94cm and in women ≥ 80cm Functional impairment, which would allow to participate in weight reduction program (mRS 0-4, NIHSS 0-12) Patient must be capable of understanding informed consent Written informed consent for participation in the study Exclusion Criteria: Intracerebral hemorrhage as primary cause of stroke (secondary hemorrhage is not an exclusion criterion) Speech disturbance (aphasia or sever dysarthria) Dimming of consciousness Stroke due to arterial dissection or coagulation disorder Drug-related weight changes during previous 3 months Changes in appetite influencing medication listed in appendix during previous 3 months Bariatric surgery in the past Diabetes mellitus with a history of severe ketoacidosis Pregnancy or nursing Severe co-morbid disorders, e.g.: AV-Block ≥ 2nd degree Heart insufficiency (NYHA > 2) Pericarditis, pericardial effusion Severe kidney insufficiency (Creatinine > 3 mg/dl; Urea > 150 mg/dl) Hepatic insufficiency (GOT > 3 x ULN; GPT > 3 x ULN) Severe psychiatric disease within the last six months (psychosis, suicide attempts) Chronic alcohol addiction or drug addiction HIV- or hepatitis infection Bleeding peptic ulcer (unless there is radiological evidence of healing 6 months prior to start of obesity program) Cognitive impairment with MMSE < 20 Depression with BDI > 20 Patients who are unable to give consent to study participation (MMSE < 20, aphasia) Recurrent stroke or myocardial infarction in the period between screening for study participation and start of weight reduction program Simultaneous participation in another clinical trial

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy arm<br>Non-drug therapeutic weight reduction program (15 weeks) | Other: Weight reduction program<br> <br> |
| Placebo Comparator: Control arm<br>Lecture on healthy nutrition (1 hour) | Other: Lecture on healthy nutrition<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the number of deaths or major vascular events defined as stroke, TIA, myocardial infarction or hospitalization due to angina pectoris, which occur between the randomization and last follow-up. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome | Functional outcome as measured by the modified Rankin Scale (mRS), NIH Stroke Scale (NIHSS) and Barthel Index (BI) | 18 months | 
| Cognitive deficits | Cognitive deficits in terms of vascular dementia as measured by the Structural Interview for diagnosis of Alzheimer dementia and multi-infarct dementia (SIDAM), the Vascular Dementia Assessment Scale cognitive subscale (VADAS-Cog), Stroop test and the Trail Makin Test | 18 months | 
| Post stroke depression | Post stroke depression as measured by Beck Depression Inventar (BDI II) and health-related quality of life (HrQoL) as measured by the EuroQol (EQ5D, visual analogue scale), Stroke Specific Quality of Life Scale, Stroke Impact Scale. | 18 months | 
| Severity of arterial hypertension, diabetes mellitus and hyperlipidemia |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, prevention, obesity, weight reduction