Secondary Prevention of Stroke Through Non-drug Therapeutic Weight Reduction (SCENARIO)

Philipps University

Status: Unknown

Conditions: Stroke; Obesity

Treatments: Other: Lecture on healthy nutrition; Other: Weight reduction program

Study type: Interventional

Funder types: Other

Identifiers

NCT01721538

SCENARIO OP1

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups, including a placebo group

Therapy arm

Experimental group

Description:

Non-drug therapeutic weight reduction program (15 weeks)

Treatment:

Other: Weight reduction program

Control arm

Placebo Comparator group

Description:

Lecture on healthy nutrition (1 hour)

Treatment:

Other: Lecture on healthy nutrition