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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Weight reduction program Other
    ARM 1: Kind: Experimental
    Label: Therapy arm
    Description: Non-drug therapeutic weight reduction program (15 weeks)
  • Lecture on healthy nutrition Other
    ARM 1: Kind: Experimental
    Label: Control arm
    Description: Lecture on healthy nutrition (1 hour)

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Investigator)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 No
Secondary Functional outcome 18 months No
Secondary Cognitive deficits 18 months No
Secondary Post stroke depression 18 months No
Secondary Severity of arterial hypertension, diabetes mellitus and hyperlipidemia 18 months No

Sponsors