NCT01721538

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

November 5, 2012

Status Verified

November 1, 2012

Enrollment Period

2.5 years

First QC Date

November 1, 2012

Last Update Submit

November 2, 2012

Conditions

StrokeObesity

Keywords

strokepreventionobesityweight reduction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Functional outcome

    18 months

  • Cognitive deficits

    18 months

  • Post stroke depression

    18 months

  • Severity of arterial hypertension, diabetes mellitus and hyperlipidemia

    18 months

Study Arms (2)

Therapy arm

EXPERIMENTAL

Non-drug therapeutic weight reduction program (15 weeks)

Other: Weight reduction program

Control arm

PLACEBO COMPARATOR

Lecture on healthy nutrition (1 hour)

Other: Lecture on healthy nutrition

Interventions

Weight reduction programOTHER
Therapy arm
Lecture on healthy nutritionOTHER
Control arm

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Philipps-University Marburg

Marburg, Germany

RECRUITING

Related Publications (1)

  • Winter Y, Rohrmann S, Linseisen J, Lanczik O, Ringleb PA, Hebebrand J, Back T. Contribution of obesity and abdominal fat mass to risk of stroke and transient ischemic attacks. Stroke. 2008 Dec;39(12):3145-51. doi: 10.1161/STROKEAHA.108.523001. Epub 2008 Aug 14.

    PMID: 18703800BACKGROUND

MeSH Terms

Conditions

StrokeObesityWeight Loss

Interventions

Weight Reduction Programs

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Health PromotionHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Yaroslav Winter, MD

CONTACT

00496421-5865200wintery@med.uni-marburg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurologist and Research Fellow

Study Record Dates

First Submitted

November 1, 2012

First Posted

November 5, 2012

Study Start

October 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

November 5, 2012

Record last verified: 2012-11

Locations

DE(1)