Health Promotion and Wellness Program for Stroke Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by The Cleveland Clinic
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Matthew Plow, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01776034
First received: January 23, 2013
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

The objective of this study is to conduct a randomized controlled pilot study to examine the efficacy, feasibility and safety of the SystemCHANGE™ health promotion and wellness program in stroke survivors. The central hypothesis of the study is that the SystemCHANGE™ program will help overweight and obese stroke survivors engaging in healthy behaviors, thereby improving health and function.


Condition Intervention Phase
Stroke
Behavioral: SystemCHANGE Group Lifestyle counseling
Behavioral: Phone Lifestyle Counseling
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Examining the Efficacy of a SystemCHANGE™ Weight Management Intervention in Stroke Survivors

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Changes from baseline in body weight and percent body fat [ Time Frame: Each patient will be given the assessments at 3 points during the study, at baseline, interim test (an average of 3 months from baseline) and at posttest (an average of 6 months from baseline). ] [ Designated as safety issue: Yes ]
    body weight and percent body fat will be measured with the Bod Pod

  • Changes from baseline in patient-reported quality of life [ Time Frame: Each patient will be given the assessments at 3 points during the study, at baseline, interim test (an average of 3 months from baseline) and at posttest (an average of 6 months from baseline). ] [ Designated as safety issue: No ]
    Stroke Impact Scale and Reintegration to Normal Living Index will be administered.

  • Changes from baseline in physical function [ Time Frame: Each patient will be given the assessments at 3 points during the study, at baseline, interim test (an average of 3 months from baseline) and at posttest (an average of 6 months from baseline). ] [ Designated as safety issue: No ]
    6-Minute Walking Test and Rivermead Motor Assessment will be conducted.


Secondary Outcome Measures:
  • Changes from baseline in biomarkers. [ Time Frame: Each patient will be given the assessments at 3 points during the study, at baseline, interim test (an average of 3 months from baseline) and at posttest (an average of 6 months from baseline). ] [ Designated as safety issue: No ]
    Blood draws will be performed for cholesterol, triglycerides, C-reactive protein, and hemoglobin A1c.

  • Changes from baseline in healthy behaviors and psychosocial mediators [ Time Frame: Each patient will be given the assessments at 3 points during the study, at baseline, interim test (an average of 3 months from baseline) and at posttest (an average of 6 months from baseline). ] [ Designated as safety issue: No ]
    A three-day food diary, the Physical Activity and Disability Survey, and sleep quality measured with the Patient-Reported Outcomes Measurement Information System (PROMIS)will be administered. Potential psychosocial mediators that will be measured include self-efficacy for diet, physical activity, and self-management, and social support for healthy behaviors.


Estimated Enrollment: 45
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SystemCHANGE Group Lifestyle counseling
The SystemCHANGE™ intervention will be delivered over a six-month period involving 12 face-to-face group sessions (1.5 hours each) held weekly for three months, followed by three monthly "booster calls." Intervention groups include up to 10 patients, and family is encouraged to attend. Intervention sessions consist of 30-min of behavior change activities and 60-min focused on healthy behaviors.
Behavioral: SystemCHANGE Group Lifestyle counseling
Active Comparator: Phone Lifestyle Counseling
Participants will receive pamphlets that contain information on healthy eating, physical activity, sleep, and symptom management, and will be followed-up with telephone calls.
Behavioral: Phone Lifestyle Counseling

Detailed Description:

Over 60% of stroke survivors are either overweight or obese, and a projected 4.98 million stroke survivors have multiple cardiovascular risk factors. Stroke survivors are at significant risk for de-conditioning, elevated inflammatory markers, and insulin resistance, which subsequently increases risk for secondary stroke and cardiovascular disease. Engaging in healthy behaviors, such as physical activity, good sleep hygiene, and nutrition, to facilitate energy balance may help reduce the risk of secondary conditions and ultimately improve physical function and quality of life in stroke survivors. Thus, the specific study aims are to engage potential participants (i.e., stroke survivors) and their families as co-designers to adapt the SystemCHANGE™ comprehensive lifestyle intervention, and then conduct a randomized controlled pilot study to provide preliminary estimates of the intervention's efficacy in 35 stroke survivors.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • physician-confirmed unilateral ischemic or hemorrhagic stroke
  • at least 6 weeks post-stroke
  • physician consent to participate
  • BMI between 25 to 40 kg/m2
  • stable weight for the past 4 weeks

Exclusion Criteria:

  • heart disease (i.e., myocardial infarction, congestive heart failure, coronary artery bypass grafting or valve replacement during the past 3 months, serious cardiac arrhythmias, hypertrophic cardiomyopathy, and severe aortic stenosis)
  • pulmonary embolus,
  • uncontrolled blood pressure (i.e., 140/90 mmHg) or diabetes (fasting blood sugar levels > 125 mg/dl)
  • unable to communicate
  • severe cognitive deficits
  • pregnancy
  • three or more falls in the past month,
  • inability to walk 3 meters with or without a mobility device,
  • weight loss medications or medications that cause weight gain (i.e., corticosteroids and antipsychotic),
  • gastric bypass surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776034

Contacts
Contact: Corey McDaniel, BA (216) 445-9674 mcdanic3@ccf.org
Contact: Mark Mcglynn, MS (216)445-1203 mcglynm2@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Corey McDaniel, BA    216-445-9674    mcdanic3@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
American Heart Association
Investigators
Principal Investigator: Matthew A Plow, PhD The Cleveland Clinic
  More Information

No publications provided by The Cleveland Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matthew Plow, Project Scientist, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01776034     History of Changes
Other Study ID Numbers: 11-847
Study First Received: January 23, 2013
Last Updated: August 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Self Care
Exercise
Weight management

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 28, 2014