Stroke Health and Risk Education (SHARE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Diocese of Corpus Christi, Texas, USA
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01378780
First received: June 15, 2011
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

Stroke is a disease with tremendous individual, family, and societal impact. It is the number one cause of adult disability and third leading cause of death in the United States. Between now and the year 2050, the cost of stroke in the United States will exceed 2 trillion dollars. There is a tremendous ethnic disparity with respect to stroke in the United States. Mexican Americans are much more likely to have a stroke compared with European Americans. In Mexican Americans strokes occur at younger ages, are more likely to recur and have the same severity as they do in European Americans. Mexican Americans are the overwhelming largest sub-population of Hispanic Americans, the nation's largest minority group. This proposal, a scientifically-based rigorous behavioral education intervention trial, seeks to aggressively prevent stroke, especially in Mexican Americans.

Faith and family are strong components of Mexican American culture. This project works with these positive fundamental elements in order to affect stroke prevention. This project will take place in Nueces County, Texas. The project investigators have worked in this community for the past 14 years and have published extensively regarding the stroke health disparity in this stable, non-immigrant community of Mexican Americans and European Americans. We have established a strong partnership with the Catholic Diocese of Corpus Christi and assembled a team with tremendous experience at successful health behavior intervention research. Together, a proposal has been crafted that will directly speak to aggressive stroke risk factor reduction in Mexican Americans and European Americans in this representative United States community.

The significance of such research is tremendous. As the Mexican American population grows and ages, the stroke impact will be felt with greater and greater intensity. Now is the time to develop aggressive, scientifically tested interventions to limit the burden of this disease on this important segment of the United States population, and to reduce the costs of this disease to the country as a whole, in keeping with the Government Performance and Results Act (GPRA) goal to "identify culturally appropriate, effective stroke prevention programs for nationwide implementation in minority communities" by FY2010.


Condition Intervention
Stroke
Hypertension
Behavioral: Educational intervention for diet and physical activity
Behavioral: Educational message on skin cancer awareness

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Stroke Health and Risk Education (SHARE)

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Sodium intake [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The primary outcome measures include the three most important behavioral predictors of systolic blood pressure and/or stroke risk: sodium intake, fruit and vegetable intake, and physical activity

  • Fruit/vegetable intake [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Systolic blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    High blood pressure is the number one cause of stroke


Estimated Enrollment: 800
Study Start Date: May 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention for diet, exercise
This group will receive the educational intervention for healthy diet and increased physical activity
Behavioral: Educational intervention for diet and physical activity
The proposed project, SHARE, is a culturally-tailored, primary stroke prevention intervention for MAs and EAs that targets a number of health-related behaviors related to stroke risk. Using a combination of self-help materials, social support, peer counseling based on Motivational interviewing, tailored newsletters, and social environmental changes in Catholic Churches, the SHARE intervention will lead to increases in moderate and vigorous intensity physical activity, decreases in salt intake, and increases in fruit and vegetable intake. Additional targets include decreases in BMI for those overweight or obese, reduction of dietary fat (trans, saturated and total fat), and increases in low-fat dairy products, changes that will serve to reduce blood pressure and stroke risk. Additionally, SHARE will seek to improve hypertension medication adherence in participants with previously diagnosed high blood pressure at baseline screening.
Control
This group will get a skin cancer awareness educational message. At the end of the study this group will also receive the diet and exercise intervention but outcomes will not be measured after the crossover.
Behavioral: Educational message on skin cancer awareness
Control group will get the diet and physical activity intervention after the crossover but no outcomes will be measured after the crossover

Detailed Description:

The study is a randomized, parallel group, behavioral intervention trial designed to reduce stroke risk. The assembled investigative team has outstanding relevant experience in epidemiology, behavioral intervention, health services clinical trials, and medicine. The target populations are Mexican Americans (MA) and European Americans (EA) living in a medium size U.S. city, Corpus Christi, Texas. We have extensive experience conducting research in this community. In fact we have run two highly successful, NIH-funded projects in Corpus Christi. The proposed study is a true partnership of investigators from the University of Michigan, who have worked in this community for 14 years, and the Diocese of Corpus Christi. The primary outcome in this stroke prevention project will include key stroke risk factors: sodium intake, fruit and vegetable intake, and physical activity. Churches have been recruited (100% cooperation rate) and will be randomized to intervention and control groups. A theory-based, scientific, rigorous, behavioral intervention was carefully crafted. In addition to theory and investigators' experience in this community, project development involved a pilot study of risk factor data collection from Church goers, and detailed focus groups from a different group of Church members and clergy.

Specific aim: To test the effectiveness of a culturally-sensitive, church-based, multicomponent, behavioral intervention for Mexican Americans and European Americans in reducing important behavioral and biological stroke risk factors.

Hypothesis 1: Participants randomized to the intervention group will have more optimized behavioral risk factors including a greater reduction in sodium intake, greater increase in dietary fruit and vegetable intake, and greater increase in physical activity than those in the control group (primary outcome).

Hypothesis 2: Participants randomized to the intervention group will have a greater reduction in systolic blood pressure than those in the control group (secondary outcome).

Hypothesis 3: Participants randomized to the intervention group will have greater reductions in other stroke risk factors such as diastolic blood pressure, fasting serum glucose, body mass index, fasting LDL cholesterol and greater increases in HDL cholesterol than those in the control group (exploratory outcomes).

Hypothesis 4: In exploratory analysis, there will be no interaction between intervention group and ethnicity within a culturally-sensitive, church-based, multicomponent, behavioral intervention to alter sodium intake, fruit and vegetable intake, and physical activity level.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants will be European American or Mexican American residents of Corpus Christi, Texas area and member of a Catholic Church participating in the study
  • greater than 18 years of age
  • speak English or Spanish
  • willing to provide a mailing address and home telephone number to study personnel at the time of consent
  • participants must be able to identify a friend or family partner who is also willing to participate in the study
  • to avoid second level clustering, only two individuals per household (the first to enroll) will be eligible

Exclusion Criteria:

  • Known pregnancy is an exclusion criterion.
  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: NCT01378780

Contacts
Contact: Lewis Morgenstern, MD 734-936-9075 lmorgens@umich.edu

Locations
United States, Texas
Corpus Christi Catholic Churches Recruiting
Corpus Christi, Texas, United States
Sponsors and Collaborators
University of Michigan
Diocese of Corpus Christi, Texas, USA
  More Information

Additional Information:
No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Devin Brown MD MS and Lewis Morgenstern MD, University of Michigan Stroke Program
ClinicalTrials.gov Identifier: NCT01378780     History of Changes
Other Study ID Numbers: R01NS65675
Study First Received: June 15, 2011
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Stroke
hypertension
diet
sodium
physical activity

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

ClinicalTrials.gov processed this record on August 20, 2014