Stroke Health and Risk Education (SHARE)
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/13/2015 |
| Start Date: | May 2011 |
| End Date: | June 2014 |
| Contact: | Lewis Morgenstern, MD |
| Email: | lmorgens@umich.edu |
| Phone: | 734-936-9075 |
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.
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.
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.
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.
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.
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