StrokeSHARENCT01378780
Stroke Health and Risk Education (SHARE)
A study testing Educational intervention for diet and physical activity and Educational message on skin cancer awareness in people with Stroke and Hypertension, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Hypertension
- What is being tested?
- Educational intervention for diet and physical activity and Educational message on skin cancer awareness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known pregnancy is an exclusion criterion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Corpus Christi Catholic Churches
Corpus Christi, Texas
About this study
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.
Read the 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.
- Conditions
- Stroke, Hypertension
- Being tested
- Educational intervention for diet and physical activity, Educational message on skin cancer awareness
- Keywords
- Stroke, hypertension, diet, sodium, physical activity
- Medical subject headings
- Stroke, Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational intervention for diet and physical activityBehavioural
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.
Educational message on skin cancer awarenessBehavioural
Control group will get the diet and physical activity intervention after the crossover but no outcomes will be measured after the crossover
| Study group | Role | What they receive |
|---|---|---|
| Intervention for diet, exercise | Active comparator | This group will receive the educational intervention for healthy diet and increased physical activity Receives: Behavioral: Educational intervention for diet and physical activity |
| Control | Other | 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. Receives: Behavioral: Educational message on skin cancer awareness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sodium intake
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
Measured: 12 months
Fruit/vegetable intake
Measured: 12 months
Physical activity
Measured: 12 months
Secondary outcomes (1)
Systolic blood pressure
High blood pressure is the number one cause of stroke
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 760 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Diocese of Corpus Christi, Texas, USA
- Responsible party
- Principal investigator, Lewis Morgenstern, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378780
- Sponsor's protocol ID
- R01NS65675
- Acronym
- SHARE
- Status last verified
- Apr 2015
- First submitted
- 15 Jun 2011
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Brown DL, Conley KM, Sanchez BN, Resnicow K, Cowdery JE, Sais E, Murphy J, Skolarus LE, Lisabeth LD, Morgenstern LB. A Multicomponent Behavioral Intervention to Reduce Stroke Risk Factor Behaviors: The Stroke Health and Risk Education Cluster-Randomized Controlled Trial. Stroke. 2015 Oct;46(10):2861-7. doi: 10.1161/STROKEAHA.115.010678. Epub 2015 Sep 15.
PubMed 26374480Brown DL, Conley KM, Resnicow K, Murphy J, Sanchez BN, Cowdery JE, Sais E, Lisabeth LD, Skolarus LE, Zahuranec DB, Williams GC, Morgenstern LB. Stroke Health and Risk Education (SHARE): design, methods, and theoretical basis. Contemp Clin Trials. 2012 Jul;33(4):721-9. doi: 10.1016/j.cct.2012.02.020. Epub 2012 Mar 6.
PubMed 22421317
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Health and Risk Education (SHARE)
- ClinicalTrials.gov ID
- NCT01378780
- Acronym / sponsor ID
- SHARE / R01NS65675
- Conditions
- Stroke, Hypertension
- Keywords
- Stroke, hypertension, diet, sodium, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 760 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Diocese of Corpus Christi, Texas, USA
- Study start
- May 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention for diet, exercise | Active comparator | Behavioral: Educational intervention for diet and physical activityThis group will receive the educational intervention for healthy diet and increased physical activity |
| Control | Other | Behavioral: Educational message on skin cancer awarenessThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Known pregnancy is an exclusion criterion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational intervention for diet and physical activityThe 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. | Behavioural | Intervention for diet, exercise |
| Educational message on skin cancer awarenessControl group will get the diet and physical activity intervention after the crossover but no outcomes will be measured after the crossover | Behavioural | Control |
Primary outcome
Sodium intake
Time frame: 12 months
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
Physical activity
Time frame: 12 months
1 secondary outcome
Systolic blood pressure
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Derived from this study: PubMed 26374480Brown DL, Conley KM, Sanchez BN, Resnicow K, Cowdery JE, Sais E, Murphy J, Skolarus LE, Lisabeth LD, Morgenstern LB. A Multicomponent Behavioral Intervention to Reduce Stroke Risk Factor Behaviors: The Stroke Health and Risk Education Cluster-Randomized Controlled Trial. Stroke. 2015 Oct;46(10):2861-7. doi: 10.1161/STROKEAHA.115.010678. Epub 2015 Sep 15.
- Derived from this study: PubMed 22421317Brown DL, Conley KM, Resnicow K, Murphy J, Sanchez BN, Cowdery JE, Sais E, Lisabeth LD, Skolarus LE, Zahuranec DB, Williams GC, Morgenstern LB. Stroke Health and Risk Education (SHARE): design, methods, and theoretical basis. Contemp Clin Trials. 2012 Jul;33(4):721-9. doi: 10.1016/j.cct.2012.02.020. Epub 2012 Mar 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention for diet and physical activity and Educational message on skin cancer awareness in people with Stroke and Hypertension, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sodium intake (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01378780, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.