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Stroke Health and Risk Education (SHARE)


N/A
18 Years
N/A
Open (Enrolling)
Both
Stroke, Hypertension

Thank you

Trial Information

Stroke Health and Risk Education (SHARE)


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Sodium intake

Outcome Description:

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

Outcome Time Frame:

12 months

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

R01NS65675

NCT ID:

NCT01378780

Start Date:

May 2011

Completion Date:

June 2014

Related Keywords:

  • Stroke
  • Hypertension
  • Stroke
  • hypertension
  • diet
  • sodium
  • physical activity
  • Hypertension
  • Stroke
  • Cerebral Infarction

Name

Location

Corpus Christi Catholic ChurchesCorpus Christi, Texas