Stroke Health and Risk Education (SHARE)

NCT01378780 | Completed

• 1 other identifier: R01NS65675
• Study Type: interventional
• Target: 760
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Hypertension

Keywords

Stroke; hypertension; diet; sodium; physical activity

Outcome Measures

Primary Outcomes (3)

• 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

  12 months

• Fruit/vegetable intake

  12 months

• Physical activity

  12 months

Secondary Outcomes (1)

• Systolic blood pressure

  12 months

Study Arms (2)

Intervention for diet, exercise

ACTIVE COMPARATOR

This group will receive the educational intervention for healthy diet and increased physical activity

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.

Behavioral: Educational message on skin cancer awareness

Interventions

Educational intervention for diet and physical activity BEHAVIORAL

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.

Intervention for diet, exercise

Educational message on skin cancer awareness BEHAVIORAL

Control group will get the diet and physical activity intervention after the crossover but no outcomes will be measured after the crossover

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Diocese of Corpus Christi, Texas, USA: collaborator

Study Sites (1)

Corpus Christi Catholic Churches

Corpus Christi, Texas, United States

Location

Related Publications (2)

• 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.

  PMID: 26374480 DERIVED

• Brown 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.

  PMID: 22421317 DERIVED

MeSH Terms

Conditions

Stroke; Hypertension; Motor Activity

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: June 22, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 28, 2015

Record last verified: 2015-04

Locations

US (1)