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Stroke Health and Risk Education (SHARE) (SHARE)

27 aprile 2015 aggiornato da: Lewis Morgenstern, University of Michigan

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

760

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Texas
      • Corpus Christi, Texas, Stati Uniti
        • Corpus Christi Catholic Churches

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Intervention for diet, exercise
This group will receive the educational intervention for healthy diet and increased physical activity
Comportamentale: 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.
Altro: 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.
Comportamentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Physical activity
Lasso di tempo: 12 months
12 months
Sodium intake
Lasso di tempo: 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
12 months
Fruit/vegetable intake
Lasso di tempo: 12 months
12 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Systolic blood pressure
Lasso di tempo: 12 months
High blood pressure is the number one cause of stroke
12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Michigan

Collaboratori

National Institute of Neurological Disorders and Stroke (NINDS)
Diocese of Corpus Christi, Texas, USA

Pubblicazioni e link utili

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Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2011

Completamento primario (Effettivo)

1 dicembre 2013

Completamento dello studio (Effettivo)

1 dicembre 2013

Date di iscrizione allo studio

Primo inviato

15 giugno 2011

Primo inviato che soddisfa i criteri di controllo qualità

21 giugno 2011

Primo Inserito (Stima)

22 giugno 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

28 aprile 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 aprile 2015

Ultimo verificato

1 aprile 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • R01NS65675

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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