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Effects of Behavioral Stress Reduction Programs on Blood Pressure in African American Youth

13. desember 2012 oppdatert av: Medical University of South Carolina

Stress Reduction: Impact on Blood Pressure in African American Youth

This study will examine the effects of two behavioral stress reduction programs, mindfulness meditation (MM) and the lifeskills program (LP), and a health education control program (CTL) on blood pressure.

Studieoversikt

Detaljert beskrivelse

BACKGROUND:

African Americans (AA) experience a high prevalence and early onset of essential hypertension (EH), which has been partly attributed to exposure to chronic environmental stress. AA youth exhibit higher resting blood pressure (BP) than whites. Since BP ranking tracks from late childhood onward, AA adolescents with high normal BP are at increased risk for development of EH. The need for developing effective primary prevention programs for EH is highlighted by the fact that EH is now a pediatric problem due to recent increased prevalence among youth. There have been no previous controlled studies evaluating stress reduction approaches on BP control in AA youth, particularly within the framework of an underlying psychological and physiological-based model of stress-induced EH.

This study is in response to a 'Request for Applications' entitled "Research on Mind-Body Interactions and Health," which was issued by the Office of the Director, National Institutes of Health (NIH).

DESIGN NARRATIVE:

This study will examine the effects of two behavioral stress reduction programs, MM and LP, and CTL on cardiovascular function at rest, during laboratory stress, and in the natural environment. Participants will include 320 ninth graders (50% male) with high normal systolic BP (SBP) (SBP ranging from greater than or equal to the 50th percentile to less than or equal to the 95th percentile on three occasions). Following BP screenings and baseline evaluation, participants will be assigned to a CTL, MM, LP, or MM plus LP group. Participants will be re-evaluated after a 12-week intervention and again at a 12-week follow-up. The specific aims of this study are to determine whether MM and/or LP results in the following: 1) decreases in the primary outcome variables of resting SBP and 24-hour ambulatory SBP; 2) decreases in sympathetic nervous system (SNS) tone (decreased overnight urine norepinephrine [NE] excretion) and decreases in sodium intake (decreased overnight sodium excretion); 3) decreases in SBP reactivity to behavioral stressors; 4) decreases in SNS arousal (decreased urinary NE excretion) and greater increases in renal function (increased urinary sodium excretion) to the behavioral stressors; 5) decreases in self-reported hostility and anger; 6) improvement in vascular function (increases in percent of endothelium-dependent arterial vasodilation to reactive hyperemia); and 7) improvement in ventricular structure and function (decreases in left ventricular mass index and resting heart rate). It is anticipated that the combination of MM and LP will result in greater positive impacts than either treatment alone. The study will be conducted by teachers during school health classes. If these programs are shown to be successful, they may be incorporated into the regular school curriculum.

Studietype

Intervensjonell

Registrering (Faktiske)

283

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Medical University of South Carolina

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

14 år til 17 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • In ninth grade
  • SBP ranging from greater than or equal to 50th percentile to less than or equal to 95th percentile on three occasions

Exclusion Criteria:

  • Clinical Hypertension

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Health Education Control Program (CTL)
Participants will take part in a health education control program (CTL)
Eksperimentell: Mindfulness Meditation
Mindfulness Meditation (MM) Program
Participants will take part in a mindfulness meditation (MM) program.
Eksperimentell: Lifeskills
Lifeskills Program (LP)
Participants will take part in a lifeskills program (LP).
Eksperimentell: MM plus LP
Mindfulness Meditation (MM) Program plus Lifeskills Program (LP)
Participants will take part in a mindfulness meditation (MM) program.
Participants will take part in a lifeskills program (LP).

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Resting SBP and 24-hour ambulatory SBP
Tidsramme: Measured after 12-week intervention and at 12-week follow-up
Measured after 12-week intervention and at 12-week follow-up

Sekundære resultatmål

Resultatmål
Tidsramme
Overnight urine NE excretion
Tidsramme: Measured after 12-week intervention and at 12-week follow-up
Measured after 12-week intervention and at 12-week follow-up
Overnight sodium excretion
Tidsramme: Measured after 12-week intervention and at 12-week follow-up
Measured after 12-week intervention and at 12-week follow-up
SBP reactivity to behavioral stressors
Tidsramme: Measured after 12-week intervention and at 12-week follow-up
Measured after 12-week intervention and at 12-week follow-up
Self-reported hostility and anger
Tidsramme: Measured after 12-week intervention and at 12-week follow-up
Measured after 12-week intervention and at 12-week follow-up
Percent of endothelium-dependent arterial vasodilation to reactive hyperemia
Tidsramme: Measured after 12-week intervention and at 12-week follow-up
Measured after 12-week intervention and at 12-week follow-up
Left ventricular mass index and resting heart rate
Tidsramme: Measured after 12-week intervention and at 12-week follow-up
Measured after 12-week intervention and at 12-week follow-up

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Frank A. Treiber, Ph.D., Medical University of South Carolina

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2005

Primær fullføring (Faktiske)

1. desember 2009

Studiet fullført (Faktiske)

1. desember 2009

Datoer for studieregistrering

Først innsendt

17. oktober 2005

Først innsendt som oppfylte QC-kriteriene

17. oktober 2005

Først lagt ut (Anslag)

19. oktober 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

17. desember 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. desember 2012

Sist bekreftet

1. desember 2012

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 330
  • R01HL078216 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Kliniske studier på Health Education Control Program (CTL)

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