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Effects of Health Promoting Programs on Cardiovascular Disease Risk

6 maart 2017 bijgewerkt door: Gailen D. Marshall Jr., MD PhD, University of Mississippi Medical Center

Effects of Health-Promoting Programs on Cardiovascular Disease Risk: JHS

The overall approach to the study is to assess the feasibility of recruiting African Americans to participate in several health-promoting programs and to compare health outcomes among the three interventions.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The project is designed to achieve five specific aims: (1) To determine the feasibility of attracting African Americans into Health Promotion Research studies;(2) To determine whether clinically recorded information can be used as a guide for recruitment inclusion in Health Promotion Studies from an active epidemiological research cohort;(3) To measure the ability to retain African Americans recruited into Health Promotion Studies from an active research cohort;(4) To measure the adherence to various protocols within a Health promotion Study; and(5) To provide informed estimates of effect sizes for designing future Health Promotion Research.

A total of 375 study participants from the Jackson Heart Study (JHS) cohort, all of whom are African American, will be randomly assigned to one of five, equally-sized study arms: (1) practicing yoga three times per week; (2) practicing yoga two times per week; (3) practicing yoga one time per week; (4) walking briskly three times per week; and (5) attending a weekly healthy lifestyles class.

All study arms will include a 24-week intervention. In addition, participants will have a total of four clinical visits with members of the study team baseline, 12 weeks, 24 weeks, and 48 weeks) in which the following measures will be recorded:

  1. Systolic and diastolic blood pressure and heart rates
  2. Highly sensitive C-reactive protein (hsCRP) - serum, fibrinogen - plasma (sodium citrate), homocysteine (plasma), and interleukin-6 levels (IL-6) (serum).
  3. Fasting total cholesterol, low density (LDL), direct high density lipoprotein (HDL), and triglyceride levels - all serum
  4. HbA1c level
  5. BMI, waist circumference
  6. Medication and supplement use and dosages
  7. Results of a study survey designed to measure participants' changes in their reported health-related quality of life, perceived stress, health behaviors, sleep patterns, and impact of pain on everyday life

In addition, we will also record systolic and diastolic blood pressure and heart rates before and after each intervention session for all five study arms.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

375

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Mississippi
      • Jackson, Mississippi, Verenigde Staten, 39216
        • University of Mississippi Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • This study includes only one inclusion criterion: to participate in this study, one needs to be a member of the Jackson Heart Study cohort.

Exclusion Criteria:

  • 1. Newly diagnosed (within the last six weeks) with a myocardial infarction, cerebrovascular disease, atrial fibrillation, cardiomyopathy, valvular heart disease, fatal cardiac arrhythmia, severe systolic and diastolic heart failure, uncontrolled COPD, uncontrolled moderate to severe hypertension, or a recent recipient of a pacemaker, and/or

    2. Change in blood pressure medicine or lipid-lowering medication up to 30 days prior to or plans for a change in the 30 days after enrollment in the study, and/or

    3. Already practicing yoga at least once per week or walking briskly for one hour at least three times per week, and/or

    4. Inability to attend protocol sessions, and/or

    5. Diagnosis of an underlying medical illness that might be considered by the principal investigator to potentially impair one's safety or ability to complete the study protocol (example could possibly include uncontrolled asthma), and/or

    6. Current use of a prescription regimen that might be considered by the principal investigator to potentially impair one's safety or ability to complete the study protocol (examples could possibly include use of sedatives or other drugs that could affect a participant's ability to participate in any of the study arms).

    7. Pregnant or planning to become pregnant in the next six (6) months.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Yoga 3 times per week
Yoga participation 3 x per week for 24 weeks; 48 week follow-up.
Ander: Yoga
The yoga intervention, which is taught based on Hatha yoga, will be offered to study participants in Study Arms 1, 2, and 3, is a combination of asanas (poses), pranayams (breathing exercises), and meditation. Blood pressure and heart rate measurements are taken before and after each session.
Ander: Yoga 2 times per week
Yoga participation 2 x per week for 24 weeks; 48 week follow-up
Ander: Yoga
The yoga intervention, which is taught based on Hatha yoga, will be offered to study participants in Study Arms 1, 2, and 3, is a combination of asanas (poses), pranayams (breathing exercises), and meditation. Blood pressure and heart rate measurements are taken before and after each session.
Ander: Yoga 1 time per week
Yoga participation 1 x per week for 24 weeks; 48 week follow-up
Ander: Yoga
The yoga intervention, which is taught based on Hatha yoga, will be offered to study participants in Study Arms 1, 2, and 3, is a combination of asanas (poses), pranayams (breathing exercises), and meditation. Blood pressure and heart rate measurements are taken before and after each session.
Ander: Walking 3 times per week
Walking 3x per week for 24 weeks; 48 week follow-up
Ander: Walking
The walking intervention, which is Study Arm 4 includes, three guided walking sessions per week for 24 weeks. Each class is an hour in length and will include a minimum of 30 minutes of walking at the equivalent of a minimum of three miles per hour. Each session includes a ten-minute warm-up and ten-minute cool-down period of some stretches and walking at a leisurely pace. Blood pressure and heart rate measurements are taken before and after each session.
Ander: Healthy Lifestyles Education
Healthy Lifestyles Education Participation 1 x per week for 24 weeks; 48 week follow-up
Ander: Healthy Lifestyles Education
Participants randomly assigned to the fifth study arm attend one 60-minute healthy lifestyles class per week for 24 weeks. The Healthy Lifestyles curriculum includes 24 independent lesson modules, which allows participants to begin their intervention at any time during the course schedule. Blood pressure and heart rate measurements are taken before and after each session.
Andere namen:
  • Gezondheidsopleiding

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Primary outcomes for this feasibility study will focus on composite measures for recruitment, retention, and the reasons for refusal or dropout.
Tijdsspanne: Bi-annual for up to 52 weeks after enrollment
Primary outcomes for this feasibility study will focus on measures for recruitment, retention, and the reasons for refusal or dropout, and consist of (1) agreement to participate in the study (recruitment); (2) reasons for participating/not-participating; (3) dropout, defined as a monotone missingness pattern of stopping participation before completion of the study; (4) reasons for discontinuation/dropout; (5) attendance, defined as the potentially non-monotone pattern of coming to the scheduled study session; and (6) adherence, defined as attending and completing the scheduled sessions and clinical visits.
Bi-annual for up to 52 weeks after enrollment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in participants' hypertension profiles.
Tijdsspanne: 48 weeks
Defined using measures of their systolic and diastolic blood pressure
48 weeks
Changes in participants' inflammation markers
Tijdsspanne: 48 weeks
Defined using measures of participants' hsCRP, fibrinogen, homocysteine, and interleukin-6 levels.
48 weeks
Changes in participants' lipids profiles.
Tijdsspanne: 48 weeks
Defined as using measures of participants' fasting total cholesterol, LDL, HDL, and triglycerides.
48 weeks
Changes in participants' HbA1c levels.
Tijdsspanne: 48 weeks
Changes in participants' HbA1c levels.
48 weeks
Changes in participants' reported health-related quality of life.
Tijdsspanne: 48 weeks
Quality of life measured as measured by perceived stress, health behaviors, sleep patterns, and impact of pain on everyday life.
48 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Mississippi Medical Center

Onderzoekers

  • Hoofdonderzoeker: Gailen D Marshall, MD, PhD, University of Mississippi Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2012

Primaire voltooiing (Werkelijk)

1 september 2014

Studie voltooiing (Werkelijk)

1 september 2014

Studieregistratiedata

Eerst ingediend

30 april 2013

Eerst ingediend dat voldeed aan de QC-criteria

23 december 2013

Eerst geplaatst (Schatting)

24 december 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 maart 2017

Laatste update ingediend die voldeed aan QC-criteria

6 maart 2017

Laatst geverifieerd

1 maart 2017

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2010-0057

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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