이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Effects of Health Promoting Programs on Cardiovascular Disease Risk

2017년 3월 6일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

375

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Mississippi
      • Jackson, Mississippi, 미국, 39216
        • University of Mississippi Medical Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Yoga 3 times per week
Yoga participation 3 x per week for 24 weeks; 48 week follow-up.
다른: 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.
다른: Yoga 2 times per week
Yoga participation 2 x per week for 24 weeks; 48 week follow-up
다른: 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.
다른: Yoga 1 time per week
Yoga participation 1 x per week for 24 weeks; 48 week follow-up
다른: 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.
다른: Walking 3 times per week
Walking 3x per week for 24 weeks; 48 week follow-up
다른: 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.
다른: Healthy Lifestyles Education
Healthy Lifestyles Education Participation 1 x per week for 24 weeks; 48 week follow-up
다른: 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.
다른 이름들:
  • 보건 교육

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Primary outcomes for this feasibility study will focus on composite measures for recruitment, retention, and the reasons for refusal or dropout.
기간: 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

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Mississippi Medical Center

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2012년 7월 1일

기본 완료 (실제)

2014년 9월 1일

연구 완료 (실제)

2014년 9월 1일

연구 등록 날짜

최초 제출

2013년 4월 30일

QC 기준을 충족하는 최초 제출

2013년 12월 23일

처음 게시됨 (추정)

2013년 12월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 3월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 3월 6일

마지막으로 확인됨

2017년 3월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2010-0057

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

심혈관 질환에 대한 임상 시험

Yoga에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Bahamas

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다