Motivational Encouragement With Networks (MEN) for Healthy Eating Activity Resting Together (HEART) Health Study
赞助:
University of Alabama at Birmingham
合作者:
信息的提供 (责任方):
Larrell L Wilkinson，University of Alabama at Birmingham
| 追踪信息 | |||
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| 首次提交日期 ICMJE | June 21, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | November 1, 2018 | ||
| 预计主要完成日期 | June 30, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Change in physical activity[ Time Frame: 4 months ] Change in weekly physical activity minutes accumulated from baseline measures assessed by employing accelerometry. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Motivational Encouragement With Networks (MEN) for Healthy Eating Activity Resting Together (HEART) Health Study | ||
| 正式标题 ICMJE | Motivational Encouragement With Networks (MEN) for Healthy Eating Activity Resting Together (HEART) Health Study | ||
| 简要概况 | The purpose of this research study is to determine if a health coaching intervention that includes exercise, good dietary habits, and good relaxation methods helps overweight men improve health and lose weight. The investigator's hope is to enroll 30 men in this research study. |
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| 详细说明 | Health coaching helps patients gain the knowledge, skills, tools and confidence to become active participants in their care so that they can reach self-identified health goals. Health coaching: 1) provides self-management support, 2) bridges gaps between health professionals and patients, 3) helps patients navigate the health care system, 4) offers emotional support, and 5) serves as a continuity figure. The intervention will consist of tailored health coaching, goal setting, and behavioral contracting for healthy actions to create a supportive context for participants that supports health promoting behaviors (HPBs), with efforts to enhance HPB reinforcement through established networks. After baseline assessment, the men will participate in a 45-minute educational meeting with the principal investigator (PI) to discuss self-reported measures from baseline instruments and the importance of health promoting behaviors (HPBs) to overall heart health. Afterwards, a research study team (research trained undergraduate and graduate student assistants) will perform case management and health advisement (bi-weekly continuity phone calls 2x / month) to support protocol adherence and tracking of participant goals over a period of 120 days. The research team will be guided by a coaching manual created for the purposes of the study. The M for H study will also create and provide health-oriented emails (2x / week), daily tracking text messaging on weekdays, monthly face-to-face coaching group meetings during community-based organization (CBO) set times (i.e. meetings, events), and access to an optional social media platform supporting peer interactions. After 120 days, participants will be reassessed to determine impacts related physical activity (PA) measures, knowledge, attitudes, & practices (KAPs), and interviewed to discuss M for H feasibility and acceptability. The targeted outcome for the 120 day period will be improvement toward the performance of >150 minutes of moderate to vigorous physical activity accumulated as indicated by accelerometry, increase in distance walked during a six (6) minute walk test, and improvement in theoretical construct measures indicative of performance of HPBs among participants. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Supportive Care |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
30 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | June 30, 2019 | ||
| 预计主要完成日期 | June 30, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: Participants will be eligible if they are African American (AA) men: - 45 - 75 years of age at initial enrollment in the study - Overweight (BMI 25 - 29.99) - Obese (BMI 30 - 44.99) - Sufficiently inactive (i.e. self-report accumulating <90 minutes/week of moderate or vigorous physical activity) - Categorized as low or moderate risk in accordance with American College of Sports Medicine (ACSM) guidelines for pre-exercise screening Exclusion Criteria: - Younger than 45 years - Not able to speak or read English - Life expectancy of less than 1 year - Categorization of high risk in accordance with ACSM guidelines - Identified by one's primary care clinician as unable to follow instructions because of physical or cognitive disability - Psychiatric illness - Other unidentified reasons as determined by the investigators | ||
| 性别 |
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| 年龄 | 最小年龄：45 Years ，最大年龄：75 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Larrell L Wilkinson，University of Alabama at Birmingham | ||
| 研究赞助商 ICMJE | University of Alabama at Birmingham | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | University of Alabama at Birmingham | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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