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临床试验/NCT03693768
NCT03693768已完成不适用

Motivational Encouragement With Networks (MEN) for Healthy Eating Activity Resting Together (HEART) Health Study

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Change in physical activity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in physical activity

时间窗: 4 months

Change in weekly physical activity minutes accumulated from baseline measures assessed by employing accelerometry.

次要结局

  • Change in fruit / vegetable intake(4 months)
  • Change in sleep hours nightly(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Larrell L Wilkinson

Assistant Professor

University of Alabama at Birmingham

研究点 (2)

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