Motivational Encouragement With Networks (MEN) for Healthy Eating Activity Resting Together (HEART) Health Study
Sponsor:
University of Alabama at Birmingham
Collaborators:
Information provided by (Responsible Party):
Larrell L Wilkinson，University of Alabama at Birmingham
| Tracking Information | |||
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| First Submitted Date ICMJE | June 21, 2018 | ||
| First Posted Date ICMJE | October 3, 2018 | ||
| Last Update Posted Date | October 3, 2018 | ||
| Actual Study Start Date ICMJE | November 1, 2018 | ||
| Estimated Primary Completion Date | June 30, 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures 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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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Motivational Encouragement With Networks (MEN) for Healthy Eating Activity Resting Together (HEART) Health Study |
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| Official Title ICMJE | Motivational Encouragement With Networks (MEN) for Healthy Eating Activity Resting Together (HEART) Health Study |
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| Brief Summary | 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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| Detailed Description | 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. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | N/A | ||
| Study Design ICMJE | Allocation: Intervention Model: Single Group Assignment Intervention Model Description: Masking: Interventional Masking Description: Primary Purpose: Supportive Care |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
30 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | June 30, 2019 | ||
| Estimated Primary Completion Date | June 30, 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria 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 | ||
| Sex/Gender |
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| Ages | 45 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Larrell L Wilkinson，University of Alabama at Birmingham | ||
| Study Sponsor ICMJE | University of Alabama at Birmingham | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | University of Alabama at Birmingham | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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