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Completed

NCT Number: NCT03693768

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

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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Key information

Age range

45 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Coaching

Behavioral

Health coaching

Primary outcomes

  1. Change in physical activity

    Time frame: 4 months

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

Secondary outcomes

  1. Change in fruit / vegetable intake

    Time frame: 4 months

    Change in daily fruit and vegetable intake from baseline measures assessed by questionnaire (food log journal).

  2. Change in sleep hours nightly

    Time frame: 4 months

    Change in nightly sleep hours measured nightly from baseline measures assessed by questionnaire.

Other outcomes

  1. Change in Weight Measurement

    Time frame: 4 months

    Change in weight (lbs.) from baseline measure assessed via Omron scale.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Acronym: MEN 4 HEART

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 3, 2018
Registry last updated
Jun 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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