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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03693768
Acronym
MEN 4 HEART
Enrollment
34
Registered
2018-10-03
Start date
2019-04-01
Completion date
2022-05-31
Last updated
2022-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity

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.

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.

Interventions

BEHAVIORALHealth coaching

Health coaching

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
45 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in physical activity4 monthsChange in weekly physical activity minutes accumulated from baseline measures assessed by employing accelerometry.

Secondary

MeasureTime frameDescription
Change in fruit / vegetable intake4 monthsChange in daily fruit and vegetable intake from baseline measures assessed by questionnaire (food log journal).
Change in sleep hours nightly4 monthsChange in nightly sleep hours measured nightly from baseline measures assessed by questionnaire.

Other

MeasureTime frameDescription
Change in Weight Measurement4 monthsChange in weight (lbs.) from baseline measure assessed via Omron scale.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026