Motivational Encouragement With Networks (MEN) for Healthy Eating Activity Resting Together (HEART) Health Study (MEN 4 HEART)

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity
• Intervention / Treatment: Behavioral: Health coaching

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: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health coaching ARM; Participants in this ARM will undergo health coaching for 4 months.	Behavioral: Health coaching; Health coaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity	Change in weekly physical activity minutes accumulated from baseline measures assessed by employing accelerometry.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fruit / vegetable intake	Change in daily fruit and vegetable intake from baseline measures assessed by questionnaire (food log journal).	4 months
Change in sleep hours nightly	Change in nightly sleep hours measured nightly from baseline measures assessed by questionnaire.	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight Measurement	Change in weight (lbs.) from baseline measure assessed via Omron scale.	4 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IRB-300001419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No