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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT03693768

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Physical Activity	Behavioral: Health coaching	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 1, 2019

Actual Primary Completion Date :

May 31, 2022

Actual Study Completion Date :

May 31, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Health coaching ARM

Participants in this ARM will undergo health coaching for 4 months.

Behavioral: Health coaching

Health coaching

Outcome Measures

Primary Outcome Measures

Change in physical activity [4 months]
Change in weekly physical activity minutes accumulated from baseline measures assessed by employing accelerometry.

Secondary Outcome Measures

Change in fruit / vegetable intake [4 months]
Change in daily fruit and vegetable intake from baseline measures assessed by questionnaire (food log journal).
Change in sleep hours nightly [4 months]
Change in nightly sleep hours measured nightly from baseline measures assessed by questionnaire.

Other Outcome Measures

Change in Weight Measurement [4 months]
Change in weight (lbs.) from baseline measure assessed via Omron scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Larrell L Wilkinson, Assistant Professor, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT03693768

Other Study ID Numbers:

IRB-300001419

First Posted:

Oct 3, 2018

Last Update Posted:

Jun 2, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 2, 2022