Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03693768
Recruitment Status : Enrolling by invitation
First Posted : October 3, 2018
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Larrell L Wilkinson, University of Alabama at Birmingham

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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : April 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in physical activity [ Time Frame: 4 months ]
    Change in weekly physical activity minutes accumulated from baseline measures assessed by employing accelerometry.


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Change in Weight Measurement [ Time Frame: 4 months ]
    Change in weight (lbs.) from baseline measure assessed via Omron scale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693768


Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham

Layout table for additonal information
Responsible Party: Larrell L Wilkinson, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03693768     History of Changes
Other Study ID Numbers: IRB-300001419
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No