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

Physical Activity Clinical Trial

— MEN 4 HEART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03693768
• Other study ID #: IRB-300001419
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Health coaching
Health coaching

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Weight Measurement	Change in weight (lbs.) from baseline measure assessed via Omron scale.	4 months
Primary	Change in physical activity	Change in weekly physical activity minutes accumulated from baseline measures assessed by employing accelerometry.	4 months
Secondary	Change in fruit / vegetable intake	Change in daily fruit and vegetable intake from baseline measures assessed by questionnaire (food log journal).	4 months
Secondary	Change in sleep hours nightly	Change in nightly sleep hours measured nightly from baseline measures assessed by questionnaire.	4 months