Physical Activity Program for Cardiac Health Among Older African American Populations

April 26, 2021 updated by: University of Alabama, Tuscaloosa

Physical Activity Program for Cardiac Health Among Older African American Populations Living in Rural Alabama: Needs Assessment and Initial Development

Cardiovascular Diseases (CVD) are the leading cause of morbidity and mortality globally, and older African Americans (AAs) living in rural areas are disproportionately affected by this healthcare problem. The investigators propose conducting a mixed-methods study to gain information about CVD-related knowledge, perceptions regarding CVD-related healthcare needs, preferences and access barriers, and cultural aspects within this population. The information will be used in tailoring an existing intervention to meet those needs and preferences and evaluate its feasibility among older AAs living in rural Alabama. This study will lay a foundation for developing a federal grant application and a line of independent research by this early-stage investigator.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cardiovascular diseases (CVD) are a leading cause of morbidity and mortality. Older populations are inherently more vulnerable to such conditions. Older African American (AA) populations living in rural areas are disproportionately affected by CVD, which has been shown to cause an increased risk for mortality in this population. Evidence suggests using lifestyle Physical activity programs to prevent CVD risk factors, which can decrease the morbidity and mortality rates associated with these health conditions. There are limited resources and healthcare services available to these populations, especially those living in Alabama's black belt. Therefore, this research project proposes conducting a phased mixed-methods study to collect data from rural AA older adults. These data are the critical first step towards developing a culturally sensitive, accessible, and acceptable intervention that addresses their needs and risk factors, incorporates their preferences, and mitigates identified barriers, which will be tested for feasibility and acceptability in this pilot study. The aims for this study are Aim 1: Through survey and interviews, assess: i) the knowledge and perceptions of AA older adults living in rural Alabama regarding CVD-related risk factors; ii) the needs/existing resources and access barriers for a community-based physical activity program; iii) the perceptions about a proposed intervention and its components, method of delivery, time/effort, and incentives; and iv) the cultural preferences regarding recruitment strategies, treatment strategies, and incentives. Aim2a: Based on the findings of Aim 1, develop a PA program for improving CVD-related risk factors among older AA populations living in rural Alabama. Aim2b: To examine the feasibility and acceptability of delivering a PA program (developed in Aim 2a) among the older AA populations living in rural Alabama. The enhanced program would enable AA older populations to prevent and manage CVD-related risk factors. It will also help in filling the gap of health disparity between AAs and other ethnicities.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Mudasir Andrabi, Ph D
  • Phone Number: 4432045623
  • Email: MANDRABI@UA.EDU

Study Contact Backup

  • Name: Mercy Mumba, Ph D
  • Phone Number: 2055305439
  • Email: MMUMBA@UA.EDU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • AA women above 65 years of age
  • residing in a community setting of rural Alabama
  • diagnosis of CVD
  • two or more CVD-related risk factors
  • able to speak and understand English
  • physically inactive (engaging in no structured ambulatory/walking based lifestyle physical activity),
  • able to understand and participate in basic elements (informed consent, components of intervention) of the study.

Exclusion Criteria:

  • medical co-morbidity or any acute illness or frailty that would prevent their participation in the physical activity component,
  • history of more than two falls in the last two months
  • suicidal ideation
  • scoring below 22 on Mini-Mental Status Examination Scale
  • lack of transportation to the research sites
  • concurrent participation in any other heart health or Physical activity intervention study.
  • engaged in any kind of ambulatory/walking-based lifestyle physical activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Needs assessment and feasibility group
Based on our target population's needs/preferences, an existing Physical Activity (PA) program will be modified and tailored to the needs of the target population. We anticipate that this PA program will include the following components: a) PA component - ( duration of walk) from baseline to the end of the study; b) weekly informational sessions on various topics related to CVD risk factors prevention; c) daily diary to record if they are facing any barriers in completing various components of the intervention; d) problem-solving sessions
Behavioral: Physical Activity Cardiac Health Program
The investigators anticipate that the physical activity program will include the following components: a) physical activity component - the investigators propose an incremental physical activity component whereby participants will gradually increase their physical activity ( duration of walk) from baseline to the end of the study; b) weekly informational sessions on various topics related to Cardiovascular disease risk factors prevention; c) daily diary, which will be used to document record about any barriers for completing various components of the intervention; d) problem-solving sessions whereby participants will meet once a week with the investigators to talk about the barriers and facilitators of their weekly activity and any adherence issues.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical Activity
Time Frame: 12 Weeks

The investigators will measure the leisure-time physical activity including walk. This will be measured by an accelerometer which gives more accurate information about the ambulation of a person. Scores can range between 0 and infinite.

The higher the score, the better is the outcome.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama, Tuscaloosa

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Alabama at Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mudasir Andrabi, Ph D, The University of Alabama
  • Study Director: Robert Motl, Ph D, The University of Alabama at Birmingham
  • Study Director: Karlene Ball, Ph D, The University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 000526161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators expect that the results of the proposed study will be of great interest to the scientific community. Investigators will collect and analyze the data for the course of the study and allow one calendar year from the end of the budget period to complete data analysis and publication of results. In the interim, data will be presented at scientific meetings and shared with providers and clinicians, surrounding prevention and treatment centers, and appropriate councils and organizations, such as the Alabama Department of Public Health and academic institutions with a curriculum focused on Cardiovascular disease prevention education. The findings will be disseminated using peer-reviewed journals and presentations at local, national, and international conferences. All these avenues are instrumental in the successful dissemination of the research findings. The investigators will also ensure that the NIA has access to our data through clinicaltrials.gov.

IPD Sharing Time Frame

Immediately following publication- 36 months following publication

IPD Sharing Access Criteria

Anyone who wish to access the data.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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