Reducing Cardiovascular Risk of African Americans

November 7, 2017 updated by: Penny Ralston, Florida State University

Reducing Cardiovascular Risk of Mid-life and Older African Americans

Diseases such as hypertension and stroke affect mid-life and older African Americans at higher rates than Whites, negatively affecting health status of this group. This project determine the effectiveness of a faith-based health intervention for mid-life and older African Americans using community-based participatory research approaches.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Mid-life and older African Americans (AAs), a population that is increasing in number, have high rates of cardiovascular-related morbidity and mortality in relation to Whites. For this population, dietary and physical activity behaviors are related to the incidence of cardiovascular disease (CVD). Few tested health promotion interventions tailored for mid-life and older AAs are available yet churches have been shown to be an effective environment for AA health programs. Thus, the overall goal of this project is to reduce CVD risk factors in mid-life and older AAs through implementing and evaluating a church-based health intervention. Using the Transtheoretical Model of Behavior Change (TTM) and Socio-ecological theory (SE), the objectives of this project were to: 1) determine the effectiveness of a church-based intervention in relation to dietary behaviors (food choice, dietary quality), habitual physical activity) and CVD clinical risk factors of mid-life and older African Americans by increasing consumption of fruits, vegetables and calcium-rich foods; decreasing consumption of fat, sugar and sodium; increasing habitual physical activity; and improving selected clinical outcomes (blood pressure, body weight, glucose, among others); 2) identify the differential influence of program components of the intervention; 3) examine variables that might mediate the process of goal achievement; and 4) determine variables that are related to stage of change progression in goal achievement. Midlife and older AAs (n=221) from six churches, three treatment and three comparison, in North Florida were randomly selected from the churches, stratifying by age and gender. The intervention, Health for Hearts United, was developed using a community-based participatory approach and included literature-based conceptual elements of awareness building, clinical learning and efficacy development. Instruments included a food and lifestyle habits questionnaire (food frequency, NCI fruit and vegetable screener, NCI fat screener, physical activity items, TTM items, background characteristics, among others). Clinical data, including 24 hour recall, were collected from a subsample of participants (n=104). Data were collected at four points: Baseline, 6 ,18 and 24 month. The project was guided by research and community advisory committees.

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Not Applicable

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

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 45 years of age or older
  • African American
  • member and regular attender of church (at least twice a month)
  • resident of Gadsden and Leon counties in North Florida.

Exclusion Criteria:

  • Under 45 years of age
  • not African American
  • not a member and regular attender of church
  • not a resident of Gadsden and Leon counties in North Florida.

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
Intervention / Treatment
Experimental: Health for Hearts United
Health for Hearts United (HHU) is a 18-month church-based intervention to reduce CVD risk in mid-life and older African Americans.
Behavioral: Health for Hearts United
The intervention was framed around three conceptual components (awareness building, clinical learning, and efficacy development), and four types of programming (church-initiated, joint programming, standard programming (culturally tailored post cards and newsletters), and data collection health promotion (generic materials, clinical sessions with an Registered Dietitian). Key messages were identified for the intervention including eating better, moving around more, reducing stress, and taking charge of your health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase in fruit and vegetable consumption assessed by a single item on number of servings of fruits and vegetables consumed daily.
Time Frame: Change from Baseline, 6 months, 18 months and 24 months
The single item measure was "How many servings of fruits and vegetables do you usually eat each day?" The item had the following possible responses: zero, one, two, three, four, five and six or more servings daily. The range of scores was zero to six, with six representing the highest number of servings daily and zero representing the lowest.
Change from Baseline, 6 months, 18 months and 24 months
Decrease in saturated fat intake (g) as assessed by the multiple pass 24 hour recall.
Time Frame: Change from Baseline, 6 months, 18 months and 24 months
The multiple pass 24 hour food recall was taken on three days (two week days and one weekend day) by trained interviewers. Data were analyzed using Food Processor (Esha, Salem, Oregon). The unit of measure was grams (g).
Change from Baseline, 6 months, 18 months and 24 months
Decrease in total sugar intake (g) as assessed by the multiple pass 24 hour recall.
Time Frame: Change from Baseline, 6 months, 18 months and 24 months
The multiple pass 24 hour food recall was taken on three days (two week days and one weekend day) by trained interviewers. Data were analyzed using Food Processor (Esha, Salem, Oregon). The unit of measure was grams (g).
Change from Baseline, 6 months, 18 months and 24 months
Decrease in total sodium intake (g) as assessed by the multiple pass 24 hour recall.
Time Frame: Change from Baseline, 6 months, 18 months and 24 months
The multiple pass 24 hour food recall was taken on three days (two week days and one weekend day) by trained interviewers. Data were analyzed using Food Processor (Esha, Salem, Oregon). The unit of measure was grams (g).
Change from Baseline, 6 months, 18 months and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase in habitual physical activity (total kilocalories per week) as assessed by the Yale Physical Activity Scale (YPAS).
Time Frame: Change from Baseline, 6 months, 18 months and 24 months
The Yale Physical Activity Scale (YPAS) uses a simple checklist to provide estimates of caloric expenditure from activity time (minutes per day or week) and activity dimensions (working, yard work, caretaking, exercising, and recreational activities) during a typical day or week. The unit of measure is kilocalories per week (kcal/week) and is computed by converting all activities into minutes per week, multiplying each by an intensity code for kilocalories, and then summing to determine an energy expenditure summary index (kcal/week). The range of possible scores varies per study but the literature on older adult populations suggests low scores on the YPAS in the 300 kcal/week range and high scores of over 20,000 kcal/week.
Change from Baseline, 6 months, 18 months and 24 months
Decrease in girth circumference of abdomen (cm) as assessed using clinical measurements by trained staff.
Time Frame: Change from Baseline, 6 months, 18 months and 24 months
The abdomen was measured in centimeters (cm) with a plastic non-flexible measuring tape (Issaquah, WA). The abdomen was measured at the top of the iliac crest while each participant was exhaling.
Change from Baseline, 6 months, 18 months and 24 months
Decrease in systolic and diastolic blood pressure (mmHg) as assessed using clinical measurements by trained staff.
Time Frame: Change from Baseline, 6 months, 18 months and 24 months
Three blood pressure measurements were taken on the non-dominant arm after each participant rested for a few minutes, using a digital device (A&D Medical, Miltitas, CA). The three readings were then averaged. The unit of measure was millimeter of mercury (mmHg).
Change from Baseline, 6 months, 18 months and 24 months

Collaborators and Investigators

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

Sponsor

Florida State University

Collaborators

University of Georgia
Florida A&M University

Investigators

  • Principal Investigator: Penny A Ralston, Ph.D., Florida State University

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 (Actual)

June 3, 2008

Primary Completion (Actual)

January 31, 2013

Study Completion (Actual)

January 31, 2013

Study Registration Dates

First Submitted

July 1, 2017

First Submitted That Met QC Criteria

November 7, 2017

First Posted (Actual)

November 13, 2017

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

November 7, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FloridaStateU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We have shared the outcomes of the study through local public events in the local community, invited local presentations, newspaper articles, national refereed presentations, and publications. Publications are already available for researcher use.

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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