- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03339050
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.
|
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
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
- Ralston PA, Lemacks JL, Wickrama KK, Young-Clark I, Coccia C, Ilich JZ, Harris CM, Hart CB, Battle AM, O'Neal CW. Reducing cardiovascular disease risk in mid-life and older African Americans: a church-based longitudinal intervention project at baseline. Contemp Clin Trials. 2014 May;38(1):69-81. doi: 10.1016/j.cct.2014.03.003. Epub 2014 Mar 28.
- Ralston PA, Young-Clark I, Coccia C. The Development of Health for Hearts United: A Longitudinal Church-based Intervention to Reduce Cardiovascular Risk in Mid-life and Older African Americans. Ethn Dis. 2017 Jan 19;27(1):21-30. doi: 10.18865/ed.27.1.21.
- Wickrama KA, Ralston PA, O'Neal CW, Ilich JZ, Harris CM, Coccia C, Young-Clark I, Lemacks J. Life dissatisfaction and eating behaviors among older African Americans: the protective role of social support. J Nutr Health Aging. 2012;16(9):749-53. doi: 10.1007/s12603-012-0404-6.
- O'Neal CW, Wickrama KA, Ralston PA, Ilich JZ, Harris CM, Coccia C, Young-Clark I, Lemacks J. Health insurance status, psychological processes, and older African Americans' use of preventive care. J Health Psychol. 2014 Apr;19(4):491-502. doi: 10.1177/1359105312474911. Epub 2013 Mar 1.
- O'Neal CW, Wickrama KK, Ralston PA, Ilich JZ, Harris CM, Coccia C, Young-Clark I, Lemacks J. Eating behaviors of older African Americans: an application of the theory of planned behavior. Gerontologist. 2014 Apr;54(2):211-20. doi: 10.1093/geront/gns155. Epub 2012 Dec 14.
- McDole M, Ralston PA, Coccia C, Young-Clark I. The development of a tracking tool to improve health behaviors in African American adults. J Health Care Poor Underserved. 2013 Feb;24(1):171-84. doi: 10.1353/hpu.2013.0003.
- Caffo O, Ralston PA, Lemacks JL, Young-Clark I, Wickrama KKAS, Ilich JZ. Sex and Body Circumferences Associated with Serum Leptin in African American Adults. J Womens Health (Larchmt). 2021 Dec;30(12):1769-1777. doi: 10.1089/jwh.2020.8820. Epub 2021 Mar 3.
- Ralston PA, Wickrama KKAS, Coccia CC, Lemacks JL, Young-Clark IM, Ilich JZ. Health for Hearts United Longitudinal Trial: Improving Dietary Behaviors in Older African Americans. Am J Prev Med. 2020 Mar;58(3):361-369. doi: 10.1016/j.amepre.2019.09.024. Epub 2019 Dec 19.
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
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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