Clinical trial NCT03339050: Reducing Cardiovascular Risk of African Americans
Official title: Reducing Cardiovascular Risk of Mid-life and Older African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: church-based health promotion
African Americans
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Florida A&M University
name: University of Georgia
First posted: 2017-11-13
Enrollment: 221
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Health for Hearts United is a longitudinal church-based intervention to reduce cardiovascular disease (CVD) risk in mid-life and older African Americans. Using community-based participatory research (CBPR) approaches and undergirded by both the Transtheoretical Model of Behavior Change and Socio-ecological theory, the 18-month intervention was developed in six North Florida churches (three treatment, three comparison).
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Increase in fruit and vegetable consumption assessed by a single item on number of servings of fruits and vegetables consumed daily.
timeFrame: Change from Baseline, 6 months, 18 months and 24 months
measure: Decrease in saturated fat intake (g) as assessed by the multiple pass 24 hour recall.
timeFrame: Change from Baseline, 6 months, 18 months and 24 months
measure: Decrease in total sugar intake (g) as assessed by the multiple pass 24 hour recall.
timeFrame: Change from Baseline, 6 months, 18 months and 24 months
measure: Decrease in total sodium intake (g) as assessed by the multiple pass 24 hour recall.
timeFrame: Change from Baseline, 6 months, 18 months and 24 months
Secondary outcomes:
measure: Increase in habitual physical activity (total kilocalories per week) as assessed by the Yale Physical Activity Scale (YPAS).
timeFrame: Change from Baseline, 6 months, 18 months and 24 months
measure: Decrease in girth circumference of abdomen (cm) as assessed using clinical measurements by trained staff.
timeFrame: Change from Baseline, 6 months, 18 months and 24 months
measure: Decrease in systolic and diastolic blood pressure (mmHg) as assessed using clinical measurements by trained staff.
timeFrame: Change from Baseline, 6 months, 18 months and 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Florida State University
name: Penny A Ralston, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.