Reducing Cardiovascular Risk of African Americans

NCT03339050 | Completed DMC

• 1 other identifier: FloridaStateU
• Study Type: interventional
• Target: 221
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Risk Factor

Keywords

church-based health promotion; African Americans

Outcome Measures

Primary Outcomes (4)

• Increase in fruit and vegetable consumption assessed by a single item on number of servings of fruits and vegetables consumed daily.

  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.

  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.

  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.

  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 Outcomes (3)

• Increase in habitual physical activity (total kilocalories per week) as assessed by the Yale Physical Activity Scale (YPAS).

  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.

  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.

  Change from Baseline, 6 months, 18 months and 24 months

Study Arms (1)

Health for Hearts United

EXPERIMENTAL

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

Interventions

Health for Hearts United BEHAVIORAL

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.

Health for Hearts United

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida State University: lead
• Florida A&M University: collaborator
• University of Georgia: collaborator

Related Publications (8)

• 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.

  PMID: 24685998 RESULT

• 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.

  PMID: 28115818 RESULT

• 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.

  PMID: 23131815 RESULT

• 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.

  PMID: 23456216 RESULT

• 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.

  PMID: 23241919 RESULT

• 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.

  PMID: 23377726 RESULT

• 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.

  PMID: 33661054 DERIVED

• 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.

  PMID: 31866211 DERIVED

MeSH Terms

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Penny A Ralston, Ph.D.

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Dean Emeritus

Model Details: 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).

Study Record Dates

• First Submitted: July 1, 2017
• First Posted: November 13, 2017
• Study Start: June 3, 2008
• Primary Completion: January 31, 2013
• Study Completion: January 31, 2013
• Last Updated: November 13, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share