Cardiovascular Risk FactorNCT03339050
Reducing Cardiovascular Risk of African Americans
A study testing Health for Hearts United in people with Cardiovascular Risk Factor, run by Florida State University.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Health for Hearts United
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- No sites listed yet
- Study dates
- 3 Jun 2008to 31 Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Health for Hearts United
- Keywords
- church-based health promotion, African Americans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health for Hearts UnitedBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Health for Hearts United |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
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.
Measured: 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.
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.
Measured: 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.
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).
Measured: Change from Baseline, 6 months, 18 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start3 Jun 2008
- Primary completion31 Jan 2013
- Study completion31 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Florida A&M University, University of Georgia
- Responsible party
- Principal investigator, Penny Ralston, Florida State University
- Investigators
- Penny A Ralston, Ph.D., Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339050
- Sponsor's protocol ID
- FloridaStateU
- Status last verified
- Nov 2017
- First submitted
- 1 Jul 2017
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 24685998Ralston 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.
PubMed 28115818Wickrama 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.
PubMed 23131815O'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.
PubMed 23456216O'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.
PubMed 23241919McDole 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.
PubMed 23377726Caffo 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.
PubMed 33661054Ralston 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.
PubMed 31866211
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Cardiovascular Risk of Mid-life and Older African Americans
- ClinicalTrials.gov ID
- NCT03339050
- Acronym / sponsor ID
- FloridaStateU
- Conditions
- Cardiovascular Risk Factor
- Keywords
- church-based health promotion, African Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Florida A&M University, University of Georgia
- Study start
- 3 Jun 2008 (actual)
- Primary completion
- 31 Jan 2013 (actual)
- Study completion
- 31 Jan 2013 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Health for Hearts United | Experimental | Behavioral: Health for Hearts UnitedHealth for Hearts United (HHU) is a 18-month church-based intervention to reduce CVD risk in mid-life and older African Americans. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health for Hearts UnitedThe 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. | Behavioural | Health for Hearts United |
Primary outcome
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.
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).
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).
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).
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Results publication: PubMed 24685998Ralston 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.
- Results publication: PubMed 28115818Ralston 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.
- Results publication: PubMed 23131815Wickrama 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.
- Results publication: PubMed 23456216O'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.
- Results publication: PubMed 23241919O'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.
- Results publication: PubMed 23377726McDole 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.
- Derived from this study: PubMed 33661054Caffo 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.
- Derived from this study: PubMed 31866211Ralston 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Penny A Ralston, Ph.D. principal investigator
Florida State University
Questions about this trial
What is this clinical trial studying?
A study testing Health for Hearts United in people with Cardiovascular Risk Factor, run by Florida State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03339050, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.