Cardiovascular Disease Risk FactorsFAITH!NCT02235896
Reducing CVD Risk in African Americans Faith Communities
A study testing Education/Behavior Modification in people with Cardiovascular Disease Risk Factors, run by Mayo Clinic at 1 site in United States.
Trial summary
The ultimate goal of our partnership with local African-American churches is to implement an effective, multi-component intervention to increase awareness of the critical importance of healthy lifestyle in the prevention of cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease Risk Factors
- What is being tested?
- Education/Behavior Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Aug 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18 yrs,
- able to consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Disease Prevention Among African-Americans by FAITH! (Fostering African-American Improvement in Total Health)
The ultimate goal of our partnership with local African-American churches is to implement an effective, multi-component intervention to increase awareness of the critical importance of healthy lifestyle in the prevention of cardiovascular disease (CVD). We will utilize the American Heart Association (AHA) prevention strategy, \"Life's Simple 7\" to address the major risk factors for CVD: diet, smoking, physical inactivity, hypertension, diabetes, cholesterol and obesity in order to improve overall cardiovascular health. Our main strategy consists of a community-based participatory research approach that involves focus groups to assess participant knowledge and beliefs about CVD risk factors prior to program initiation. We will also determine participant dietary and exercise practices, knowledge and perceptions related to healthy lifestyle and chronic diseases, demographic/health status information, health care utilization, biometrics (weight, blood pressure, blood tests for glucose and cholesterol, etc.) and attitudes about medical research at baseline, program completion and 6-month follow-up.
Read the detailed description
Church goers will undergo, baseline assessment of knowledge attitudes and behavior survey as it relates to CVD risk and anthropomorphic measurements. A 3 month experiential educational program will be provided at 2 locations. At 6 months after baseline a followup measure will be obtained
- Conditions
- Cardiovascular Disease Risk Factors
- Being tested
- Education/Behavior Modification
- Keywords
- risk factors, African American, lipids, blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education/Behavior ModificationBehavioural
Education, lifestyle counseling, experiential cooking, exercise classes.
| Study group | Role | What they receive |
|---|---|---|
| Education/Behavior Modification | Other | Education/Behavior modification program Receives: Behavioral: Education/Behavior Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge, attitudes about CVD and CVD risk
Change from baseline in knowledge and attitudes about CVD and CVD risk as measured by survey
Measured: 1 year
Behavior change
Self reported diet composition, physical activity, smoking and stress
Measured: 1 year
Secondary outcomes (2)
CVD Risk factors
weight, lipids, blood glucose, BMI, Blood Pressure, % body fat, waist circumference
Measured: 1 year
Attitudes about participation in Research
Knowledge and attitudes about medical research participation assessed by survey
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Disease Risk FactorsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharonne Hayes, Mayo Clinic
- Investigators
- Sharonne Hayes, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235896
- Sponsor's protocol ID
- 14-004122
- Acronym
- FAITH!
- Status last verified
- Dec 2015
- First submitted
- 5 Sep 2014
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Brewer LC, Morrison EJ, Balls-Berry JE, Dean P, Lackore K, Jenkins S, Cohen C, Johnson J, Ellis F, Mangum DC, Hayes SN, Patten C. Preventing cardiovascular disease: Participant perspectives of the FAITH! Program. J Health Psychol. 2019 Oct;24(12):1710-1723. doi: 10.1177/1359105317695878. Epub 2017 Feb 1.
PubMed 28810418
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Disease Prevention Among African-Americans by FAITH! (Fostering African-American Improvement in Total Health)
- ClinicalTrials.gov ID
- NCT02235896
- Acronym / sponsor ID
- FAITH! / 14-004122
- Conditions
- Cardiovascular Disease Risk Factors
- Keywords
- risk factors, African American, lipids, blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Sep 2014 (estimated)
- 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.
The ultimate goal of our partnership with local African-American churches is to implement an effective, multi-component intervention to increase awareness of the critical importance of healthy lifestyle in the prevention of cardiovascular disease (CVD). We will utilize the American Heart Association (AHA) prevention strategy, \"Life's Simple 7\" to address the major risk factors for CVD: diet, smoking, physical inactivity, hypertension, diabetes, cholesterol and obesity in order to improve overall cardiovascular health. Our main strategy consists of a community-based participatory research approach that involves focus groups to assess participant knowledge and beliefs about CVD risk factors prior to program initiation. We will also determine participant dietary and exercise practices, knowledge and perceptions related to healthy lifestyle and chronic diseases, demographic/health status information, health care utilization, biometrics (weight, blood pressure, blood tests for glucose and cholesterol, etc.) and attitudes about medical research at baseline, program completion and 6-month follow-up.
Detailed description
Church goers will undergo, baseline assessment of knowledge attitudes and behavior survey as it relates to CVD risk and anthropomorphic measurements. A 3 month experiential educational program will be provided at 2 locations. At 6 months after baseline a followup measure will be obtained
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Education/Behavior Modification | Other | Behavioral: Education/Behavior ModificationEducation/Behavior modification program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 yrs,
- able to consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Education/Behavior ModificationEducation, lifestyle counseling, experiential cooking, exercise classes. | Behavioural | Education/Behavior Modification |
Primary outcome
Knowledge, attitudes about CVD and CVD risk
Time frame: 1 year
Change from baseline in knowledge and attitudes about CVD and CVD risk as measured by survey
Behavior change
Time frame: 1 year
Self reported diet composition, physical activity, smoking and stress
2 secondary outcomes
CVD Risk factors
Time frame: 1 year
Attitudes about participation in Research
Time frame: 1 year
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 31 Dec 2015.
- Derived from this study: PubMed 28810418Brewer LC, Morrison EJ, Balls-Berry JE, Dean P, Lackore K, Jenkins S, Cohen C, Johnson J, Ellis F, Mangum DC, Hayes SN, Patten C. Preventing cardiovascular disease: Participant perspectives of the FAITH! Program. J Health Psychol. 2019 Oct;24(12):1710-1723. doi: 10.1177/1359105317695878. Epub 2017 Feb 1.
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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.
Sharonne Hayes, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education/Behavior Modification in people with Cardiovascular Disease Risk Factors, run by Mayo Clinic at 1 site in United States.
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 2 inclusion and 0 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 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Knowledge, attitudes about CVD and CVD risk (time frame: 1 year). The study lists 2 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 NCT02235896, which also lists 1 linked publication.
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 31 Dec 2015.