NCT02235896

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 31, 2015

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

September 5, 2014

Last Update Submit

December 30, 2015

Conditions

Keywords

risk factors, African American, lipids, blood pressure

Outcome Measures

Primary Outcomes (2)

  • Knowledge, attitudes about CVD and CVD risk

    Change from baseline in knowledge and attitudes about CVD and CVD risk as measured by survey

    1 year

  • Behavior change

    Self reported diet composition, physical activity, smoking and stress

    1 year

Secondary Outcomes (2)

  • CVD Risk factors

    1 year

  • Attitudes about participation in Research

    1 year

Study Arms (1)

Education/Behavior Modification

OTHER

Education/Behavior modification program

Behavioral: Education/Behavior Modification

Interventions

Education, lifestyle counseling, experiential cooking, exercise classes.

Education/Behavior Modification

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 yrs,
  • able to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Educational StatusBehavior Therapy

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sharonne Hayes, MD

    Mayo Clinic

    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 of Medicine, Cardiovascular Diseases

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 10, 2014

Study Start

September 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

December 31, 2015

Record last verified: 2015-12

Locations