The FAITH! Trial: A mHealth Intervention to Improve Cardiovascular Health Among African-Americans

NCT03777709 | Completed Results

• 2 other identifiers: 18-0068465R21MD013490
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to apply a community-based participatory research (CBPR) approach to rigorously refine and test the feasibility and preliminary efficacy of an existing cardiovascular (CV) health and wellness digital application (app) prototype to improve CV health according to the American Heart Association Life's Simple 7 (LS7) framework among African-American (AA) adults within faith communities. The investigators hypothesize that the app-based intervention will be feasible and improve LS7 among AAs from baseline to 6-months post-intervention.

Conditions

Cardiovascular Diseases; Physical Activity; Diet Modification; Lifestyle Factors

Outcome Measures

Primary Outcomes (17)

• Life's Simple 7 Composite Score Change

  Change from baseline Life's Simple 7 Composite Score at 6 month post-intervention The Life's Simple 7 Composite Score is adapted from the American Heart Association standards based on health assessment data and is a composite of each component (average BP from 3 readings, fasting lipid panel and glucose, height, weight, self-reported cigarette smoking status, dietary quality, and physical activity patterns). Point values are assigned to each component: 2 points for ideal, 1 point for intermediate, 0 points for poor. The total sum allows for a continuous measure of cardiovascular health ranging from poor to ideal (0-14 points). The final score will be categorized as 0-6 (poor), 7-8 (intermediate), 9-14 (ideal).

  6 months post-intervention

• Blood Pressure Change

  Change from baseline blood pressure at 6 month post-intervention. (average of 3 sitting readings of systolic and diastolic pressures)

  6 months post-intervention

• Fasting Glucose (Fingerstick)

  Change from baseline to 6 months post-intervention fasting glucose

  6 months post-intervention

• Fasting Lipid Panel

  Change in fasting lipid panel from baseline to 6 months post-interventio

  6 months post-intervention

• BMI

  Change from baseline BMI at 6 months post-intervention

  6 months post-intervention

• Smoking Status Category

  Change in the categorical score (poor, intermediate, ideal) of the smoking status LS7 component from baseline to 6 months. Poor = Current Smoker, Intermediate = Former Smoker (\<1 year), Ideal = Never or Former (\>1 year).

  Baseline

• Smoking Status Category

  Change in the categorical score (poor, intermediate, ideal) of the smoking status LS7 component from baseline to 6 months. Poor = Current Smoker, Intermediate = Former Smoker (\<1 year), Ideal = Never or Former (\>1 year).

  6 Months post-intervention

• Dietary Quality (According to American Heart Association Guidelines by the Validated, Culturally Appropriate, Delta Nutrition Intervention Food Frequency Questionnaire-FFQ)

  Dietary quality was measured using a checklist of foods and beverages, self-reported by participants at baseline and 6 months post-intervention. Responses range from never to 2 or more times per day (responses: never, \< once/month, once/month, 2-3 times/month, 1 time/week, 2 times/week, 3-4 times/week, 5-6 times/week, 1 time/day, 2 or more times/day). Nutrient intake was estimated via a computer software, multiplying reported food frequency by nutrient content, following by comparison to AHA guidelines. Healthy diet score include 5 components: 1. fruits and vegetables, ≥4.5 cups/d 2. fish, 2 or more 3.5-oz servings/wk 3. fiber-rich whole grains (≥1.1 g fiber/10 g carbohydrate), 3 or more 1-oz-equivalent servings/d 4. sodium, ≤1500 mg/d 5. sugar-sweetened beverages, ≤450 kcal/wk. Each component equals 1 point, resulting in scores from 0 to 5, which are categorized as Poor (0-1), Intermediate (2-3), or Ideal (4-5). Higher scores indicated better dietary quality.

  Immediate post-intervention

• Dietary Quality (According to American Heart Association Guidelines by the Validated, Culturally Appropriate, Delta Nutrition Intervention Food Frequency Questionnaire-FFQ)

  Dietary quality was measured using a checklist of foods and beverages, self-reported by participants at baseline and 6 months post-intervention. Responses range from never to 2 or more times per day (responses: never, \< once/month, once/month, 2-3 times/month, 1 time/week, 2 times/week, 3-4 times/week, 5-6 times/week, 1 time/day, 2 or more times/day). Nutrient intake was estimated via a computer software, multiplying reported food frequency by nutrient content, following by comparison to AHA guidelines. Healthy diet score include 5 components: 1. fruits and vegetables, ≥4.5 cups/d 2. fish, 2 or more 3.5-oz servings/wk 3. fiber-rich whole grains (≥1.1 g fiber/10 g carbohydrate), 3 or more 1-oz-equivalent servings/d 4. sodium, ≤1500 mg/d 5. sugar-sweetened beverages, ≤450 kcal/wk. Each component equals 1 point, resulting in scores from 0 to 5, which are categorized as Poor (0-1), Intermediate (2-3), or Ideal (4-5). Higher scores indicated better dietary quality.

  6 months post-intervention

• Physical Activity Patterns (Minutes/Week of Moderate and Vigorous Intensity Physical Activity, Measured by the International Physical Activity Questionnaire-IPAQ)

  Change from baseline in the total minutes per week that a participant engaged in moderate and vigorous intensity physical activity at immediate post-intervention.

  Immediate post-intervention

• Physical Activity Patterns (Minutes/Week of Moderate and Vigorous Intensity Physical Activity, Measured by the International Physical Activity Questionnaire-IPAQ)

  Change from baseline to 6 months post-intervention in the total minutes per week that a participant engaged in moderate and vigorous intensity physical activity.

  6 months post-intervention

• Intervention Feasibility Measures - Participant Engagement With Tracking

  Participant engagement with weekly diet/physical activity tracking measured by number of times participant engaged with the tracking feature at immediate post-intervention.

  Immediate post-intervention

• Intervention Feasibility Measures - Participant Engagement With Tracking

  Participant engagement with weekly diet/physical activity tracking measured by number of times participant engaged with the tracking feature at 6 months post-intervention

  6 months post-intervention

• Number of Participants With and Without Engagement With Sharing Board

  Participant engagement with sharing board measured by number of posts per month by each participant at immediate post-intervention

  Immediate post-intervention

• Intervention Feasibility Measures - Participant Engagement With Sharing Board

  Participant engagement with sharing board measured by the number of participants sharing at least one discussion board post during the intervention

  Immediate post-intervention

• Intervention Feasibility Measures - Participant Engagement With Modules

  App engagement as measured by the number of modules completed by the participants during the intervention. The number of participants who completed \<5 and ≥5 modules (out of 10) was calculated.

  Immediate post-intervention

• Intervention Feasibility Measures - App Usability

  App usability assesses four domains (Impact, Perceived usefulness, Perceived ease of use, User control) using the Health Information Technology Usability Evaluation Scale (Health-ITUES) instrument. 20 items are assessed, each on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). The overall Health-ITUES score was calculated as the mean of all 20 items, with each item being equally weighted. Possible total scores range from 1.0 (minimum) to 5.0 (maximum). A higher total sum indicates higher perceived usability of the technology measured at 6 months post-intervention.

  6 months post-intervention

Secondary Outcomes (10)

• Smoking at Baseline as Assessed by Cigarette Smoking Status

  Day 1

• Diet Self-Efficacy

  6 months post-intervention

• Diet Self-Regulation

  6 months post-intervention

• Diet Social Support

  6 months post-intervention

• Physical Activity Self-Efficacy

  6 months post-intervention

Study Arms (2)

Intervention

EXPERIMENTAL

The FAITH! App intervention includes a 10-week core series of multimedia education modules with a LS7 focus and other features including interactive self-quizzes, self-monitoring (diet/physical activity), and social networking. Participants will follow a weekly schedule of each module concentrating on each LS7 component. Personalized messages will be delivered to each participant 3-4 times weekly over the intervention phase through the app dashboard, text message, or email. The sharing board will be moderated weekly to foster discussion on behavior change influences and participant successes/challenges to healthy lifestyle. Participants will maintain app access for the duration of the study.

Behavioral: FAITH! App

Delayed Intervention/Control

NO INTERVENTION

The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).

Interventions

FAITH! App BEHAVIORAL

Participants allocated to the intervention arm will complete a 10-week, individual-tailored intervention program utilizing the FAITH! App to promote the AHA LS7 through health education and to increase awareness and skill development while enhancing self-efficacy, self-regulation, and social support for healthy behavior change.

Intervention

Eligibility Criteria

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

You may qualify if:

• African American race/ethnicity
• years or older
• Own a smart phone
• Have basic Internet navigation skills
• Have at least weekly Internet access (i.e. at home, church, or other public access)
• Have an active email address
• Intake of fruits/vegetables less than 5 servings a day
• No engagement in regular physical activity
• Able to engage in moderate physical activity

You may not qualify if:

• Unable to walk up 2 or more flights of stair or walk more than 1 city block without assistance or stopping
• Pregnant (due to associated hormonal and weight changes)
• Visual/hearing impairment or mental disability that would preclude independent app use

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Brewer LC, Jenkins S, Hayes SN, Kumbamu A, Jones C, Burke LE, Cooper LA, Patten CA. Community-Based, Cluster-Randomized Pilot Trial of a Cardiovascular Mobile Health Intervention: Preliminary Findings of the FAITH! Trial. Circulation. 2022 Jul 19;146(3):175-190. doi: 10.1161/CIRCULATIONAHA.122.059046. Epub 2022 Jul 18.

  PMID: 35861762 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. LaPrincess Brewer
• Organization: Mayo Clinic

brewer.laprincess@mayo.edu

5072661376

Study Officials

• LaPrincess C Brewer

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 17, 2018
• Study Start: February 1, 2020
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: October 2, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)