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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03777709
• Other study ID #: 18-006846
• Secondary ID: 5R21MD013490
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: June 23, 2022

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: June 23, 2022
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. African American race/ethnicity

2. 18 years or older

3. Own a smart phone

4. Have basic Internet navigation skills

5. Have at least weekly Internet access (i.e. at home, church, or other public access)

6. Have an active email address

7. Intake of fruits/vegetables less than 5 servings a day

8. No engagement in regular physical activity

9. Able to engage in moderate physical activity

Exclusion criteria:

1. Unable to walk up 2 or more flights of stair or walk more than 1 city block without assistance or stopping

2. Pregnant (due to associated hormonal and weight changes)

3. Visual/hearing impairment or mental disability that would preclude independent app use

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diet Modification
• Lifestyle Factors
• Physical Activity

Intervention

Behavioral:
• FAITH! App
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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Fasting Glucose (Fingerstick)	Change from baseline to 6 months post-intervention fasting glucose	6 months post-intervention
Primary	Fasting Lipid Panel	Change in fasting lipid panel from baseline to 6 months post-interventio	6 months post-intervention
Primary	BMI	Change from baseline BMI at 6 months post-intervention	6 months post-intervention
Primary	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
Primary	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
Primary	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: fruits and vegetables, =4.5 cups/d; fish, 2 or more 3.5-oz servings/wk; fiber-rich whole grains (=1.1 g fiber/10 g carbohydrate), 3 or more 1-oz-equivalent servings/d; sodium, =1500 mg/d; 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
Primary	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: fruits and vegetables, =4.5 cups/d; fish, 2 or more 3.5-oz servings/wk; fiber-rich whole grains (=1.1 g fiber/10 g carbohydrate), 3 or more 1-oz-equivalent servings/d; sodium, =1500 mg/d; 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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Smoking at Baseline as Assessed by Cigarette Smoking Status	Self reported smoking status at baseline. Participants were asked to self-report current smoking status as "no" (non-smoker currently) or "yes" (current smoker). "Missing" category title indicates the survey response was unanswered.	Day 1
Secondary	Diet Self-Efficacy	Changes from baseline to 6 months post-intervention in diet self-efficacy measured a 5-item scale to assess the participant's confidence in their ability to maintain a healthy diet when faced with common barriers. Each item is scored on a scale ranging from 0 (certain I cannot) to 100 (certain I can). A mean was calculated to obtain an overall score ranging from 0 (minimum) to 100 (maximum). The difference between the mean scores is calculated. A larger difference indicates larger change in self-efficacy for healthy eating. A negative change between baseline and 6 months post-intervention indicates worsened diet self-efficacy.	6 months post-intervention
Secondary	Diet Self-Regulation	Changes from baseline to 6 months post-intervention in diet self-regulation measured by the Health Beliefs Survey to assess strategies used in the past 3 months to eat healthier foods. Items are measured on a five-point scale from 1 (never) to 5 (always). A mean of all items is obtained and a difference between the scores is calculated. Higher change in scores indicate more change in use of self-regulation strategies to promote healthy eating.	6 months post-intervention
Secondary	Diet Social Support	Changes from baseline to 6 months post-intervention in diet social support using the Social Support for Eating Habits Survey scale. This scale assesses the level of encouragement or discouragement from family and friends that participants received for adopting healthier eating habits. 5 questions were asked to assess the degree of encouragement and discouragement, separately, on a 5-point scale [from 1 (none) to 5 (very often)]. Each sub-item was summed to obtain a score ranging from 5 (lowest) to 25 (highest discouragement/encouragement). The change in level of diet social support was calculated from baseline to 6 months post-intervention. Higher scores indicate more change in social support for healthy eating.	6 months post-intervention
Secondary	Physical Activity Self-Efficacy	Changes from baseline to 6 months post-intervention in physical activity self-efficacy measured using the Exercise Confidence Survey. The scale assesses the participant's confidence in their ability to exercise when faced with common barriers. 12 items are assessed, each on a 5-point scale ranging from 1 to 5. A mean of 8 items (Exercise confidence: Sticking to it) and 4 items (Exercise confidence: Making time for exercise) are obtained. The difference between baseline and 6 months post-intervention scores is calculated. A higher score indicates higher change in self-efficacy for physical activity.	6 months post-intervention
Secondary	Physical Activity Self-Regulation	Changes from baseline to 6 months post-intervention in physical activity self-regulation measured by the Health Beliefs Survey to assess strategies used in the past 3 months to increase their step count or physical activity levels. Items are measured on a 10-item five-point scale from 1 (never) to 5 (always). The mean of the ten items is obtained. The difference in the mean scores from baseline to 6 months post-intervention is calculated. Larger change in scores indicate more change in self-regulation.	6 months post-intervention
Secondary	Physical Activity Social Support	Changes from baseline to 6 months post-intervention in diet social support using the Social Support for Exercise Survey scale. This scale assesses the level of encouragement or discouragement from family and friends that participants received for adopting healthier physical activity habits. 5 questions were asked to assess the degree of encouragement and discouragement, separately, on a 5-point scale [from 1 (none) to 5 (very often)]. Each sub-item was summed to obtain a score ranging from 5 (lowest) to 25 (highest discouragement/encouragement). The change in level of physical activity social support was calculated from baseline to 6 months post-intervention. Higher scores indicate more change in social support for physical activity. Family Participation was calculated as a sum of 10 items: 10 = low to 50 = high; Family Rewards/Punishment as a sum of 3 items: 3 = low to 15 = high; and Friend Participation sum of 10 items: 10 = low to 50 = high.	6 months post-intervention
Secondary	Psychosocial Measures - Religiosity/Spirituality	Changes from baseline to 6 months post-intervention in Daily Spiritual Experiences Scale. Scores range from 1 to 6 (attendance), from 1 to 8 (prayer), and from 1 to 4 (religious coping), and from 6 to 36 (spirituality), with higher scores on each measure indicating greater religiosity.	6 months post-intervention
Secondary	Psychosocial Measures - Optimism	Changes from baseline to 6 months post-intervention in life orientation test-revised scale. Scores range from 6 (least optimistic) to 24 (most optimistic). Participants respond to 3 positively worded items and 3 negatively worded items. Higher scores indicate more optimism.	6 months post-intervention
Secondary	Psychosocial Measures - Perceived Stress	Changes from baseline to 6 months post-intervention in global perceived stress scale. The instrument measures global perceptions of stressful experiences over the prior 12 months in domains such as employment, legal issues, and racism/discrimination. Participants rate the severity of each domain according to a range from 1 (not stressful) to 3 (very stressful), with a total sum ranging from 0 to 24. Higher total scores indicate more perceived stress.	6 months post-intervention

External Links

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