Clinical trial NCT04791618: MECA Clinical Intervention ( MECA Health360x)
Official title: Impact of Technology-based Intervention for Improving Self-management Behaviors in Black Adults; Sub-project of Biological and Socio-cultural Determinants and Management of Cardiovascular Health Factors in Multi-ethnic Populations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Health
Self-management
Keywords: Cardiovascular health risk
e-health lifestyle intervention
ehealthystrides
Life simple 7
Health coach
Health equity
Behavioral intervention
Hypertension
Obesity
Diabetes Mellitus
Helath360x
Tobacco use
Lead sponsor: Morehouse School of Medicine
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2021-03-10
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to test whether a technology application(Health360x) that lets participants set goals for better health and track health can help participants reduce their heart disease risk. Investigators will compare life style intervention using Health360x alone with Health360xs plus health coach on AHA(American Heart Association) LS7 scores after 6 months.

Detailed description: Study volunteers' participation in this study will last for 6 months. Investigators will ask participants to examine their own health behaviors. The purpose of the examination is to find the areas that need improvement so participants can work on them. Investigators will use technology in the form of Health360x to support participant efforts to change health behaviors.

This list below, shows the activities you will perform as part of this research.

Arm A ='High tech' Arm B='High tech high touch"

1. Recruitment Phone call: During this call, investigators will do the following:

   * Collect email address
   * Phone# that can receive text messages
   * Contact information for 2 close friends/relatives
2. Investigators will email participants enrollment and welcome package that contains links to the

   * Online screening form
   * Consent form Please complete both forms
3. Investigators will send participants a link to online training videos and Health360x user manual that show how to use health360x and the online user manual

   • Participants will show investigative team that they know how to use Health360x by completing a proficiency test
4. Investigators will have Live chat sessions to answer questions about the project by the health coach and PI. Participants can access these as needed
5. Participants will be assigned by chance, to High tech only(Arm A) or high tech and high touch(Arm B). Participant will receive an email notification of what study arm they are enrolled in
6. Self- assessment; LS7 score
7. Participant will receive a sleep/activity tracker; Investigators will work to obtain a Blood Pressure monitor through participants' usual health insurance
8. Weekly goal setting; personal action plan x4 weeks Arm A participants will receive email prompts to complete. Arm B participants will complete; 45minute-1 hour meetings with health coach (recorded)
9. Every 2-week goal setting; personal action plans x4 Arm A participants will receive email prompts to complete; Arm B participants will complete 45 minute-1 hour long meetings with health coach(recorded)
10. Every 1 monthly goal setting; personal action plan x3 Arm A participants will receive email prompts to complete; Arm B participants will complete 45 minute-1 hour long meetings with health coach(recorded)

Eligibility criteria: Inclusion Criteria:

* Already participating in baseline clinical study
* Volunteers with AHA LS7 scores of 4 or lower who have access to internet (community or personal),self-reported ability to participate in physical activity, and English fluency.

Exclusion Criteria:

* CAD documented by CAD diagnosis or prior acute myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, or chronic angina; aortic stenosis; inability to participate in increased physical activity; history of alcohol or drug abuse or psychiatric diagnosis that would interfere with ability to participate.

Pregnant and/or breastfeeding women will be excluded. Cognitive deficits severe enough to preclude participation or any medical or surgical problem that precludes meaningful participation; unwillingness to use the internet

Primary outcomes:
measure: Life Simple 7(LS7 the metrics for defining ideal cardiovascular health) score at 6-month follow-up
timeFrame: 6 months
Secondary outcomes:
measure: Self management skills acquired
timeFrame: 6 months
measure: Change in Systolic Blood Pressure:
timeFrame: Baseline, Month 6
measure: Change in Diastolic Blood Pressure
timeFrame: Baseline, Month 6
measure: Change in Delta Nutrition Intervention Research Initiative Food Frequency Questionnaire (Delta NIRI FFQ)
timeFrame: Baseline, Month 6
measure: Change in Blood Glucose
timeFrame: Baseline, Month 3, Month 6
measure: Change in Distance Walked Daily
timeFrame: Baseline, Month 3, Month 6
measure: Change in Short Form-12 Health Survey Questionnaire (SF-12) score
timeFrame: Baseline, Month 3, Month 6
measure: Change in Stress Management
timeFrame: Baseline, then monthly through Month 6
measure: Change in Weight
timeFrame: Baseline, then monthly through Month 6
measure: Change in Tobacco Use
timeFrame: Baseline, then monthly through Month 6
Other outcomes:
measure: Change in High-sensitivity C-reactive Protein (HsCRP)
timeFrame: Baseline, Month 6
measure: Change in Plasma Cysteine
timeFrame: Baseline, Month 6
measure: Change in Cystine
timeFrame: Baseline, Month 6
measure: . Change in CD34+ Cell Count
timeFrame: Baseline, Month 6
measure: Change in Pulse Wave Velocity (PWV)
timeFrame: Baseline, Month 6
measure: Change in Reactive Hyperemia Index (RHI)
timeFrame: Baseline, Month 6
measure: Change in Glutathione
timeFrame: Baseline, Month 6
measure: Change in circulating progenitor cells (CPC) CD34+/CD133+
timeFrame: Baseline, Month 6
measure: Change in circulating progenitor cells (CPCs) CD34+/VEGF2R+
timeFrame: Baseline, Month 6
measure: Change in Augmentation Index
timeFrame: Baseline, Month 6
measure: Change in Carotid Intima Media Thickness (CIMT)
timeFrame: Baseline, Month 6
Locations:
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Emory University Clinical Research Network
state: Georgia
Study officials:
affiliation: Morehouse School of Medicine
name: Herman Taylor, MD
role: STUDY_CHAIR
References: