Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT04791618
Status:
UNKNOWN
Last Update Posted:
2021-03-10
First Post:
2017-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MECA Clinical Intervention ( MECA Health360x)
Sponsor:
Morehouse School of Medicine
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MECAH360x
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)
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)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: