Cardiovascular HealthMECAH360xNCT04791618
MECA Clinical Intervention ( MECA Health360x)
A study testing Health360x plus health coach and Health360x only (High tech) in people with Cardiovascular Health and Self-management, run by Morehouse School of Medicine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health, Self-management
- What is being tested?
- Health360x plus health coach and Health360x only (High tech)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Morehouse School of Medicine
Atlanta, Georgia, 30310
Emory University Clinical Research Network
Atlanta, Georgia, 30322
About this study
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
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.
Read the 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"
- 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
- Investigators will email participants enrollment and welcome package that contains links to the
- Online screening form
- Consent form Please complete both forms
- 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
- Investigators will have Live chat sessions to answer questions about the project by the health coach and PI. Participants can access these as needed
- 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
- Self- assessment; LS7 score
- Participant will receive a sleep/activity tracker; Investigators will work to obtain a Blood Pressure monitor through participants' usual health insurance
- 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)
- 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)
- 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)
- Conditions
- Cardiovascular Health, Self-management
- Being tested
- Health360x plus health coach, Health360x only (High tech)
- 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
- Medical subject headings
- Hypertension, Obesity, Diabetes Mellitus, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health360x plus health coachBehavioural
Also called Health coach intervention, Self management skills training, Goal setting, Monitoring
Access to health360x which provides monitoring, in the moment color coded feedback and goal setting for self management skills
Health360x only (High tech)Behavioural
Also called e-Health lifestyle intervention, Self management skills training, Goal setting, Monitoring
All participants will have access to Helath360x with reminders generated for goal setting.
| Study group | Role | What they receive |
|---|---|---|
| Health360x only (High tech) | Active comparator | Access to Health360x technology only for 6 months Behavioral: Health360x Participants will receive Access to health360x which provides monitoring, in the moment color coded feedback and goal setting for self- management skills. Every participant will view an orientation video which will include information on how to access Health360 from home and other internet connected devices; how to use activity monitors provided by the study and sphygmomanometer. They will receive an introduction to heart health curriculum, quizzes and discussion forums. Participants will be encouraged to upload their data at least once a week and to access the curriculum as often as desired. Technological and customer service support related to use of the Helath360x application will be available online and by phone.
The Health360x application will send messages to participants in this arm reminding them to perform study related activities. Receives: Behavioral: Health360x only (High tech) |
| Health360x plus Coach (High tech High touch) | Experimental | Health360x technology plus health coach Behavioral: Health360x plus health coach Participants will receive all of the resources in Arm A and Health coach interactions.
The Health coach will send messages to participants in this arm reminding them to perform study related activities. The coach interactions will be focused on helping with attainment of self- management behaviors Receives: Behavioral: Health360x plus health coach; Behavioral: Health360x only (High tech) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life Simple 7(LS7 the metrics for defining ideal cardiovascular health) score at 6-month follow-up
The LS7 score consists of 4 behavioral and 3 clinical measures. The behavioral measures are smoking, body Mass Index (BMI), physical activity and healthy dietary pattern. The clinical measures are blood pressure, total cholesterol and fasting plasma glucose.Each LS7 component will be given a point score of 0, 1, or 2 to represent poor, intermediate, or ideal health, respectively. Then, an overall LS7 score ranging from 0 to 14 will be calculated as the sum of the LS7 component scores. The overall LS7 score will be further classified as inadequate (0-4), average (5-9), or optimum (10-14) cardiovascular health.
Measured: 6 months
Secondary outcomes (10)
Self management skills acquired
Self management skills are patterned on the AADE 7 self care behaviors. A skill is acquired when the participant reports a score of 7 or higher on a 10-point scale.
Healthy Coping Healthy Eating Being Active Monitoring Taking Medication Problem Solving Reducing Risks
Measured: 6 months
Change in Systolic Blood Pressure:
Blood pressure readings will be made three times with the subject at rest in the sitting position using a cuff of the appropriate size and a standardized procedure. The average of the three systolic blood pressure measurements will be calculated. Blood pressure will be categorized according to Joint National Committee recommendations.
Measured: Baseline, Month 6
Change in Diastolic Blood Pressure
Blood pressure readings will be made three times with the subject at rest in the sitting position using a cuff of the appropriate size and a standardized procedure. The average of the three diastolic blood pressure measurements will be calculated. Blood pressure will be categorized according to Joint National Committee recommendations.
Measured: Baseline, Month 6
Change in Delta Nutrition Intervention Research Initiative Food Frequency Questionnaire (Delta NIRI FFQ)
Dietary intake of fruits and vegetables will be assessed using the Lower Mississippi Delta Nutrition Intervention Research Initiative food frequency questionnaire (Delta NIRI FFQ). The Delta NIRI FFQ is a 283-item, interviewer administered questionnaire that asks if respondents have had certain food items in the past 24 hours, including foods that are commonly consumed in the southern United States.
Measured: Baseline, Month 6
Change in Blood Glucose
Blood glucose will be measured as milligrams per deciliter at Baseline, 3 months after the start of the intervention and at the end of the intervention at month 6. Normal, fasting blood glucose levels are between 70 to 100 mg/dL.
Measured: Baseline, Month 3, Month 6
Change in Distance Walked Daily
The total distance walked daily in miles will be measured by a pedometer or the exercise application for mobile devices.
Measured: Baseline, Month 3, Month 6
Change in Short Form-12 Health Survey Questionnaire (SF-12) score
The Short Form-12 Health Survey Questionnaire (SF-12) is a measure of general physical and mental health.
The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. The total score for each subscale ranges from 0 to 100 and low values represent a poor health state while high values represent a good health state.
Measured: Baseline, Month 3, Month 6
Change in Stress Management
Participants will report on their stress management monthly via free text responses in an online format.
Measured: Baseline, then monthly through Month 6
Change in Weight
Participants will report their weight in pounds once per month during the intervention period.
Measured: Baseline, then monthly through Month 6
Change in Tobacco Use
Participants will report whether or not they have used tobacco once per month during the intervention period.
Measured: Baseline, then monthly through Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 May 2017
- Primary completion30 Sep 2020
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morehouse School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Principal investigator, Priscilla Pemu, Morehouse School of Medicine
- Investigators
- Herman Taylor, MD, Study chair, Morehouse School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791618
- Sponsor's protocol ID
- 809392
- Acronym
- MECAH360x
- Status last verified
- Mar 2021
- First submitted
- 9 Oct 2017
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04791618
- Acronym / sponsor ID
- MECAH360x / 809392
- Conditions
- Cardiovascular Health, Self-management
- Keywords
- Cardiovascular health risk, e-health lifestyle intervention, ehealthystrides, Life simple 7, Health coach, Health equity, Behavioral intervention, Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Morehouse School of MedicineUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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"
- 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
- Investigators will email participants enrollment and welcome package that contains links to the
- Online screening form
- Consent form Please complete both forms
- 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
- Investigators will have Live chat sessions to answer questions about the project by the health coach and PI. Participants can access these as needed
- 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
- Self- assessment; LS7 score
- Participant will receive a sleep/activity tracker; Investigators will work to obtain a Blood Pressure monitor through participants' usual health insurance
- 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)
- 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)
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health360x only (High tech) | Active comparator | Behavioral: Health360x only (High tech)Access to Health360x technology only for 6 months Behavioral: Health360x Participants will receive Access to health360x which provides monitoring, in the moment color coded feedback and goal setting for self- management skills. Every participant will view an orientation video which will include information on how to access Health360 from home and other internet connected devices; how to use activity monitors provided by the study and sphygmomanometer. They will receive an introduction to heart health curriculum, quizzes and discussion forums. Participants will be encouraged to upload their data at least once a week and to access the curriculum as often as desired. Technological and customer service support related to use of the Helath360x application will be available online and by phone. The Health360x application will send messages to participants in this arm reminding them to perform study related activities. |
| Health360x plus Coach (High tech High touch) | Experimental | Behavioral: Health360x plus health coach, Behavioral: Health360x only (High tech)Health360x technology plus health coach Behavioral: Health360x plus health coach Participants will receive all of the resources in Arm A and Health coach interactions. The Health coach will send messages to participants in this arm reminding them to perform study related activities. The coach interactions will be focused on helping with attainment of self- management behaviors |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health360x plus health coachAlso: Health coach intervention, Self management skills training, Goal setting, MonitoringAccess to health360x which provides monitoring, in the moment color coded feedback and goal setting for self management skills | Behavioural | Health360x plus Coach (High tech High touch) |
| Health360x only (High tech)Also: e-Health lifestyle intervention, Self management skills training, Goal setting, MonitoringAll participants will have access to Helath360x with reminders generated for goal setting. | Behavioural | Health360x only (High tech), Health360x plus Coach (High tech High touch) |
Primary outcome
Life Simple 7(LS7 the metrics for defining ideal cardiovascular health) score at 6-month follow-up
Time frame: 6 months
The LS7 score consists of 4 behavioral and 3 clinical measures. The behavioral measures are smoking, body Mass Index (BMI), physical activity and healthy dietary pattern. The clinical measures are blood pressure, total cholesterol and fasting plasma glucose.Each LS7 component will be given a point score of 0, 1, or 2 to represent poor, intermediate, or ideal health, respectively. Then, an overall LS7 score ranging from 0 to 14 will be calculated as the sum of the LS7 component scores. The overall LS7 score will be further classified as inadequate (0-4), average (5-9), or optimum (10-14) cardiovascular health.
10 secondary outcomes
Self management skills acquired
Time frame: 6 months
Change in Systolic Blood Pressure:
Time frame: Baseline, Month 6
Change in Diastolic Blood Pressure
Time frame: Baseline, Month 6
Change in Delta Nutrition Intervention Research Initiative Food Frequency Questionnaire (Delta NIRI FFQ)
Time frame: Baseline, Month 6
Change in Blood Glucose
Time frame: Baseline, Month 3, Month 6
Change in Distance Walked Daily
Time frame: Baseline, Month 3, Month 6
Change in Short Form-12 Health Survey Questionnaire (SF-12) score
Time frame: Baseline, Month 3, Month 6
Change in Stress Management
Time frame: Baseline, then monthly through Month 6
Change in Weight
Time frame: Baseline, then monthly through Month 6
Change in Tobacco Use
Time frame: Baseline, then monthly through Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herman Taylor, MD study chair
Morehouse School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health360x plus health coach and Health360x only (High tech) in people with Cardiovascular Health and Self-management, run by Morehouse School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life Simple 7(LS7 the metrics for defining ideal cardiovascular health) score at 6-month follow-up (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021; AzTrials last refreshed its copy on 6 Nov 2026.