NCT03308812

Brief Summary

This study will recruit from participants in the Morehouse-Emory Cardiovascular (MECA) study for a clinical intervention examining cardiac outcomes between participants who are randomized to received Health360x (a web-based and mobile-based application) or Health360x plus personalized health coaching. Participants will receive instruction on using the Health360x application and will use Health360x alone or Health360x with a health coach for 6 months. Measures of cardiovascular health will be assessed at baseline and after the 6 month long intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable cardiovascular-diseases

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

2.5 years

First QC Date

October 9, 2017

Last Update Submit

March 24, 2020

Conditions

Cardiovascular Diseases

Keywords

Cardiovascular healthHealth coachCardiovascular risk factorsEthnic disparitiesBehavioral interventionE-health lifestyle interventionHealth360xeHealthyStrides

Outcome Measures

Primary Outcomes (1)

  • Change in Life Simple 7 (LS7) composite score

    The "Life Simple 7" (LS7) Cardiovascular Health Index is a public health metric by the American Heart Association (AHA) and is an index of modifiable health behaviors and cardiometabolic risk factors. The LS7 includes three health factors (blood pressure, fasting glucose, total cholesterol) and four health behaviors (body mass index (BMI), physical activity, healthy diet and smoking) and classifies each of them as "ideal" (score of 2), "intermediate" (score of 1) and "poor" (score of 0) levels. Total scores range from 0 to 14 and total scores between 0-4 are classified as inadequate, scores between 5-9 are considered average, and scores between 10-14 are classified as optimum cardiovascular health.

    Baseline, Month 6

Secondary Outcomes (9)

  • Change in Systolic Blood Pressure

    Baseline, Month 6

  • Change in Diastolic Blood Pressure

    Baseline, Month 6

  • Change in Delta Nutrition Intervention Research Initiative Food Frequency Questionnaire (Delta NIRI FFQ)

    Baseline, Month 6

  • Change in Blood Glucose

    Baseline, Month 3, Month 6

  • Change in Distance Walked Daily

    Baseline, Month 3, Month 6

  • +4 more secondary outcomes

Other Outcomes (11)

  • Change in High-sensitivity C-reactive Protein (HsCRP)

    Baseline, Month 6

  • Change in Plasma Cysteine

    Baseline, Month 6

  • Change in Cystine

    Baseline, Month 6

  • +8 more other outcomes

Study Arms (2)

Health360x

ACTIVE COMPARATOR

Participants will use the Health360x application for 6 months.

Behavioral: Health360x

Health360x plus health coach

EXPERIMENTAL

Participants will use the Health360x application and received personalized health coaching for 6 months.

Behavioral: Health360xBehavioral: Health Coach

Interventions

Health360xBEHAVIORAL

Participants will view an orientation video which will include information on how to access the program from home and other internet access sites, how to use their activity monitor and sphygmomanometers, introduction to the curriculum, quizzes and discussion boards. 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 application will be available 24 hours by phone.

Also known as: eHealthystrides
Health360xHealth360x plus health coach
Health CoachBEHAVIORAL

Participants will be contacted by the health coach in the first week of the study to review their initial self-management behavioral goals and approaches. Follow up calls will occur each week for the first month, biweekly for the second and third months, and then once per month for the remainder of the study (months 4-6).

Health360x plus health coach

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Already participating in the Baseline Clinical Study
  • Life Simple 7 (LS7) score of 8 or lower
  • Internet access
  • Self-reported ability to participate in physical activity
  • English fluency

You may not qualify if:

  • Coronary Artery Disease (CAD) documented by CAD diagnosis or prior acute myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, or chronic angina
  • Aortic stenosis
  • History of chronic diseases that may alter brachial artery flow-mediated vasodilation measurements, such as peripheral vascular disease, HIV/AIDS, lupus, or cancer
  • Inability to participate in increased physical activity
  • History of alcohol or drug abuse or psychiatric diagnosis that would interfere with ability to participate
  • Women who are pregnant and/or breastfeeding
  • Cognitive deficits severe enough to preclude participation or any medical or surgical problem that precludes meaningful participation
  • Unwillingness to use the internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Morehouse School of Medicine, Clinical Research Center

Atlanta, Georgia, 30310, United States

Location

Emory University Clinical Research Network

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

  • Islam SJ, Kim JH, Topel M, Liu C, Ko YA, Mujahid MS, Sims M, Mubasher M, Ejaz K, Morgan-Billingslea J, Jones K, Waller EK, Jones D, Uppal K, Dunbar SB, Pemu P, Vaccarino V, Searles CD, Baltrus P, Lewis TT, Quyyumi AA, Taylor H. Cardiovascular Risk and Resilience Among Black Adults: Rationale and Design of the MECA Study. J Am Heart Assoc. 2020 May 5;9(9):e015247. doi: 10.1161/JAHA.119.015247. Epub 2020 Apr 28.

    PMID: 32340530DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Arshed Quyyumi, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 9, 2017

First Posted

October 13, 2017

Study Start

July 25, 2017

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

US(3)