NCT04791618

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

May 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

3.4 years

First QC Date

October 9, 2017

Last Update Submit

March 9, 2021

Conditions

Cardiovascular HealthSelf-management

Keywords

Cardiovascular health riske-health lifestyle interventionehealthystridesLife simple 7Health coachHealth equityBehavioral interventionHypertensionObesityDiabetes MellitusHelath360xTobacco use

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (10)

  • Self management skills acquired

    6 months

  • 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

  • +5 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 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.

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

Behavioral: Health360x plus health coachBehavioral: Health360x only (High tech)

Interventions

Health360x plus health coachBEHAVIORAL

Access to health360x which provides monitoring, in the moment color coded feedback and goal setting for self management skills

Also known as: Health coach intervention, Self management skills training, Goal setting, Monitoring, Healthy coping
Health360x plus Coach (High tech High touch)
Health360x only (High tech)BEHAVIORAL

All participants will have access to Helath360x with reminders generated for goal setting.

Also known as: e-Health lifestyle intervention, Self management skills training, Goal setting, Monitoring, Healthy coping
Health360x only (High tech)Health360x plus Coach (High tech High touch)

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location

Emory University Clinical Research Network

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

HypertensionObesityDiabetes MellitusTobacco Use

Interventions

Organizational Objectives

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Organization and AdministrationHealth Services Administration

Study Officials

  • Herman Taylor, MD

    Morehouse School of Medicine

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

October 9, 2017

First Posted

March 10, 2021

Study Start

May 1, 2017

Primary Completion

September 30, 2020

Study Completion

December 31, 2021

Last Updated

March 10, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)