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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Morehouse School of Medicine
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Life Simple 7(LS7 the metrics for defining ideal cardiovascular health) score at 6-month follow-up
Study Overview
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"
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Health360x only (High tech) (Behavioral)
Health360x plus Coach (High tech High touch)
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
Intervention: Health360x plus health coach (Behavioral)
Health360x plus Coach (High tech High touch)
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
Intervention: Health360x only (High tech) (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Self management skills acquired(6 months)
- Change in Stress Management(Baseline, then monthly through Month 6)
- Change in Blood Glucose(Baseline, Month 3, Month 6)
- Change in Weight(Baseline, then monthly through Month 6)
- Change in Short Form-12 Health Survey Questionnaire (SF-12) score(Baseline, Month 3, 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 Tobacco Use(Baseline, then monthly through Month 6)
- Change in Systolic Blood Pressure:(Baseline, Month 6)
- Change in Distance Walked Daily(Baseline, Month 3, Month 6)
Investigators
Priscilla Pemu
Professor
Morehouse School of Medicine