Providing Personalized Health and Individual Lifestyle Enhancing Solutions (Prophiles) in Cardiovascular Disease (CVD)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- NYU Langone Health
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Measure of physical activity by the International Physical Activity Questionnaire (IPAQ)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The objective of the proposed project is to evaluate the usability, acceptability, and adherence of a lifestyle and behavioral self-tracking and ePersuasive tool aimed at improving: 1) adherence to diet/nutrition (<1500 mg of sodium/day and less than 10% daily free sugar intake), physical activity (PA) (150 minutes of moderate PA/week), and sleep guidelines (7-8 hours of sleep/day)-- and 2) control 3% reduction in systolic BP and glucose from baseline to end of study follow-up after 2 months (exploratory objective) in a sample of 20 patients with Hypertension or Diabetes. The study will utilize a Step-Wedge Design where the 20 patients will be divided into 4 wedges (5 patients in each wedge).
Investigators
Eligibility Criteria
Inclusion Criteria
- •NYU and/or Bellevue patient
- •Diagnosed with HTN and pre-diabetes/diabetes
- •Must be English speakers
- •Ownership of a smart phone and are willing to use it to download app built in TrialX which will be free for participants
- •Must be ambulatory
Exclusion Criteria
- •are unable or unwilling to provide informed consent;
- •are unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia);
- •are pregnant, are currently trying to become pregnant, or who become pregnant during the study
- •are institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over self-management)
- •have had or are planning to have bariatric surgery during the study
- •have a history of heart disease, kidney disease, or retinopathy (to rule-out those with long-standing, undiagnosed T2D)
Outcomes
Primary Outcomes
Measure of physical activity by the International Physical Activity Questionnaire (IPAQ)
Time Frame: 12 Months
Used to assess physical activity and calculate metabolic equivalent
User Acceptance measured by adherence to diet and nutrition using the Healthy Eating Survey
Time Frame: 12 Months