Providing Personalized Health and Individual Lifestyle Enhancing Solutions (Prophiles) in CVD
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 1/6/2019 |
| Start Date: | February 1, 2019 |
| End Date: | December 15, 2019 |
| Contact: | Azizi Seixas |
| Email: | azizi.seixas@nyumc.org |
| Phone: | 646 501 2672 |
Providing Personalized Health and Individual Lifestyle Enhancing Solutions (Prophiles) in Cardiovascular Disease (CVD)
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).
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).
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)
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Azizi Seixas, MD
Phone: 646-501-2672
New York University School of Medicine NYU School of Medicine has a proud history that...
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