Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wedge 1- Step 1 | Experimental |
| |
| Wedge 1-Step 2 | Experimental |
| |
| Wedge 1-Step 3 | Experimental |
| |
| Wedge 1-Step 4 | Experimental |
| |
| Wedge 1-Step 5 | Experimental |
| |
| Wedge 2- Step 1 | Experimental |
| |
| Wedge 2-Step 2 | Experimental |
| |
| Wedge 2-Step 3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Management | Behavioral | Will use passive ubiquitous sensing through FitBit to 1)learn behavioral profiles of subjects who have pre-HTN/HTN and/or pre-diabetes /Diabetes 2) provide personalized recommendations through mobile based messaging app that will increase the likelihood of engaging in health diet/nutrition, physical activity and sleep practices |
| Measure | Description | Time Frame |
|---|---|---|
| User Acceptance measured by adherence to diet and nutrition using the Healthy Eating Survey | 12 Months | |
| Measure of physical activity by the International Physical Activity Questionnaire (IPAQ) | Used to assess physical activity and calculate metabolic equivalent | 12 Months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Azizi Seixas, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting requests and accessing data may be found at (Link to be provided).
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
Not provided
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Wedge 2-Step 4 | Experimental |
|
| Wedge 2-Step 5 | Experimental |
|
| Wedge 3-Step 1 | Experimental |
|
| Wedge 3- Step 2 | Experimental |
|
| Wedge 3- Step 3 | Experimental |
|
| Wedge 3- Step 4 | Experimental |
|
| Wedge 3- Step 5 | Experimental |
|
| Wedge 4-Step 1 | Experimental |
|
| Wedge 4- Step 2 | Experimental |
|
| Wedge 4-Step 3 | Experimental |
|
| Wedge 4-Step 4 | Experimental |
|
| Wedge 4-Step 5 | Experimental |
|
|
| Control Group | Behavioral | will receive standard medical care where research assistant will give pamphlets, with one size fits all recommendations for diet/nutrition, physical activity and sleep, to 10 subjects with comorbid HTN and T2D. |
|
| D008722 | Methods |