Providing Personalized Health and Individual Lifestyle Enhancing Solutions (Prophiles) in CVD
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Wedge 1- Step 1
|
Behavioral: Control Group
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.
|
| Experimental: Wedge 1-Step 2
|
Behavioral: Lifestyle Management
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
|
| Experimental: Wedge 1-Step 3
|
Behavioral: Lifestyle Management
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
|
| Experimental: Wedge 1-Step 4
|
Behavioral: Lifestyle Management
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
|
| Experimental: Wedge 1-Step 5
|
Behavioral: Lifestyle Management
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
|
| Experimental: Wedge 2- Step 1
|
Behavioral: Control Group
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.
|
| Experimental: Wedge 2-Step 2
|
Behavioral: Control Group
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.
|
| Experimental: Wedge 2-Step 3
|
Behavioral: Lifestyle Management
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
|
| Experimental: Wedge 2-Step 4
|
Behavioral: Lifestyle Management
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
|
| Experimental: Wedge 2-Step 5
|
Behavioral: Lifestyle Management
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
|
| Experimental: Wedge 3-Step 1
|
Behavioral: Control Group
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.
|
| Experimental: Wedge 3- Step 2
|
Behavioral: Control Group
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.
|
| Experimental: Wedge 3- Step 3
|
Behavioral: Control Group
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.
|
| Experimental: Wedge 3- Step 4
|
Behavioral: Lifestyle Management
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
|
| Experimental: Wedge 3- Step 5
|
Behavioral: Lifestyle Management
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
|
| Experimental: Wedge 4-Step 1
|
Behavioral: Control Group
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.
|
| Experimental: Wedge 4- Step 2
|
Behavioral: Control Group
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.
|
| Experimental: Wedge 4-Step 3
|
Behavioral: Control Group
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.
|
| Experimental: Wedge 4-Step 4
|
Behavioral: Lifestyle Management
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
|
| Experimental: Wedge 4-Step 5
|
Behavioral: Lifestyle Management
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
|
Outcome Measures
Primary Outcome Measures
- 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) [12 Months]
Used to assess physical activity and calculate metabolic equivalent
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York University School of Medicine | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: Azizi Seixas, MD, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17-01791