Providing Personalized Health and Individual Lifestyle Enhancing Solutions (Prophiles) in CVD

Study Overview
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Brief Summary
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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).

Official Title
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Providing Personalized Health and Individual Lifestyle Enhancing Solutions (Prophiles) in Cardiovascular Disease (CVD)

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Lifestyle Management
* Behavioral: Control Group


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wedge 1- Step 1<br> | Behavioral: Control Group<br>* 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.<br>|
| Experimental: Wedge 1-Step 2<br> | Behavioral: Lifestyle Management<br>* 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<br>|
| Experimental: Wedge 1-Step 3<br> | Behavioral: Lifestyle Management<br>* 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<br>|
| Experimental: Wedge 1-Step 4<br> | Behavioral: Lifestyle Management<br>* 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<br>|
| Experimental: Wedge 1-Step 5<br> | Behavioral: Lifestyle Management<br>* 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<br>|
| Experimental: Wedge 2- Step 1<br> | Behavioral: Control Group<br>* 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.<br>|
| Experimental: Wedge 2-Step 2<br> | Behavioral: Control Group<br>* 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.<br>|
| Experimental: Wedge 2-Step 3<br> | Behavioral: Lifestyle Management<br>* 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<br>|
| Experimental: Wedge 2-Step 4<br> | Behavioral: Lifestyle Management<br>* 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<br>|
| Experimental: Wedge 2-Step 5<br> | Behavioral: Lifestyle Management<br>* 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<br>|
| Experimental: Wedge 3-Step 1<br> | Behavioral: Control Group<br>* 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.<br>|
| Experimental: Wedge 3- Step 2<br> | Behavioral: Control Group<br>* 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.<br>|
| Experimental: Wedge 3- Step 3<br> | Behavioral: Control Group<br>* 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.<br>|
| Experimental: Wedge 3- Step 4<br> | Behavioral: Lifestyle Management<br>* 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<br>|
| Experimental: Wedge 3- Step 5<br> | Behavioral: Lifestyle Management<br>* 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<br>|
| Experimental: Wedge 4-Step 1<br> | Behavioral: Control Group<br>* 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.<br>|
| Experimental: Wedge 4- Step 2<br> | Behavioral: Control Group<br>* 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.<br>|
| Experimental: Wedge 4-Step 3<br> | Behavioral: Control Group<br>* 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.<br>|
| Experimental: Wedge 4-Step 4<br> | Behavioral: Lifestyle Management<br>* 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<br>|
| Experimental: Wedge 4-Step 5<br> | Behavioral: Lifestyle Management<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |