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

NYU Langone Health

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Behavioral: Lifestyle Management; Behavioral: Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03643146

17-01791

Details and patient eligibility

About

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).

Enrollment: 23 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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23 participants in 20 patient groups

Wedge 1- Step 1

Experimental group

Treatment:

Behavioral: Control Group

Wedge 1-Step 2

Experimental group

Treatment:

Behavioral: Lifestyle Management

Wedge 1-Step 3

Experimental group

Treatment:

Behavioral: Lifestyle Management

Wedge 1-Step 4

Experimental group

Treatment:

Behavioral: Lifestyle Management

Wedge 1-Step 5

Experimental group

Treatment:

Behavioral: Lifestyle Management

Wedge 2- Step 1

Experimental group

Treatment:

Behavioral: Control Group

Wedge 2-Step 2

Experimental group

Treatment:

Behavioral: Control Group

Wedge 2-Step 3

Experimental group

Treatment:

Behavioral: Lifestyle Management

Wedge 2-Step 4

Experimental group

Treatment:

Behavioral: Lifestyle Management

Wedge 2-Step 5

Experimental group

Treatment:

Behavioral: Lifestyle Management

Wedge 3-Step 1

Experimental group

Treatment:

Behavioral: Control Group

Wedge 3- Step 2

Experimental group

Treatment:

Behavioral: Control Group

Wedge 3- Step 3

Experimental group

Treatment:

Behavioral: Control Group

Wedge 3- Step 4

Experimental group

Treatment:

Behavioral: Lifestyle Management

Wedge 3- Step 5

Experimental group

Treatment:

Behavioral: Lifestyle Management

Wedge 4-Step 1

Experimental group

Treatment:

Behavioral: Control Group

Wedge 4- Step 2

Experimental group

Treatment:

Behavioral: Control Group

Wedge 4-Step 3

Experimental group

Treatment:

Behavioral: Control Group

Wedge 4-Step 4

Experimental group

Treatment:

Behavioral: Lifestyle Management

Wedge 4-Step 5

Experimental group

Treatment:

Behavioral: Lifestyle Management