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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03643146
• Other study ID #: 17-01791
• Status: Completed
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: December 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 1, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	User Acceptance measured by adherence to diet and nutrition using the Healthy Eating Survey		12 Months
Primary	Measure of physical activity by the International Physical Activity Questionnaire (IPAQ)	Used to assess physical activity and calculate metabolic equivalent	12 Months