Providing Personalized Health and Individual Lifestyle Enhancing Solutions (Prophiles) in CVD
1 other identifier
interventional
23
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cardiovascular-diseases
Started Oct 2020
Shorter than P25 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2018
CompletedFirst Posted
Study publicly available on registry
August 22, 2018
CompletedStudy Start
First participant enrolled
October 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedDecember 10, 2021
December 1, 2021
5 months
August 21, 2018
December 7, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (20)
Wedge 1- Step 1
EXPERIMENTALWedge 1-Step 2
EXPERIMENTALWedge 1-Step 3
EXPERIMENTALWedge 1-Step 4
EXPERIMENTALWedge 1-Step 5
EXPERIMENTALWedge 2- Step 1
EXPERIMENTALWedge 2-Step 2
EXPERIMENTALWedge 2-Step 3
EXPERIMENTALWedge 2-Step 4
EXPERIMENTALWedge 2-Step 5
EXPERIMENTALWedge 3-Step 1
EXPERIMENTALWedge 3- Step 2
EXPERIMENTALWedge 3- Step 3
EXPERIMENTALWedge 3- Step 4
EXPERIMENTALWedge 3- Step 5
EXPERIMENTALWedge 4-Step 1
EXPERIMENTALWedge 4- Step 2
EXPERIMENTALWedge 4-Step 3
EXPERIMENTALWedge 4-Step 4
EXPERIMENTALWedge 4-Step 5
EXPERIMENTALInterventions
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Azizi Seixas, MD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2018
First Posted
August 22, 2018
Study Start
October 20, 2020
Primary Completion
March 31, 2021
Study Completion
October 1, 2021
Last Updated
December 10, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF
- Time Frame
- 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).
- Access Criteria
- Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).