Cardiovascular DiseasesNCT03643146
Providing Personalized Health and Individual Lifestyle Enhancing Solutions (Prophiles) in CVD
A study testing Lifestyle Management in people with Cardiovascular Diseases, run by NYU Langone Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Lifestyle Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Providing Personalized Health and Individual Lifestyle Enhancing Solutions (Prophiles) in Cardiovascular Disease (CVD)
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).
- Conditions
- Cardiovascular Diseases
- Being tested
- Lifestyle Management, Control Group
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ManagementBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Wedge 1- Step 1 | Experimental | Not described Receives: Behavioral: Control Group |
| Wedge 1-Step 2 | Experimental | Not described Receives: Behavioral: Lifestyle Management |
| Wedge 1-Step 3 | Experimental | Not described Receives: Behavioral: Lifestyle Management |
| Wedge 1-Step 4 | Experimental | Not described Receives: Behavioral: Lifestyle Management |
| Wedge 1-Step 5 | Experimental | Not described Receives: Behavioral: Lifestyle Management |
| Wedge 2- Step 1 | Experimental | Not described Receives: Behavioral: Control Group |
| Wedge 2-Step 2 | Experimental | Not described Receives: Behavioral: Control Group |
| Wedge 2-Step 3 | Experimental | Not described Receives: Behavioral: Lifestyle Management |
| Wedge 2-Step 4 | Experimental | Not described Receives: Behavioral: Lifestyle Management |
| Wedge 2-Step 5 | Experimental | Not described Receives: Behavioral: Lifestyle Management |
| Wedge 3-Step 1 | Experimental | Not described Receives: Behavioral: Control Group |
| Wedge 3- Step 2 | Experimental | Not described Receives: Behavioral: Control Group |
| Wedge 3- Step 3 | Experimental | Not described Receives: Behavioral: Control Group |
| Wedge 3- Step 4 | Experimental | Not described Receives: Behavioral: Lifestyle Management |
| Wedge 3- Step 5 | Experimental | Not described Receives: Behavioral: Lifestyle Management |
| Wedge 4-Step 1 | Experimental | Not described Receives: Behavioral: Control Group |
| Wedge 4- Step 2 | Experimental | Not described Receives: Behavioral: Control Group |
| Wedge 4-Step 3 | Experimental | Not described Receives: Behavioral: Control Group |
| Wedge 4-Step 4 | Experimental | Not described Receives: Behavioral: Lifestyle Management |
| Wedge 4-Step 5 | Experimental | Not described Receives: Behavioral: Lifestyle Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
User Acceptance measured by adherence to diet and nutrition using the Healthy Eating Survey
Measured: 12 Months
Measure of physical activity by the International Physical Activity Questionnaire (IPAQ)
Used to assess physical activity and calculate metabolic equivalent
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start20 Oct 2020
- Primary completion31 Mar 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Azizi Seixas, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643146
- Sponsor's protocol ID
- 17-01791
- Status last verified
- Dec 2021
- First submitted
- 21 Aug 2018
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Personalized Health and Individual Lifestyle Enhancing Solutions (Prophiles) in Cardiovascular Disease (CVD)
- ClinicalTrials.gov ID
- NCT03643146
- Acronym / sponsor ID
- 17-01791
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 20
| Arm | Type | Receives |
|---|---|---|
| Wedge 1- Step 1 | Experimental | Behavioral: Control Group |
| Wedge 1-Step 2 | Experimental | Behavioral: Lifestyle Management |
| Wedge 1-Step 3 | Experimental | Behavioral: Lifestyle Management |
| Wedge 1-Step 4 | Experimental | Behavioral: Lifestyle Management |
| Wedge 1-Step 5 | Experimental | Behavioral: Lifestyle Management |
| Wedge 2- Step 1 | Experimental | Behavioral: Control Group |
| Wedge 2-Step 2 | Experimental | Behavioral: Control Group |
| Wedge 2-Step 3 | Experimental | Behavioral: Lifestyle Management |
| Wedge 2-Step 4 | Experimental | Behavioral: Lifestyle Management |
| Wedge 2-Step 5 | Experimental | Behavioral: Lifestyle Management |
| Wedge 3-Step 1 | Experimental | Behavioral: Control Group |
| Wedge 3- Step 2 | Experimental | Behavioral: Control Group |
| Wedge 3- Step 3 | Experimental | Behavioral: Control Group |
| Wedge 3- Step 4 | Experimental | Behavioral: Lifestyle Management |
| Wedge 3- Step 5 | Experimental | Behavioral: Lifestyle Management |
| Wedge 4-Step 1 | Experimental | Behavioral: Control Group |
| Wedge 4- Step 2 | Experimental | Behavioral: Control Group |
| Wedge 4-Step 3 | Experimental | Behavioral: Control Group |
| Wedge 4-Step 4 | Experimental | Behavioral: Lifestyle Management |
| Wedge 4-Step 5 | Experimental | Behavioral: Lifestyle Management |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle ManagementWill 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 | Behavioural | Wedge 1-Step 2, Wedge 1-Step 3, Wedge 1-Step 4, Wedge 1-Step 5, Wedge 2-Step 3, Wedge 2-Step 4, Wedge 2-Step 5, Wedge 3- Step 4, Wedge 3- Step 5, Wedge 4-Step 4, Wedge 4-Step 5 |
| Control Groupwill 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. | Behavioural | Wedge 1- Step 1, Wedge 2- Step 1, Wedge 2-Step 2, Wedge 3- Step 2, Wedge 3- Step 3, Wedge 3-Step 1, Wedge 4- Step 2, Wedge 4-Step 1, Wedge 4-Step 3 |
Primary outcome
User Acceptance measured by adherence to diet and nutrition using the Healthy Eating Survey
Time frame: 12 Months
Measure of physical activity by the International Physical Activity Questionnaire (IPAQ)
Time frame: 12 Months
Used to assess physical activity and calculate metabolic equivalent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azizi Seixas, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Management in people with Cardiovascular Diseases, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User Acceptance measured by adherence to diet and nutrition using the Healthy Eating Survey (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.