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

NCT ID: NCT03643146

Last Updated: 2021-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2021-10-01

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).

Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Wedge 1- Step 1

Group Type EXPERIMENTAL

Control Group

Intervention Type BEHAVIORAL

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.

Wedge 1-Step 2

Group Type EXPERIMENTAL

Lifestyle Management

Intervention Type BEHAVIORAL

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

Wedge 1-Step 3

Group Type EXPERIMENTAL

Lifestyle Management

Intervention Type BEHAVIORAL

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

Wedge 1-Step 4

Group Type EXPERIMENTAL

Lifestyle Management

Intervention Type BEHAVIORAL

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

Wedge 1-Step 5

Group Type EXPERIMENTAL

Lifestyle Management

Intervention Type BEHAVIORAL

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

Wedge 2- Step 1

Group Type EXPERIMENTAL

Control Group

Intervention Type BEHAVIORAL

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.

Wedge 2-Step 2

Group Type EXPERIMENTAL

Control Group

Intervention Type BEHAVIORAL

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.

Wedge 2-Step 3

Group Type EXPERIMENTAL

Lifestyle Management

Intervention Type BEHAVIORAL

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

Wedge 2-Step 4

Group Type EXPERIMENTAL

Lifestyle Management

Intervention Type BEHAVIORAL

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

Wedge 2-Step 5

Group Type EXPERIMENTAL

Lifestyle Management

Intervention Type BEHAVIORAL

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

Wedge 3-Step 1

Group Type EXPERIMENTAL

Control Group

Intervention Type BEHAVIORAL

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.

Wedge 3- Step 2

Group Type EXPERIMENTAL

Control Group

Intervention Type BEHAVIORAL

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.

Wedge 3- Step 3

Group Type EXPERIMENTAL

Control Group

Intervention Type BEHAVIORAL

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.

Wedge 3- Step 4

Group Type EXPERIMENTAL

Lifestyle Management

Intervention Type BEHAVIORAL

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

Wedge 3- Step 5

Group Type EXPERIMENTAL

Lifestyle Management

Intervention Type BEHAVIORAL

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

Wedge 4-Step 1

Group Type EXPERIMENTAL

Control Group

Intervention Type BEHAVIORAL

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.

Wedge 4- Step 2

Group Type EXPERIMENTAL

Control Group

Intervention Type BEHAVIORAL

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.

Wedge 4-Step 3

Group Type EXPERIMENTAL

Control Group

Intervention Type BEHAVIORAL

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.

Wedge 4-Step 4

Group Type EXPERIMENTAL

Lifestyle Management

Intervention Type BEHAVIORAL

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

Wedge 4-Step 5

Group Type EXPERIMENTAL

Lifestyle Management

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Azizi Seixas, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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17-01791

Identifier Type: -

Identifier Source: org_study_id