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OpenTrials
Completed

NCT Number: NCT03643146

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

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lifestyle Management

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

Control Group

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.

Primary outcomes

  1. User Acceptance measured by adherence to diet and nutrition using the Healthy Eating Survey

    Time frame: 12 Months

  2. Measure of physical activity by the International Physical Activity Questionnaire (IPAQ)

    Time frame: 12 Months

    Used to assess physical activity and calculate metabolic equivalent

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 22, 2018
Registry last updated
Dec 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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