An interventional study of Lifestyle Management and Control Group in Cardiovascular Diseases, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-10.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Health services research
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).
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 23 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Control Group
Behavioral: Lifestyle Management
Behavioral: Lifestyle Management
Behavioral: Lifestyle Management
Behavioral: Lifestyle Management
Behavioral: Control Group
Behavioral: Control Group
Behavioral: Lifestyle Management
Behavioral: Lifestyle Management
Behavioral: Lifestyle Management
Behavioral: Control Group
Behavioral: Control Group
Behavioral: Control Group
Behavioral: Lifestyle Management
Behavioral: Lifestyle Management
Behavioral: Control Group
Behavioral: Control Group
Behavioral: Control Group
Behavioral: Lifestyle Management
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
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.
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)
Used to assess physical activity and calculate metabolic equivalent
Time frame: 12 Months
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Icf
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NYU Langone Health