Cardiovascular Diseases
Conditions
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).
Interventions
BEHAVIORALLifestyle 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
BEHAVIORALControl 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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 12 Months | Used to assess physical activity and calculate metabolic equivalent |
Countries
United States
Outcome results
None listed