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

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Behavioral: Lifestyle Management; Behavioral: Control Group

• Registration Number: NCT03643146
• Lead Sponsor: NYU Langone Health

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-22
• Study Start: 2020-10-20
• Primary Completion: 2021-03-31
• Study Completion: 2021-10-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Wedge 1-Step 4	Lifestyle Management	-
Wedge 3- Step 3	Control Group	-
Wedge 3- Step 4	Lifestyle Management	-
Wedge 1- Step 1	Control Group	-
Wedge 1-Step 5	Lifestyle Management	-
Wedge 2- Step 1	Control Group	-
Wedge 2-Step 2	Control Group	-
Wedge 2-Step 3	Lifestyle Management	-
Wedge 3- Step 2	Control Group	-
Wedge 1-Step 2	Lifestyle Management	-
Wedge 1-Step 3	Lifestyle Management	-
Wedge 2-Step 4	Lifestyle Management	-
Wedge 3-Step 1	Control Group	-
Wedge 3- Step 5	Lifestyle Management	-
Wedge 4-Step 3	Control Group	-
Wedge 2-Step 5	Lifestyle Management	-
Wedge 4-Step 1	Control Group	-
Wedge 4- Step 2	Control Group	-
Wedge 4-Step 4	Lifestyle Management	-
Wedge 4-Step 5	Lifestyle Management	-

Primary Outcome Measures

Name	Time	Method
Measure of physical activity by the International Physical Activity Questionnaire (IPAQ)	12 Months	Used to assess physical activity and calculate metabolic equivalent
User Acceptance measured by adherence to diet and nutrition using the Healthy Eating Survey	12 Months

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States