PREDHICT: Precision Recruitment and Engagement of Diabetics and Hypertensives in Clinical Studies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04286113|
Recruitment Status : Completed
First Posted : February 26, 2020
Last Update Posted : December 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease||Behavioral: control group Behavioral: Lifestyle management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PREDHICT: Precision Recruitment and Engagement of Diabetics and Hypertensives in Clinical Studies|
|Actual Study Start Date :||October 20, 2020|
|Actual Primary Completion Date :||October 27, 2021|
|Actual Study Completion Date :||October 27, 2021|
Active Comparator: Control group
Participants will receive non-personalized information (one-size-fits-all) diet, sleep and physical activity recommendations via messaging delivered by app.
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.
Experimental: Intervention Group
Participants will receive personalized messages about achieving healthy diet, physical activity and sleep as well as summary of their performance for the week and month. They will also receive personalized content about research volunteerism and altruistic activities.
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
- Change in clinical trials participation Change in User Adherence [ Time Frame: Baseline Visit, 4 week follow up visit, 6 month follow up visit ]Will show that one-size-fits-all versus personalization leads to greater adherence. Adherence will be based on whether the subject met the daily and weekly behavior recommendations.
- Change in glucose level Change in blood pressure [ Time Frame: Baseline Visit, 4 week follow up visit, 6 month follow up visit ]The amount of sugar levels will be determined the Harris-Benedict Calculator, which consists of height, weight, weight age and activity levels
- Change in body mass index Change in blood pressure [ Time Frame: Baseline Visit, 4 week follow up visit, 6 month follow up visit ]Change in body mass index will be determined by the self reported information the vb=vodt
- Change in physical activity [ Time Frame: Baseline Visit, 4 week follow up visit, 6 month follow up visit ]FitBit tracking will measure increase in physical activity adherence.
- Change in physical activity by self-report [ Time Frame: Baseline Visit, 4 week follow up visit, 6 month follow up visit ]Increase in physical activity will be measured by self-report diaries collected by study staff through health and wellness app platforms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04286113
|United States, New York|
|New York, New York, United States, 10016|
|Principal Investigator:||Azizi Seixas||NYU Langone|