Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04515303
Status:
UNKNOWN
Last Update Posted:
2021-04-27
First Post:
2020-08-12
Brief Title:
Digital Intervention Participation in DASH
Sponsor:
University of Connecticut
Organization:
University of Connecticut
Study Overview
Official Title:
Optimizing Inclusion of Blacks Within a Dietary Change Intervention to Reduce Hypertension
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the context of making high quality dietary choices among Black adults with hypertension Secondly this study will also investigate what Black adults need or desire to participate in a digital intervention to improve dietary quality by adopting the DASH eating pattern
Detailed Description:
Nearly 50 of adults in the United States have high blood pressure a leading contributor to cardiovascular disease When race is considered the majority of black adults 55 have high blood pressure a greater prevalence than other racialethnic groups The elevated rate of high blood pressure a diet-related disease reflects the sub-optimal diet quality observed in blacks The DASH dietary pattern is an evidence-based strategy to treat high blood pressure that has become part of the Dietary Guidelines for Americans DASH promotes a diet rich in fruits and vegetables low-fat dairy controlled amounts of total fat cholesterol and saturated fat high fiber and protein content Data from the National Health and Nutrition Examination Survey indicate that approximately 19 of adults with high blood pressure were DASH adherent Those who were adherent tended to be older and non-black with a higher education level Even after intervention lower DASH adherence scores have been seen in blacks versus whites possibly due to lower baseline consumption of DASH foods in blacks Although dietary improvements from DASH-promoting interventions have been observed adherence has decreased over time and when translated to less controlled settings Sufficient representation of blacks is important for clinical trials testing DASH given the disproportionate prevalence of high blood pressure This study will examine factors that may influence black adults participation and success in improving dietary quality through the following aims
1 To identify barriers to and facilitators of recruiting black adults into a digital DASH-promoting intervention A semi-structured interview guide will direct individual interviews via phone with black men and women to understand what supports or deters participation in a digital health intervention trial for dietary quality improvement
2 To determine the barriers and facilitators to improving dietary quality in black adults
Participants in the individual interviews Aim 1 will also identify their motivations concerns and priorities surrounding dietary change This will inform recruitment efforts and our understanding about how to improve dietary quality
3 To conduct secondary data analyses to determine the effectiveness by race and gender group of various recruitment methods from a 12-month randomized controlled trial to examine the effects of the intervention on changes in dietary quality and blood pressure among men and women with high blood pressure clinical trails identifier NCT03875768 The intervention asks participants to track their diet daily using a common commercial tracking app with an extensive nutrient database via smartphone Food and nutrient data from the app is processed using an application programming interface compared against an algorithm and generates personalized automated text messages to each participant with information on DASH diet adherence and diet tips Responsive coaching is also included for participants that require greater support for dietary change
Diverse sample recruitment is essential to producing outcomes that are applicable to diverse populations living with hypertension Examination of barriers and facilitators to consuming a quality diet and identification of effective recruitment methods for digital interventions may inform how investigators reach black men and women with hypertension to effectively improve diet for the treatment of cardiovascular disease
1 To identify barriers to and facilitators of recruiting black adults into a digital DASH-promoting intervention A semi-structured interview guide will direct individual interviews via phone with black men and women to understand what supports or deters participation in a digital health intervention trial for dietary quality improvement
2 To determine the barriers and facilitators to improving dietary quality in black adults
Participants in the individual interviews Aim 1 will also identify their motivations concerns and priorities surrounding dietary change This will inform recruitment efforts and our understanding about how to improve dietary quality
3 To conduct secondary data analyses to determine the effectiveness by race and gender group of various recruitment methods from a 12-month randomized controlled trial to examine the effects of the intervention on changes in dietary quality and blood pressure among men and women with high blood pressure clinical trails identifier NCT03875768 The intervention asks participants to track their diet daily using a common commercial tracking app with an extensive nutrient database via smartphone Food and nutrient data from the app is processed using an application programming interface compared against an algorithm and generates personalized automated text messages to each participant with information on DASH diet adherence and diet tips Responsive coaching is also included for participants that require greater support for dietary change
Diverse sample recruitment is essential to producing outcomes that are applicable to diverse populations living with hypertension Examination of barriers and facilitators to consuming a quality diet and identification of effective recruitment methods for digital interventions may inform how investigators reach black men and women with hypertension to effectively improve diet for the treatment of cardiovascular disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3R01HL146768-01S1 | NIH | None | httpsreporternihgovquickSearch3R01HL146768-01S1 |