HypertensionNCT04515303
Digital Intervention Participation in DASH
An observational study of Hypertension and Dietary Quality, run by University of Connecticut at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Dietary Quality, Recruitment
- What is being tested?
- Diverse Intervention Participation in DASH
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2020to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- self-identify as having high blood pressure
- self-identify as Black/African American/Afro-Caribbean
- at least 18 years old
- self-reported body mass index≥ 18.5 kg/m2
- email address
- English is primary language
Who cannot join
- planning to leave the area during study time period
- participating in a related trial
- cardiovascular disease event (e.g. stroke, myocardial infarction) in prior 6 months
- pregnancy - current or planned during the study period
- active malignancy
- recent psychiatric institutionalization
- documented dementia
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Connecticut
Storrs, Connecticut, 06103
Loneke T. Blackman Carr, PhD, RD, 860-486-5073, loneke.blackman_carr@uconn.edu
About this study
Official title: Optimizing Inclusion of Blacks Within a Dietary Change Intervention to Reduce Hypertension
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.
Read the 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 racial/ethnic 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:
- 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.
- 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.
- 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.
- Conditions
- Hypertension, Dietary Quality, Recruitment, Cardiovascular Diseases
- Being tested
- Diverse Intervention Participation in DASH
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diverse Intervention Participation in DASHOther
A qualitative examination of barriers and facilitators of the DASH dietary pattern, and quantitative investigation of the types of recruitment methods effective for black adults entering a digital DASH-promoting intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Barriers and facilitators of recruitment
Using individual interviews to elicit information of potential recruitment preferences
Measured: day 1
Secondary outcomes (2)
Barriers and facilitators of diet quality
Individual interviews to understand black men/women's diet quality experiences
Measured: day 1
Comparison of recruitment methods
Use recruitment data collected from the main trial to compare the most effective recruitment methods for black men and women
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start9 Sep 2020
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Loneke T. Blackman Carr, PhD, RD, University of Connecticut
- Investigators
- Loneke Blackman Carr, PhD, RD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515303
- Sponsor's protocol ID
- KFS 5658780
- Other IDs
- 3R01HL146768-01S1
- Status last verified
- Apr 2021
- First submitted
- 12 Aug 2020
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Inclusion of Blacks Within a Dietary Change Intervention to Reduce Hypertension
- ClinicalTrials.gov ID
- NCT04515303
- Acronym / sponsor ID
- KFS 5658780
- Conditions
- Hypertension, Dietary Quality, Recruitment, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- Duke University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 racial/ethnic 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:
- 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.
- 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.
- 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (6 listed)
- self-identify as having high blood pressure
- self-identify as Black/African American/Afro-Caribbean
- at least 18 years old
- self-reported body mass index≥ 18.5 kg/m2
- email address
Key exclusion criteria (7 listed)
- planning to leave the area during study time period
- participating in a related trial
- cardiovascular disease event (e.g. stroke, myocardial infarction) in prior 6 months
- pregnancy - current or planned during the study period
- active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diverse Intervention Participation in DASHA qualitative examination of barriers and facilitators of the DASH dietary pattern, and quantitative investigation of the types of recruitment methods effective for black adults entering a digital DASH-promoting intervention. | Other | – |
Primary outcome
Barriers and facilitators of recruitment
Time frame: day 1
Using individual interviews to elicit information of potential recruitment preferences
2 secondary outcomes
Barriers and facilitators of diet quality
Time frame: day 1
Comparison of recruitment methods
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loneke Blackman Carr, PhD, RD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Dietary Quality, run by University of Connecticut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Loneke Blackman Carr, PhD, RD (860-486-5073, Loneke.blackman_carr@uconn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barriers and facilitators of recruitment (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.