HypertensionNCT03993808
DASH Diet Intervention at Senior Centers
A study testing Revision of congregate meal menus and recipes to align with parameters of DASH eating plan, On-site blood pressure monitoring and Home self blood pressure monitoring in people with Hypertension, run by Rockefeller University at 1 site in United States.
Trial summary
The Carter Burden Network (CBN) is an New York City senior services agency, providing vital meal programs for low-income, minority seniors, age 60 and over. In 2016, CBN formed a community-academic partnership with The Rockefeller University (RU) and Clinical Directors Network (CDN) to conduct a Healthy Aging pilot… Read more about this study
- Who is it for?
- Ages 60 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Revision of congregate meal menus and recipes to align with parameters of DASH eating plan, On-site blood pressure monitoring and Home self blood pressure monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2019to 14 Oct 2020
- Phase
- Interventional
- 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 60 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A client of the Carter Burden Leonard Covello Senior Center, or the 74th Street Luncheon Club, consuming one or more meals at the center, 4 or more days a week, for at least 3 months, by self report.
- Fluent in English or Spanish
- Currently planning to continue to receive meals at the CBN site (Leonard Covello or Luncheon Club) for the next 6 months
Who cannot join
- A diagnosis of dementia, early dementia or other cognitive impairment reported by the study participant, the participant's caregiver, CBN staff, or the study team.
- Any condition, that in the opinion of the person obtaining consent, would interfere with the individual's ability to complete the assessments.
- Individuals who rely on a Legal Authorized Representative (LAR)
- Anticipated absence of more than a week, between enrollment and the 1 Month time point
Trial locations and contacts
1 site in 1 country.
United States1 site
Carter Burden Network Leonard Covello Center
New York, New York, 10029
About this study
Official title: Improving Cardiovascular Health Through Implementation of a Dietary Approaches to Stop Hypertension (DASH)-Diet-based Multi-component Intervention With Senior Services Programs
The Carter Burden Network (CBN) is an New York City senior services agency, providing vital meal programs for low-income, minority seniors, age 60 and over. In 2016, CBN formed a community-academic partnership with The Rockefeller University (RU) and Clinical Directors Network (CDN) to conduct a Healthy Aging pilot study and found that 84% of participants had high blood pressure, with up to 27% "uncontrolled" using age-adjusted criteria. High blood pressure is a modifiable risk for cardiovascular disease, and has been readily improved in controlled trials by replacement of a typical Western diet with the Dietary Approaches to Stop Hypertension (DASH) diet. The DASH diet has been proven to meaningfully reduce blood pressure in as little as 14 days. However, the DASH diet has not been tested in seniors, in the setting of senior centers. Many seniors attending CBN centers receive close to 40% of their daily nutrition through congregate meals served there. This study tests the effectiveness of implementing the DASH-diet through modification of congregate meals at CBN senior centers to align with DASH, while providing educational and behavioral support, including home self-monitoring of blood pressure, to improve self-efficacy related to blood pressure management. The primary outcome is the change in systolic blood pressure.
Read the detailed description
The Carter Burden Network (CBN) is an New York City senior services agency, providing vital meal programs for low-income, minority seniors, age 60 and over. Its four senior centers serve 300,000 meals annually through congregate breakfasts and lunches, and home-delivered meals. In 2016, CBN formed a community-academic partnership with The Rockefeller University (RU) and Clinical Directors Network (CDN) to conduct a Healthy Aging pilot study at two of its East Harlem sites, finding that 84% of participants had high blood pressure, with up to 27% "uncontrolled" by age-adjusted criteria. Hypertension continues to be a significant, modifiable, but poorly-controlled contributor to morbidity and mortality from cardiovascular disease (CVD), contributing to stroke, heart attack, renal failure, and cognitive decline, increasing healthcare costs and causing loss of function, independence, and quality of life. Replacement of a typical Western diet with the Dietary Approaches to Stop Hypertension (DASH) diet has been proven to reduce blood pressure in i hypertensive individuals, and individuals with normal blood pressure in as little as 14 days. However, approaches to effective implementation of the DASH diet are untested in community-living seniors.
To address the high cardiovascular risk of uncontrolled hypertension among seniors and introduce innovation into its nutritional program, CBN, RU and CDN designed this two year project to test a DASH-diet-based multi-component intervention to lower blood pressure in two of its senior centers, serving low-income and/or minority seniors. The intervention includes health education, participant input into menu design, redesign of current congregate meals menus to make them with DASH-aligned menus, and home-self monitoring of blood pressure with educational and social support. The primary outcome will be the change in mean systolic blood pressure, measured by health professionals one month after full DASH implementation, compared to baseline. Secondary outcomes include the change in the percentage of seniors with blood pressure in the range of "controlled" by Joint National Committee 8 (JNC-8) guidelines, and the change in blood pressure at three months and at six months.
To optimize acceptance of the changes to menu and recipes, clients will be engaged and provide feedback during the design, implementation and conduct phases of the study. Dietary changes will be planned to incorporate client preferences. Clients will provide feedback weekly on menu acceptability referencing a simple smiley face Likert scale. Educational programs will consist of a series of sessions covering nutritional education including recipes and cooking demonstrations, blood pressure information and training in home self-monitoring with a study-provided blue-tooth enabled Omron 10 device, and information to enhance medication adherence. Participants will have pulse, blood pressure, weight, and behavioral aspects of self-efficacy assessed at baseline, and at Months 1, 3, and 6 of after DASH implementation. Surveys to assess quality of life, food frequency (for compliance with DASH-aligned eating outside of congregate meals), menu satisfaction, medication adherence, and other risks relevant to blood pressure management will be assessed at the same Month 0,1,3,6 time points).
- Conditions
- Hypertension
- Being tested
- Revision of congregate meal menus and recipes to align with parameters of DASH eating plan, On-site blood pressure monitoring, Home self blood pressure monitoring, Medical adherence education, Nutrition Education
- Keywords
- Nutrition, micro-nutrients, implementation, food insecurity
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revision of congregate meal menus and recipes to align with parameters of DASH eating planBehavioural
Also called DASH diet
On a programmatic level, congregate meal menus and recipes have been adapted to align with DASH eating. The changes, which include the introduction of additional servings of fruits, vegetables, seeds, grains, replacement of simple or processed carbohydrates with healthier alternatives, introduction of more fish, reduction in added salt, and replacement of animal fats and butter with olive oil, will be phased-in in stages over 6 weeks, concurrent with the start up the study's educational programs addressing nutrition, BP, and medication adherence. The fully DASH-aligned menus will begin by week 7. The dietary intervention affects all seniors eating congregate meals at the center, not only those enrolled in this protocol to study the impact of DASH implementation.
On-site blood pressure monitoringBehavioural
At baseline (Month 0), and at Months 1, 3, and 6 after the full implementation of the DASH aligned congregate meals, participants will have blood pressure measured by professionals, on-site at the senior center, following established standard procedures. They will receive verbal and written information about their blood pressure results, and encouragement to share the results with their providers.
Home self blood pressure monitoringBehavioural
Also called self-measured blood pressure monitoring (SMBP)
Provision of personal Omron 10 home blood pressure monitoring device, training in proper use, and schedule for home self monitoring of BP over the course of the study.
Medical adherence educationBehavioural
One required educational session with the community pharmacist to learn about medication adherence strategies
Nutrition EducationBehavioural
One required educational session to review the elements of the DASH eating plan, how to overcome barriers to healthy eating, recipes, cooking demonstrations and materials for household members.
| Study group | Role | What they receive |
|---|---|---|
| Educational/behavioral support for hypertension self efficacy | Experimental | On-site monitoring of pulse, blood pressure, weight, and surveys, at Months 0,1,3,6; Four educational sessions to address: 1) basics about blood pressure (BP); 2) training in home BP monitoring with personal Omron 10 device; 3) information about Dietary Intervention to lower Systemic Blood Pressure (DASH) eating plan, recipes and cooking demonstrations; 4) education about BP medication adherence. Interventions occur on the background of Carter Burden Network's implementation of a DASH-congruent menus for congregant meals for all seniors attending the sites, including those not enrolled in the protocol. Receives: Behavioral: Revision of congregate meal menus and recipes to align with parameters of DASH eating plan; Behavioral: On-site blood pressure monitoring; Behavioral: Home self blood pressure monitoring; Behavioral: Medical adherence education; Behavioral: Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure
Change in the mean of clients' systolic blood pressure measured at on-site assessments, reported in millimeters of Mercury (mm Hg).
Measured: One month after implementation of the DASH-aligned congregate meals, compared to Baseline measurement (Month 0) before implementation of dietary or behavioral interventions
Change in Proportion of individuals with Blood Pressure is in the "controlled" range
The proportion of individuals who blood pressure is within the range "controlled" according to 8th Joint National Committee (JNC-8) guidelines, which for individuals age >60 years, is systolic blood pressure <150 mm Hg, and diastolic blood pressure <90 mm Hg.
Measured: One month after implementation of the DASH aligned congregate meals, compared to Baseline measurement (Month 0) before implementation of dietary or behavioral interventions
Secondary outcomes (6)
Sustainability of Change in Mean Systolic Blood Pressure at 3 months
Change in the mean of clients' systolic blood pressure measured at on-site assessments, reported in millimeters of Mercury (mm Hg)
Measured: Month 3 after implementation of DASH meals, compared to Baseline (Month 0), before implementation of any dietary or behavioral changes
Sustainability of Change in Mean Systolic Blood Pressure at 6 months
Change in the mean of clients' systolic blood pressure measured at on-site assessments, reported in millimeters of Mercury (mmHg)
Measured: Month 6 after full implementation of DASH meals, compared to Baseline (Month 0), before implementation of any dietary or behavioral changes
Enhanced self efficacy - self monitoring
Mean frequency of home blood pressure self-monitoring (number of measurements/week)
Measured: up to Month 1
Cognitive and behavioral change - change in medication adherence self-efficacy
Change in mean score on Medication Adherence Self-Efficacy Scale (MASES-R) - this survey/scale asks participants how confident they are they can adhere to prescribed medications in 15 different settings that challenge adherence; responses are captured on a 4 point scale from 1-not at all sure, 2-a little sure, 3-fairly sure, and 4-extremely sure. Higher scores are better.
Measured: 1 Month after full implementation of dietary changes, compared to Baseline measure
Client acceptance of meals
Mean Likert scale score (smiley card) score for DASH-aligned meals; Clients (participants) complete a meal evaluation card once a week, to reflect acceptance of recent menu offerings. The card asks, "Overall, How were the meals this week?" and asks the participant to rate the meals using a 5-point rating scale that ranges from unacceptable meals represented by a deeply frowning red face (1), through intermediates of a mildly frowning orange face (2), neutral expression yellow face (3), slightly smiling light green face (4), to a highly acceptable meal represented by a broadly smiling dark green face (5). Higher scores are better than lower values.
Measured: 1 month after full implementation of dietary changes, compared to Baseline before implementation of any dietary or behavioral changes
DASH-concordance of meals
This measure reflects to what degree the meals as served during the intervention, were DASH-aligned, according to the recommendations of the DASH eating adapted for the designed study menus. This concordance is expressed as the number of the 8 food group requirements satisfied (defined in the DASH eating plan and adapted for the study menus) by the meals as provided. The DASH eating plan identifies 8 groups: 1-Grains, 2-vegetables, 3-fruits, 4-fat-free/low fat milk and milk products, 5-lean meats, poultry and fish, 6-nuts, seeds and legumes, 7-fats and oils, 8-sweets and added sugar. The higher the score, the more DASH-concordant the meal. This outcome will report the mean daily meal DASH-concordance, e.g." 7.5 food group requirements satisfied." For components that allow for weekly requirements rather than daily requirements, (e.g. nuts/seeds) the score for the week (requirement satisfied - yes/no) will be applied to each day within that week.
Measured: During the first month of full implementation of dietary changes, compared to Baseline before implementation of any dietary or behavioral changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start27 Jun 2019
- Primary completion3 Mar 2020
- Study completion14 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an implementation study, testing whether provision of the evidence-based DASH diet for to community-living seniors as a portion of their daily intake, in the setting of congregate meals at senior centers, coupled with evidence-based home self-blood pressure monitoring, can lead to effective blood pressure lowering.
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- Carter Burden Network, Clinical Directors Network
- Responsible party
- Sponsor
- Investigators
- Rhonda G Kost, MD, Principal investigator, The Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993808
- Sponsor's protocol ID
- RKO-0990
- Status last verified
- Dec 2020
- First submitted
- 19 Jun 2019
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hashemi A, Vasquez K, Guishard D, Naji M, Ronning A, George-Alexander G, Vasquez D, Sylvester C, Pagano W, Khalida C, Coffran C, Ezeonu T, Fofana K, Bielopolski D, Vaughan R, Qureshi A, Tobin JN, Kost RG. Implementing DASH-aligned Congregate Meals and Self-Measured Blood Pressure in two senior centers: An open label study. Nutr Metab Cardiovasc Dis. 2022 Aug;32(8):1998-2009. doi: 10.1016/j.numecd.2022.05.018. Epub 2022 May 31.
PubMed 35752539
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cardiovascular Health Through Implementation of a Dietary Approaches to Stop Hypertension (DASH)-Diet-based Multi-component Intervention With Senior Services Programs
- ClinicalTrials.gov ID
- NCT03993808
- Acronym / sponsor ID
- RKO-0990
- Conditions
- Hypertension
- Keywords
- Nutrition, micro-nutrients, implementation, food insecurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- Carter Burden Network, Clinical Directors Network
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 21 Jun 2019 (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.
The Carter Burden Network (CBN) is an New York City senior services agency, providing vital meal programs for low-income, minority seniors, age 60 and over. In 2016, CBN formed a community-academic partnership with The Rockefeller University (RU) and Clinical Directors Network (CDN) to conduct a Healthy Aging pilot study and found that 84% of participants had high blood pressure, with up to 27% "uncontrolled" using age-adjusted criteria. High blood pressure is a modifiable risk for cardiovascular disease, and has been readily improved in controlled trials by replacement of a typical Western diet with the Dietary Approaches to Stop Hypertension (DASH) diet. The DASH diet has been proven to meaningfully reduce blood pressure in as little as 14 days. However, the DASH diet has not been tested in seniors, in the setting of senior centers. Many seniors attending CBN centers receive close to 40% of their daily nutrition through congregate meals served there. This study tests the effectiveness of implementing the DASH-diet through modification of congregate meals at CBN senior centers to align with DASH, while providing educational and behavioral support, including home self-monitoring of blood pressure, to improve self-efficacy related to blood pressure management. The primary outcome is the change in systolic blood pressure.
Detailed description
The Carter Burden Network (CBN) is an New York City senior services agency, providing vital meal programs for low-income, minority seniors, age 60 and over. Its four senior centers serve 300,000 meals annually through congregate breakfasts and lunches, and home-delivered meals. In 2016, CBN formed a community-academic partnership with The Rockefeller University (RU) and Clinical Directors Network (CDN) to conduct a Healthy Aging pilot study at two of its East Harlem sites, finding that 84% of participants had high blood pressure, with up to 27% "uncontrolled" by age-adjusted criteria. Hypertension continues to be a significant, modifiable, but poorly-controlled contributor to morbidity and mortality from cardiovascular disease (CVD), contributing to stroke, heart attack, renal failure, and cognitive decline, increasing healthcare costs and causing loss of function, independence, and quality of life. Replacement of a typical Western diet with the Dietary Approaches to Stop Hypertension (DASH) diet has been proven to reduce blood pressure in i hypertensive individuals, and individuals with normal blood pressure in as little as 14 days. However, approaches to effective implementation of the DASH diet are untested in community-living seniors.
To address the high cardiovascular risk of uncontrolled hypertension among seniors and introduce innovation into its nutritional program, CBN, RU and CDN designed this two year project to test a DASH-diet-based multi-component intervention to lower blood pressure in two of its senior centers, serving low-income and/or minority seniors. The intervention includes health education, participant input into menu design, redesign of current congregate meals menus to make them with DASH-aligned menus, and home-self monitoring of blood pressure with educational and social support. The primary outcome will be the change in mean systolic blood pressure, measured by health professionals one month after full DASH implementation, compared to baseline. Secondary outcomes include the change in the percentage of seniors with blood pressure in the range of "controlled" by Joint National Committee 8 (JNC-8) guidelines, and the change in blood pressure at three months and at six months.
To optimize acceptance of the changes to menu and recipes, clients will be engaged and provide feedback during the design, implementation and conduct phases of the study. Dietary changes will be planned to incorporate client preferences. Clients will provide feedback weekly on menu acceptability referencing a simple smiley face Likert scale. Educational programs will consist of a series of sessions covering nutritional education including recipes and cooking demonstrations, blood pressure information and training in home self-monitoring with a study-provided blue-tooth enabled Omron 10 device, and information to enhance medication adherence. Participants will have pulse, blood pressure, weight, and behavioral aspects of self-efficacy assessed at baseline, and at Months 1, 3, and 6 of after DASH implementation. Surveys to assess quality of life, food frequency (for compliance with DASH-aligned eating outside of congregate meals), menu satisfaction, medication adherence, and other risks relevant to blood pressure management will be assessed at the same Month 0,1,3,6 time points).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an implementation study, testing whether provision of the evidence-based DASH diet for to community-living seniors as a portion of their daily intake, in the setting of congregate meals at senior centers, coupled with evidence-based home self-blood pressure monitoring, can lead to effective blood pressure lowering.
| Arm | Type | Receives |
|---|---|---|
| Educational/behavioral support for hypertension self efficacy | Experimental | Behavioral: Revision of congregate meal menus and recipes to align with parameters of DASH eating plan, Behavioral: On-site blood pressure monitoring, Behavioral: Home self blood pressure monitoring, Behavioral: Medical adherence education, Behavioral: Nutrition EducationOn-site monitoring of pulse, blood pressure, weight, and surveys, at Months 0,1,3,6; Four educational sessions to address: 1) basics about blood pressure (BP); 2) training in home BP monitoring with personal Omron 10 device; 3) information about Dietary Intervention to lower Systemic Blood Pressure (DASH) eating plan, recipes and cooking demonstrations; 4) education about BP medication adherence. Interventions occur on the background of Carter Burden Network's implementation of a DASH-congruent menus for congregant meals for all seniors attending the sites, including those not enrolled in the protocol. |
Who may qualify
- Ages
- 60 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A client of the Carter Burden Leonard Covello Senior Center, or the 74th Street Luncheon Club, consuming one or more meals at the center, 4 or more days a week, for at least 3 months, by self report.
- Fluent in English or Spanish
- Currently planning to continue to receive meals at the CBN site (Leonard Covello or Luncheon Club) for the next 6 months
Key exclusion criteria (4 listed)
- A diagnosis of dementia, early dementia or other cognitive impairment reported by the study participant, the participant's caregiver, CBN staff, or the study team.
- Any condition, that in the opinion of the person obtaining consent, would interfere with the individual's ability to complete the assessments.
- Individuals who rely on a Legal Authorized Representative (LAR)
- Anticipated absence of more than a week, between enrollment and the 1 Month time point
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 |
|---|---|---|
| Revision of congregate meal menus and recipes to align with parameters of DASH eating planAlso: DASH dietOn a programmatic level, congregate meal menus and recipes have been adapted to align with DASH eating. The changes, which include the introduction of additional servings of fruits, vegetables, seeds, grains, replacement of simple or processed carbohydrates with healthier alternatives, introduction of more fish, reduction in added salt, and replacement of animal fats and butter with olive oil, will be phased-in in stages over 6 weeks, concurrent with the start up the study's educational programs addressing nutrition, BP, and medication adherence. The fully DASH-aligned menus will begin by week 7. The dietary intervention affects all seniors eating congregate meals at the center, not only those enrolled in this protocol to study the impact of DASH implementation. | Behavioural | Educational/behavioral support for hypertension self efficacy |
| On-site blood pressure monitoringAt baseline (Month 0), and at Months 1, 3, and 6 after the full implementation of the DASH aligned congregate meals, participants will have blood pressure measured by professionals, on-site at the senior center, following established standard procedures. They will receive verbal and written information about their blood pressure results, and encouragement to share the results with their providers. | Behavioural | Educational/behavioral support for hypertension self efficacy |
| Home self blood pressure monitoringAlso: self-measured blood pressure monitoring (SMBP)Provision of personal Omron 10 home blood pressure monitoring device, training in proper use, and schedule for home self monitoring of BP over the course of the study. | Behavioural | Educational/behavioral support for hypertension self efficacy |
| Medical adherence educationOne required educational session with the community pharmacist to learn about medication adherence strategies | Behavioural | Educational/behavioral support for hypertension self efficacy |
| Nutrition EducationOne required educational session to review the elements of the DASH eating plan, how to overcome barriers to healthy eating, recipes, cooking demonstrations and materials for household members. | Behavioural | Educational/behavioral support for hypertension self efficacy |
Primary outcome
Change in Systolic Blood Pressure
Time frame: One month after implementation of the DASH-aligned congregate meals, compared to Baseline measurement (Month 0) before implementation of dietary or behavioral interventions
Change in the mean of clients' systolic blood pressure measured at on-site assessments, reported in millimeters of Mercury (mm Hg).
Change in Proportion of individuals with Blood Pressure is in the "controlled" range
Time frame: One month after implementation of the DASH aligned congregate meals, compared to Baseline measurement (Month 0) before implementation of dietary or behavioral interventions
The proportion of individuals who blood pressure is within the range "controlled" according to 8th Joint National Committee (JNC-8) guidelines, which for individuals age >60 years, is systolic blood pressure <150 mm Hg, and diastolic blood pressure <90 mm Hg.
6 secondary outcomes
Sustainability of Change in Mean Systolic Blood Pressure at 3 months
Time frame: Month 3 after implementation of DASH meals, compared to Baseline (Month 0), before implementation of any dietary or behavioral changes
Sustainability of Change in Mean Systolic Blood Pressure at 6 months
Time frame: Month 6 after full implementation of DASH meals, compared to Baseline (Month 0), before implementation of any dietary or behavioral changes
Enhanced self efficacy - self monitoring
Time frame: up to Month 1
Cognitive and behavioral change - change in medication adherence self-efficacy
Time frame: 1 Month after full implementation of dietary changes, compared to Baseline measure
Client acceptance of meals
Time frame: 1 month after full implementation of dietary changes, compared to Baseline before implementation of any dietary or behavioral changes
DASH-concordance of meals
Time frame: During the first month of full implementation of dietary changes, compared to Baseline before implementation of any dietary or behavioral changes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Derived from this study: PubMed 35752539Hashemi A, Vasquez K, Guishard D, Naji M, Ronning A, George-Alexander G, Vasquez D, Sylvester C, Pagano W, Khalida C, Coffran C, Ezeonu T, Fofana K, Bielopolski D, Vaughan R, Qureshi A, Tobin JN, Kost RG. Implementing DASH-aligned Congregate Meals and Self-Measured Blood Pressure in two senior centers: An open label study. Nutr Metab Cardiovasc Dis. 2022 Aug;32(8):1998-2009. doi: 10.1016/j.numecd.2022.05.018. Epub 2022 May 31.
- 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.
Rhonda G Kost, MD principal investigator
The Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revision of congregate meal menus and recipes to align with parameters of DASH eating plan, On-site blood pressure monitoring and Home self blood pressure monitoring in people with Hypertension, run by Rockefeller University 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 9 Dec 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure (time frame: One month after implementation of the DASH-aligned congregate meals, compared to Baseline measurement (Month 0) before implementation of dietary or behavioral interventions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03993808, which also lists 1 linked publication.
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 9 Dec 2020; AzTrials last refreshed its copy on 28 Oct 2026.