Condition or disease | Intervention/treatment | Phase |
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Hypertension | 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 | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 94 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention 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) |
Primary Purpose: | Other |
Official Title: | Improving Cardiovascular Health Through Implementation of a Dietary Approaches to Stop Hypertension (DASH)-Diet-based Multi-component Intervention With Senior Services Programs |
Actual Study Start Date : | June 27, 2019 |
Actual Primary Completion Date : | March 3, 2020 |
Actual Study Completion Date : | October 14, 2020 |
Arm | Intervention/treatment |
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Experimental: Educational/behavioral support for hypertension self efficacy
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.
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Behavioral: Revision of congregate meal menus and recipes to align with parameters of DASH eating plan
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.
Other Name: DASH diet
Behavioral: On-site blood pressure monitoring 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.
Behavioral: Home self blood pressure monitoring 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.
Other Name: self-measured blood pressure monitoring (SMBP)
Behavioral: Medical adherence education One required educational session with the community pharmacist to learn about medication adherence strategies
Behavioral: Nutrition Education 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.
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Ages Eligible for Study: | 60 Years to 105 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Carter Burden Network Leonard Covello Center | |
New York, New York, United States, 10029 |
Principal Investigator: | Rhonda G Kost, MD | The Rockefeller University |
Tracking Information | |||||
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First Submitted Date ICMJE | June 19, 2019 | ||||
First Posted Date ICMJE | June 21, 2019 | ||||
Last Update Posted Date | December 9, 2020 | ||||
Actual Study Start Date ICMJE | June 27, 2019 | ||||
Actual Primary Completion Date | March 3, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | DASH Diet Intervention at Senior Centers | ||||
Official Title ICMJE | Improving Cardiovascular Health Through Implementation of a Dietary Approaches to Stop Hypertension (DASH)-Diet-based Multi-component Intervention With Senior Services Programs | ||||
Brief 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 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). |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention 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)Primary Purpose: Other |
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Condition ICMJE | Hypertension | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Educational/behavioral support for hypertension self efficacy
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.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
94 | ||||
Original Estimated Enrollment ICMJE |
200 | ||||
Actual Study Completion Date ICMJE | October 14, 2020 | ||||
Actual Primary Completion Date | March 3, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 60 Years to 105 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03993808 | ||||
Other Study ID Numbers ICMJE | RKO-0990 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Rockefeller University | ||||
Study Sponsor ICMJE | Rockefeller University | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Rockefeller University | ||||
Verification Date | December 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |