Clinical trial NCT03993808: DASH Diet Intervention at Senior Centers
Official title: Improving Cardiovascular Health Through Implementation of a Dietary Approaches to Stop Hypertension (DASH)-Diet-based Multi-component Intervention With Senior Services Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Nutrition, micro-nutrients, implementation, food insecurity
Lead sponsor: Rockefeller University
Sponsor class: OTHER
Collaborators: name: Carter Burden Network
name: Clinical Directors Network
First posted: 2019-06-21
Enrollment: 94
Sex: ALL
Minimum age (years): 60
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Systolic Blood Pressure
timeFrame: One month after implementation of the DASH-aligned congregate meals, compared to Baseline measurement (Month 0) before implementation of dietary or behavioral interventions
measure: Change in Proportion of individuals with Blood Pressure is in the "controlled" range
timeFrame: 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:
measure: Sustainability of Change in Mean Systolic Blood Pressure at 3 months
timeFrame: Month 3 after implementation of DASH meals, compared to Baseline (Month 0), before implementation of any dietary or behavioral changes
measure: Sustainability of Change in Mean Systolic Blood Pressure at 6 months
timeFrame: Month 6 after full implementation of DASH meals, compared to Baseline (Month 0), before implementation of any dietary or behavioral changes
measure: Enhanced self efficacy - self monitoring
timeFrame: up to Month 1
measure: Cognitive and behavioral change - change in medication adherence self-efficacy
timeFrame: 1 Month after full implementation of dietary changes, compared to Baseline measure
measure: Client acceptance of meals
timeFrame: 1 month after full implementation of dietary changes, compared to Baseline before implementation of any dietary or behavioral changes
measure: DASH-concordance of meals
timeFrame: During the first month of full implementation of dietary changes, compared to Baseline before implementation of any dietary or behavioral changes
Other outcomes:
Locations:
city: New York
country: United States
facility: Carter Burden Network Leonard Covello Center
state: New York
Study officials:
affiliation: The Rockefeller University
name: Rhonda G Kost, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.