DASH Diet Intervention at Senior Centers

NCT ID: NCT03993808

Last Updated: 2020-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-27
• Study Completion Date: 2020-10-14

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).

Conditions

Hypertension

Keywords

Nutrition, micro-nutrients, implementation, food insecurity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Revision of congregate meal menus and recipes to align with parameters of DASH eating plan

Intervention Type: BEHAVIORAL

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 monitoring

Intervention Type: BEHAVIORAL

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 monitoring

Intervention Type: BEHAVIORAL

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 education

Intervention Type: BEHAVIORAL

One required educational session with the community pharmacist to learn about medication adherence strategies

Nutrition Education

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Medical adherence education

One required educational session with the community pharmacist to learn about medication adherence strategies

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

DASH diet; self-measured blood pressure monitoring (SMBP)

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Carter Burden Network

UNKNOWN

Sponsor Role: collaborator

Clinical Directors Network

NETWORK

Sponsor Role: collaborator

Rockefeller University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rhonda G Kost, MD

Role: PRINCIPAL_INVESTIGATOR

The Rockefeller University

Locations

Carter Burden Network Leonard Covello Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35752539 (View on PubMed)

Other Identifiers

RKO-0990

Identifier Type: -

Identifier Source: org_study_id