DASH Diet Intervention at Senior Centers

NCT03993808 | Completed

• 1 other identifier: RKO-0990
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Nutrition, micro-nutrients, implementation, food insecurity

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  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

  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

  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

  up to Month 1

• Cognitive and behavioral change - change in medication adherence self-efficacy

  1 Month after full implementation of dietary changes, compared to Baseline measure

• Client acceptance of meals

  1 month after full implementation of dietary changes, compared to Baseline before implementation of any dietary or behavioral changes

Study Arms (1)

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.

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

Interventions

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

Also known as: DASH diet

Educational/behavioral support for hypertension self efficacy

On-site blood pressure monitoring 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.

Educational/behavioral support for hypertension self efficacy

Home self blood pressure monitoring 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.

Also known as: self-measured blood pressure monitoring (SMBP)

Educational/behavioral support for hypertension self efficacy

Medical adherence education BEHAVIORAL

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

Educational/behavioral support for hypertension self efficacy

Nutrition Education 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.

Educational/behavioral support for hypertension self efficacy

Eligibility Criteria

• Age: 60 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rockefeller University: lead
• Carter Burden Network: collaborator
• Clinical Directors Network: collaborator

Study Sites (1)

Carter Burden Network Leonard Covello Center

New York, New York, 10029, United States

Location

Related Publications (1)

• 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.

  PMID: 35752539 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Dietary Approaches To Stop Hypertension; Nutrition Assessment

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Rhonda G Kost, MD

  The Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 21, 2019
• Study Start: June 27, 2019
• Primary Completion: March 3, 2020
• Study Completion: October 14, 2020
• Last Updated: December 9, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)