(P22-052-23) Implementation and Effectiveness of the DASH Diet for Outpatient Heart Failure Management: Study Protocol and Challenges of a Pilot Pragmatic Clinical Trial

Objectives: The Dietary Approaches to Stop Hypertension (DASH) diet is efficacious for reducing blood pressure and cardiovascular disease risk. Emerging evidence suggests benefits of the DASH diet for heart failure (HF) management. However, effective pragmatic use of the DASH diet for HF patients has been limited. The purpose of this study is to evaluate the implementation and effectiveness of the DASH diet for outpatient HF management using behavioral, clinical, and laboratory correlative science approaches while optimizing patient recruitment, dietary education and treatment, and measurement methods.

Methods: This single-center prospective pilot pragmatic clinical trial uses a one-group pretest-posttest study design with a target n=25. Patients must have diagnosed heart failure, be aged ≥21 years, and be a patient in the participating university medical center heart failure clinic. Members of the research team are independently affiliated with a university and a university healthcare system. The intervention includes four outpatient medical nutrition therapy appointments with a registered dietitian providing nutrition education and counseling on the DASH diet. The primary outcome is blood pressure with secondary outcomes including diet adherence, quality of life, heart failure biomarkers, and plasma metabolites.

Results: Preliminary qualitative evaluation of patient recruitment and the study implementation process have identified challenges to study initiation and progress, including patient recruitment methods, insurance coverage, and integration of university researchers into the university healthcare setting. Maintaining a pragmatic study design instead of explanatory approaches has posed an additional challenge. Fidelity evaluations, patient participation incentives, and nutrition education materials were updated after patient recruitment initiation.

Conclusions: Though challenges remain, protocol revisions have improved study progress. Patient recruitment, intervention implementation, and data collection are ongoing. Results from this pilot study will inform a larger randomized controlled trial to personalize precision nutrition care in cardiovascular healthcare.

Funding Sources: American College of Cardiology Foundation; USDA Agricultural Experiment Station