Food Is Medicine for Patients With Heart Failure
NCT Number: NCT06540118
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure|Heart Failure，Congestive|Heart Diseases
Interventions: OTHER: 15 Medically Tailored Meals (MTM) per week|OTHER: 14 Medically Tailored Meals (MTM) per week
Sponsor: University of California, San Diego
Collaborators: Stanford University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-30
Completion Date: 2025-06-30
Locations: University of California San Diego, La Jolla, California, 92093, United States|Stanford University, Stanford, California, 94305, United States

Summary:
This study will look at the effects of providing medically tailored meals (MTMs) to people with heart disease for twelve weeks. The primary outcome of the study is the quality of the diet being consumed in week 12 of the study, as determined by the "Healthy Eating Index."

Primary Outcome Measures: Change in diet quality at Week 12, as determined by the Healthy Eating Index (HEI), HEI will be used to determine diet quality based on dietary recall data collected via NDSR, Baseline and Week 12
Secondary Outcome Measures: Participant satisfaction with delivery of medically tailored meals for individuals with heart failure, Participant satisfaction will be assessed using a study-specific self-administered questionnaire that uses a 5-point Likert scale. Participants will be asked to rate their experiences with multiple aspects of the provided study meals (including taste, variety, quality, cultural appropriateness, amount of food, visual appeal, and delivery) from "poor" to "excellent"., Week 4 and Week 12|Dietary adherence to meal assignment using daily food diaries and 24-hour dietary recalls, Participants' qualitative daily food diaries and quantitative dietary analyses based on interviewer-assisted dietary recalls using Nutrition Data System for Research (NDSR) software will be combined to determine the proportion of provided meals that participants consumed., Baseline and Weeks 4, 6, 8, and 12|Change in reported access to healthy foods as assessed by the Food Consumption Score (FCS), The Food Consumption Score aggregates household-level data on the diversity and frequency of food groups consumed over the previous seven days, which is then weighted according to the relative nutritional value of the consumed food groups. The Food Consumption Score scale ranges from 0-112, with higher scores indicating better food consumption status., Baseline, Week 12, and Week 24|Change in reported food security as assessed by the Food Insecurity Experience Scale (FIES), The Food Insecurity Experience Scale (FIES) consists of eight questions regarding people's access to adequate food during the last 30 days. The raw score scale ranges from 0-8, with a higher score indicating more food insecurity experiences. Scale items are analyzed together as a scale, not be reported in terms of percent of positive responses to individual questions. The classifications of food insecurity severity based on responses may be described as mild, moderate, and severe food insecurity., Baseline, Week 12, Week 24|Change in reported food security as assessed by the Short Form of the U.S. Adult Food Security Survey Module, The 6-item survey collects information about whether participants had access to and were able to afford enough food in the last 30 days. The survey allows for stratification of participants into one of four food security categories based on their responses - high food security, marginal food security, low food security, and very low food security. The raw score scale ranges from 0 - 6, with a higher score indicating lower food security., Baseline, Week 12, Week 24|Change in mean blood pressure, Mean blood pressure will be calculated based on 3 consecutive readings in the research clinic during each in-person study visit., Baseline and Week 12|Change in blood lipid levels, Baseline and Week 12|Change in Hemoglobin A1C (HbA1C) levels, Baseline and Week 12|Change in weight, Weight will be measured by study personnel at each in-person study visit., Baseline and Week 12