Food is Medicine for Patients with Heart Failure

Not Applicable

Recruiting

• Conditions: Heart Failure; Heart Failure，Congestive; Heart Diseases
• Interventions: Other: 14 Medically Tailored Meals (MTM) per week; Other: 15 Medically Tailored Meals (MTM) per week

• Registration Number: NCT06540118
• Lead Sponsor: University of California, San Diego

Brief 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."

Detailed Description

This study will look at the effects of providing medically tailored meals (MTMs) to people with heart disease for twelve weeks. Sixty adults with heart failure will be recruited from the San Diego and San Francisco Bay Area of California. They will be randomly assigned to two groups: 1) a group that receives 15 "medically tailored meals" plus snacks each week for 12 weeks, 2) a group that receives 14 "medically tailored meals" each week for 12 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". Many other secondary outcomes will be assessed including both qualitative factors (e.g., satisfaction, preferences, adherence) and quantitative clinically measures (e.g., blood cholesterol, blood pressure, weight).

Study Timeline

• Study First Submitted: 2024-07-24
• Study First Submitted QC: 2024-08-01
• Study First Posted: 2024-08-06
• Study Start: 2024-10-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Willingness to comply with all study procedures and availability for the duration of the study
• Living in San Diego or the Bay Area of California
• Reported congestive heart failure (CHF) diagnosis
• Current diet can be improved
• Willing to eat all meals provided by the study

Exclusion Criteria

• Diagnosed with end-stage heart failure
• Diagnosed with diabetes (type 1 or uncontrolled type 2)
• Currently taking insulin and/or meglitinides medications
• Hemoglobin A1c (HbA1c) results >8 %
• Life expectancy of <1 year
• Pregnancy or lactation
• Known severe allergic reactions and/or food intolerances that would interfere with the ability to eat study-provided meals, including foods that are prepared in a facility that works with the allergen
• Current smoker or tobacco use within the past year
• Planning to leave San Diego or the Bay Area during the course of the study
• Unable to communicate reasonably well either orally or through written material in English
• Those who, in the opinion of the investigators, cannot reliably complete the study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
14 Medically Tailored Meals (MTM)	14 Medically Tailored Meals (MTM) per week	Participants will receive 14 medically tailored meals (MTM) per week for 12 weeks.
15 Medically Tailored Meals (MTM) + snacks	15 Medically Tailored Meals (MTM) per week	Participants will receive 15 medically tailored meals (MTM) per week, plus snacks, for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in diet quality at Week 12, as determined by the Healthy Eating Index (HEI)	Baseline and Week 12	HEI will be used to determine diet quality based on dietary recall data collected via Nutrition Data System for Research (NDSR) software. HEI scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations and dietary patterns published in the Dietary Guidelines for Americans.

Secondary Outcome Measures

Name	Time	Method
Participant satisfaction with delivery of medically tailored meals for individuals with heart failure	Week 4 and Week 12	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".
Change in reported access to healthy foods as assessed by the Food Consumption Score (FCS)	Baseline, Week 12, and Week 24	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.
Dietary adherence to meal assignment using daily food diaries and 24-hour dietary recalls	Baseline and Weeks 4, 6, 8, and 12	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.
Change in reported food security as assessed by the Food Insecurity Experience Scale (FIES)	Baseline, Week 12, Week 24	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.
Change in Hemoglobin A1C (HbA1C) levels	Baseline and Week 12
Change in weight	Baseline and Week 12	Weight will be measured by study personnel at each in-person study visit.
Change in reported food security as assessed by the Short Form of the U.S. Adult Food Security Survey Module	Baseline, Week 12, Week 24	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.
Change in mean blood pressure	Baseline and Week 12	Mean blood pressure will be calculated based on 3 consecutive readings in the research clinic during each in-person study visit.
Change in blood lipid levels	Baseline and Week 12

Trial Locations

Locations (2)

University of California San Diego; 🇺🇸 La Jolla, California, United States

Stanford University; 🇺🇸 Stanford, California, United States