Food Is Medicine for Patients With Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-17

Study Completion Date

2025-07-28

Brief Summary

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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."

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Detailed Description

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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).

Conditions

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Heart Failure Heart Failure，Congestive Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

By the nature of the dietary intervention, it is impossible to blind participants to study arm assignment. However, research staff collecting outcome data, apart from dietary adherence data, will remain blinded to participants' assigned study arm throughout data collection. Additionally, the statistician(s) analyzing data for efficacy of the intervention will use a dataset with study arm masked in order to remain blinded to the assigned intervention for the final analysis.

Study Groups

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15 Medically Tailored Meals (MTM) + snacks

Participants will receive 15 medically tailored meals (MTM) per week, plus snacks, for 12 weeks.

Group Type EXPERIMENTAL

15 Medically Tailored Meals (MTM) per week

Intervention Type OTHER

15 heart-healthy medically tailored meals delivered to participants each week. Meals include breakfast, lunch, dinner, and snack to consume Monday-Friday.

14 Medically Tailored Meals (MTM)

Participants will receive 14 medically tailored meals (MTM) per week for 12 weeks.

Group Type EXPERIMENTAL

14 Medically Tailored Meals (MTM) per week

Intervention Type OTHER

14 heart-healthy medically tailored meals delivered to participants each week. Meals include lunch and dinner to consume Monday-Sunday.

Interventions

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15 Medically Tailored Meals (MTM) per week

15 heart-healthy medically tailored meals delivered to participants each week. Meals include breakfast, lunch, dinner, and snack to consume Monday-Friday.

Intervention Type OTHER

14 Medically Tailored Meals (MTM) per week

14 heart-healthy medically tailored meals delivered to participants each week. Meals include lunch and dinner to consume Monday-Sunday.

Intervention Type OTHER

Eligibility Criteria

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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
* Currently taking Glucagon-Like Peptide-1 (GLP-1) Agonists medications and not stable on a maximum maintenance dose for a minimum of 1 month
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No