Food is Medicine for Patients with Heart Failure

Last updated: November 27, 2024
Sponsor: University of California, San Diego
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Congestive Heart Failure

Heart Failure

Treatment

14 Medically Tailored Meals (MTM) per week

15 Medically Tailored Meals (MTM) per week

Clinical Study ID

NCT06540118
24RPGFIM1198191
  • Ages > 18
  • All Genders

Study 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."

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Willingness to comply with all study procedures and availability for the duration ofthe 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

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 withthe ability to eat study-provided meals, including foods that are prepared in afacility 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 inEnglish

  • Those who, in the opinion of the investigators, cannot reliably complete the studyprotocol

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: 14 Medically Tailored Meals (MTM) per week
Phase:
Study Start date:
October 17, 2024
Estimated Completion Date:
June 30, 2025

Study 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).

Connect with a study center

  • University of California San Diego

    La Jolla, California 92093
    United States

    Site Not Available

  • Stanford University

    Stanford, California 94305
    United States

    Active - Recruiting

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