Food Is Medicine for Patients With Heart Failure

University of California San Diego

Status: Completed

Conditions: Heart Failure; Heart Diseases; Heart Failure，Congestive

Treatments: Other: 15 Medically Tailored Meals (MTM) per week; Other: 14 Medically Tailored Meals (MTM) per week

Study type: Interventional

Funder types: Other

Identifiers

NCT06540118

24RPGFIM1198191

Details and patient eligibility

About

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."

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

15 Medically Tailored Meals (MTM) + snacks

Experimental group

Description:

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

Treatment:

Other: 15 Medically Tailored Meals (MTM) per week

14 Medically Tailored Meals (MTM)

Experimental group

Description:

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

Treatment:

Other: 14 Medically Tailored Meals (MTM) per week