Clinical trial NCT06540118: Food Is Medicine for Patients With Heart Failure
Official title: Food Is Medicine for Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Heart Failure，Congestive
Heart Diseases
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2024-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in diet quality at Week 12, as determined by the Healthy Eating Index (HEI)
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Participant satisfaction with delivery of medically tailored meals for individuals with heart failure
timeFrame: Week 4 and Week 12
measure: Dietary adherence to meal assignment using daily food diaries and 24-hour dietary recalls
timeFrame: Baseline and Weeks 4, 6, 8, and 12
measure: Change in reported access to healthy foods as assessed by the Food Consumption Score (FCS)
timeFrame: Baseline, Week 12, and Week 24
measure: Change in reported food security as assessed by the Food Insecurity Experience Scale (FIES)
timeFrame: Baseline, Week 12, Week 24
measure: Change in reported food security as assessed by the Short Form of the U.S. Adult Food Security Survey Module
timeFrame: Baseline, Week 12, Week 24
measure: Change in mean blood pressure
timeFrame: Baseline and Week 12
measure: Change in blood lipid levels
timeFrame: Baseline and Week 12
measure: Change in Hemoglobin A1C (HbA1C) levels
timeFrame: Baseline and Week 12
measure: Change in weight
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: UC San Diego
name: Cheryl Anderson, PhD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Christopher Gardner, PhD
role: PRINCIPAL_INVESTIGATOR
References: