Food Is Medicine for Patients With Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- 14 Medically Tailored Meals (MTM) per week
- Conditions
- Heart Failure
- Sponsor
- University of California, San Diego
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change in diet quality at Week 12, as determined by the Healthy Eating Index (HEI)
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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).
Investigators
Cheryl A. Anderson, MPH, PhD
Professor and Dean
University of California, San Diego
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
- •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
Arms & Interventions
14 Medically Tailored Meals (MTM)
Participants will receive 14 medically tailored meals (MTM) per week for 12 weeks.
Intervention: 14 Medically Tailored Meals (MTM) per week
15 Medically Tailored Meals (MTM) + snacks
Participants will receive 15 medically tailored meals (MTM) per week, plus snacks, for 12 weeks.
Intervention: 15 Medically Tailored Meals (MTM) per week
Outcomes
Primary Outcomes
Change in diet quality at Week 12, as determined by the Healthy Eating Index (HEI)
Time Frame: 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 Outcomes
- Participant satisfaction with delivery of medically tailored meals for individuals with heart failure(Week 4 and Week 12)
- Change in reported access to healthy foods as assessed by the Food Consumption Score (FCS)(Baseline, Week 12, and Week 24)
- Dietary adherence to meal assignment using daily food diaries and 24-hour dietary recalls(Baseline and Weeks 4, 6, 8, and 12)
- Change in reported food security as assessed by the Food Insecurity Experience Scale (FIES)(Baseline, Week 12, Week 24)
- Change in Hemoglobin A1C (HbA1C) levels(Baseline and Week 12)
- Change in weight(Baseline and Week 12)
- 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)
- Change in mean blood pressure(Baseline and Week 12)
- Change in blood lipid levels(Baseline and Week 12)