Providing tailored meals to heart failure patients
Food is Medicine for Patients with Heart Failure
This study is testing if providing personalized meals can help adults with heart failure eat better and improve their health over twelve weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 2 sites (La Jolla, California and 1 other locations) |
| Trial ID | NCT06540118 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of medically tailored meals (MTMs) on adults with heart failure over a twelve-week period. Participants will be randomly assigned to receive either 15 or 14 MTMs each week, with the primary outcome being the quality of their diet assessed by the Healthy Eating Index at the end of the study. Secondary outcomes will include patient satisfaction, adherence to the meal plan, and various clinical measures such as blood cholesterol and blood pressure. The study aims to determine if tailored nutrition can improve dietary quality and health outcomes in this population.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with congestive heart failure who live in the San Diego or Bay Area and are willing to improve their diet.
Not a fit: Patients with end-stage heart failure, diabetes, or severe food allergies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance dietary quality and overall health for patients with heart failure.
How similar studies have performed: Other studies have shown promising results with tailored nutritional interventions for chronic conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
La Jolla, California and 1 other locations
- University of California San Diego — La Jolla, California, United States (Not_yet_recruiting)
- Stanford University — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Cheryl Anderson, PhD, MPH, MS — UC San Diego
- Study coordinator: Valerie Mercer, MPH, MA
- Email: vjmercer@ucsd.edu
- Phone: 858-246-5560
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.