Food is Medicine for Patients with Heart Failure
Purpose
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."
Conditions
- Heart Failure
- Heart Failure，Congestive
- Heart Diseases
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
- Masking Description
- By the nature of the dietary intervention, it is impossible to blind participants to study arm assignment. However, research staff collecting outcome data, apart from dietary adherence data, will remain blinded to participants' assigned study arm throughout data collection. Additionally, the statistician(s) analyzing data for efficacy of the intervention will use a dataset with study arm masked in order to remain blinded to the assigned intervention for the final analysis.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 15 Medically Tailored Meals (MTM) + snacks |
Participants will receive 15 medically tailored meals (MTM) per week, plus snacks, for 12 weeks. |
|
|
Experimental 14 Medically Tailored Meals (MTM) |
Participants will receive 14 medically tailored meals (MTM) per week for 12 weeks. |
|
Recruiting Locations
Stanford, California 94305
More Details
- NCT ID
- NCT06540118
- Status
- Recruiting
- Sponsor
- University of California, San Diego
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).