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Nutritional Support
Medically Tailored Meals for Heart Failure
N/A
Recruiting
Led By Cheryl Anderson, PhD, MPH, MS
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Reported congestive heart failure (CHF) diagnosis
Be older than 18 years old
Must not have
Diagnosed with end-stage heart failure
Diagnosed with diabetes (type 1 or uncontrolled type 2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 4, 6, 8, and 12
Awards & highlights
No Placebo-Only Group
Summary
This trial will examine how giving specially prepared meals to people with heart disease for twelve weeks affects their diet quality. The main focus of the study is to see if the participants' diet improves by week
Who is the study for?
This trial is for individuals with heart disease, specifically those diagnosed with heart failure or congestive heart failure. The details of the inclusion and exclusion criteria are not provided, but typically participants would need to meet certain health conditions.
What is being tested?
The study is testing whether providing 14 or 15 medically tailored meals per week can improve the quality of diet in patients with heart failure over a period of twelve weeks, measured by the 'Healthy Eating Index'.
What are the potential side effects?
Since this trial involves medically tailored meals rather than medication, side effects may be minimal and related to dietary changes. However, specific side effects are not listed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with congestive heart failure.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with advanced heart failure.
Select...
I have been diagnosed with type 1 diabetes or my type 2 diabetes is not under control.
Select...
I am currently taking insulin or meglitinides for diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and weeks 4, 6, 8, and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and weeks 4, 6, 8, and 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in diet quality at Week 12, as determined by the Healthy Eating Index (HEI)
Secondary study objectives
Change in mean blood pressure
Change in reported access to healthy foods as assessed by the Food Consumption Score (FCS)
Change in reported food security as assessed by the Food Insecurity Experience Scale (FIES)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: 15 Medically Tailored Meals (MTM) + snacksExperimental Treatment1 Intervention
Participants will receive 15 medically tailored meals (MTM) per week, plus snacks, for 12 weeks.
Group II: 14 Medically Tailored Meals (MTM)Experimental Treatment1 Intervention
Participants will receive 14 medically tailored meals (MTM) per week for 12 weeks.
Find a Location
Who is running the clinical trial?
Stanford UniversityOTHER
2,474 Previous Clinical Trials
17,501,880 Total Patients Enrolled
20 Trials studying Heart Failure
56,368 Patients Enrolled for Heart Failure
University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,987 Total Patients Enrolled
16 Trials studying Heart Failure
56,519 Patients Enrolled for Heart Failure
Cheryl Anderson, PhD, MPH, MSPrincipal InvestigatorUC San Diego
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