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Medically-Tailored Meals + Protein Shakes for Heart Failure (FAM-HF Trial)
N/A
Waitlist Available
Led By Amanda Vest, MBBS MPH
Research Sponsored by Tufts Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from start to end of 12-week mtm period
Awards & highlights
FAM-HF Trial Summary
This trial will study whether providing medically-tailored meals or protein supplementation shakes to patients with heart failure and malnutrition improves their outcomes.
Who is the study for?
This trial is for adults with heart failure and malnutrition in the Boston area who've been hospitalized before. They must have a specific type of heart failure (HFrEF) with certain symptoms, not be pregnant or planning pregnancy, and able to store meals at home.Check my eligibility
What is being tested?
The study tests if medically-tailored meals or daily protein shakes can improve health in heart failure patients with poor nutrition. It's a pilot trial where everyone gets the food interventions one after another, not at random.See study design
What are the potential side effects?
Since this trial involves food-based interventions like special meals and protein shakes, side effects might include digestive discomfort or allergic reactions if participants have unknown food sensitivities.
FAM-HF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from start to end of 12-week mtm period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from start to end of 12-week mtm period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6 minute walk test
Diet Satisfaction scale (DSat-28)
Handgrip strength measurement in kg
+2 moreSecondary outcome measures
Facilitated food recall
Short Nutritional Assessment Questionnaire (SNAQ)
Weight
FAM-HF Trial Design
2Treatment groups
Experimental Treatment
Group I: 12 weeks of protein supplementation shakesExperimental Treatment1 Intervention
Participants will receive 1 bottle of Ensure Max Protein shake every day (any flavor option without caffeine, daily for 12 weeks) to take in addition to their standard diet, without MTM delivery.
Group II: 12 weeks of medically-tailored meals (MTMs)Experimental Treatment1 Intervention
12 weeks of home-delivered medically-tailored meals (MTMs), prepared and delivered by the non-profit Community Servings. The MTM has be developed specifically for patients with heart failure, with an approximate protein intake range of 1.1-1.5 g/kg body weight/day and a maximum of 2000 mg sodium/day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Protein supplementation shakes
2021
N/A
~10
Find a Location
Who is running the clinical trial?
Community ServingsUNKNOWN
3 Previous Clinical Trials
500 Total Patients Enrolled
Tufts Medical CenterLead Sponsor
252 Previous Clinical Trials
252,992 Total Patients Enrolled
10 Trials studying Heart Failure
2,730 Patients Enrolled for Heart Failure
Amanda Vest, MBBS MPHPrincipal InvestigatorTufts Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood pressure is too low or your heart rate is too high.You have galactosemia.You have had a heart transplant or a left ventricular assist device implanted in the past.You have a muscle disorder that is not related to your heart, such as muscular dystrophy or cancer.You have a specific type of heart condition with certain symptoms and reduced heart function.You have been in the hospital at least once in the past year.You have signs of malnutrition on a screening test for malnutrition.
Research Study Groups:
This trial has the following groups:- Group 1: 12 weeks of medically-tailored meals (MTMs)
- Group 2: 12 weeks of protein supplementation shakes
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies available in this clinical experiment?
"Clinicaltrials.gov reveals that recruitment for this trial is ongoing, having been posted on April 16th 2021 and recently updated on August 5th 2022."
Answered by AI
How many participants are joining this medical experiment?
"Correct. Per the data hosted on clinicaltrials.gov, this medical research was posted on April 16th 2021 and is actively seeking participants. This project requires a total of 16 patients to be recruited from one site."
Answered by AI
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