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Food As Medicine for Heart Failure (FAM-HF)

Primary Purpose

Heart Failure, Malnutrition

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medically-Tailored Meals (MTMs)
Protein supplementation shakes
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, malnutrition, weight loss, cachexia, nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Systolic heart failure (left ventricular ejection fraction </=40%), with New York Heart Association (NYHA) class II-III symptoms
  2. At least one prior hospitalization in the preceding 12 months
  3. Evidence of malnutrition on the Short Nutritional Assessment Questionnaire (SNAQ) screening tool for malnutrition (score of 2 or more)
  4. Have a fixed address within the Metro Boston region and availability of home refrigeration to accommodate the MTM deliveries
  5. Able and willing to sign study consent
  6. 18 years or above
  7. Not currently pregnant and not imminently planning a pregnancy

Exclusion Criteria:

  1. Prior heart transplantation or implantation of a left ventricular assist device
  2. Patients with a non-cardiac etiology for a skeletal muscle disorder e.g. muscular dystrophy, cancer
  3. Currently pregnant or planning to become pregnant
  4. Food allergy, aversion, or dietary preference that cannot be accommodated by Community Servings
  5. Systolic blood pressure at screening <90 mmHg, or heart rate >110 bpm
  6. Galactosemia

Sites / Locations

  • Tufts Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

12 weeks of medically-tailored meals (MTMs)

12 weeks of protein supplementation shakes

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Kansas City Cardiomyopathy Questionnaire (KCCQ)
Patient reported health measure (scale 0 to 100, higher indicates better health status)
Handgrip strength measurement in kg
Upper extremity strength measured by dynamometer (higher kg achieved indicates greater strength)
Sit-to-stand test
Lower extremity strength measure (lower time indicates greater strength)
6 minute walk test
Strength and endurance measure
Diet Satisfaction scale (DSat-28)
Dietary satisfaction measure

Secondary Outcome Measures

Short Nutritional Assessment Questionnaire (SNAQ)
Appetite questionnaire (score ranges 0 to 7, >/=3 indicating a severe malnutrition risk)
Facilitated food recall
3-day 24-hour facilitated food recall
Weight
Subject's body weight, measured on standing scale

Full Information

First Posted
April 7, 2021
Last Updated
August 24, 2023
Sponsor
Tufts Medical Center
Collaborators
Community Servings
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1. Study Identification

Unique Protocol Identification Number
NCT04847973
Brief Title
Food As Medicine for Heart Failure
Acronym
FAM-HF
Official Title
Food As Medicine for Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
Community Servings

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Malnutrition and unintentional weight loss are highly prevalent among patients with heart failure (HF), with approximately 50% of patients with heart failure meeting malnutrition criteria. Poor dietary quality and micronutrient deficiencies are associated with higher rates of HF hospitalization and mortality. Therefore nutritional interventions to improve dietary quality and prevent malnutrition development may represent an effective strategy to improve HF-related health status and survival outcomes. To date, there are no large clinical trials investigating the efficacy of 'food as medicine' to improve morbidity and mortality for patients with heart failure with reduced ejection fraction (HFrEF). The investigators plan to conduct a single-center, randomized pilot trial to assess the tolerability, feasibility, and efficacy of providing medically-tailored meals (MTMs) or protein supplementation shakes to patients with HFrEF and malnutrition. The investigators hypothesize that home delivery of MTMs or protein supplementation shakes will be feasible, well-tolerated and achieve a high degree of satisfaction for patients with HFrEF. The current pilot phase is a single arm non-randomized study. An initial phase has delivered a 12-week MTM dietary intervention. The MTMs are designed, prepared and delivered by our community based organized partner, Community Servings. A second phase will deliver a 12-week protein supplementation shake intervention, with 1 bottle to be consumed daily in addition to the participants' standard home diet. The investigators will measure HF-related health status, functional capacity, and biomarkers of heart failure and nutritional status before and after each study phase. The proposed study will facilitate a larger future randomized trial of nutritional intervention for patients with HFrEF and malnutrition, powered to examine the impact on HF hospitalizations and mortality.
Detailed Description
We plan to conduct a single-center pilot trial to assess the tolerability, feasibility, and efficacy of providing medically-tailored meals to patients with heart failure with reduced ejection fraction and malnutrition. We hypothesize that a nutritionally complete meal plan, targeting 1.1-1.5 g/kg/day protein intake, will improve symptomatology, functional capacity, and serum biomarkers of heart failure in this patient population. We have two primary objectives for this pilot study: 1) confirm tolerability, feasibility, and efficacy of prescribing MTMs or oral protein supplementation and 2) measure changes in functional capacity, patient-reported health status, and biomarkers of nutritional status and heart failure over the course of the study period. For this proposed study, we will test the following elements of this central hypothesis with 2 aims: Aim 1 Tolerability, feasibility, and efficacy of prescribing medically-tailored meals or protein supplementation: Tolerability will be assessed with the validated 28-item dietary satisfaction score (DSat-28). Efficacy will be assessed by improvement in patient-reported health status questionnaires and feasibility will be assessed by the macronutrient intakes achieved on facilitated food recalls. Aim 2 Functional capacity and serum biomarkers of nutrition/heart failure: Determine whether medically tailored meals improve symptomatology, functional capacity, and serum biomarkers of nutrition and heart failure in patients with advanced heart failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Malnutrition
Keywords
heart failure, malnutrition, weight loss, cachexia, nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
12 weeks of medically-tailored meals (MTMs)
Arm Type
Experimental
Arm Description
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.
Arm Title
12 weeks of protein supplementation shakes
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Medically-Tailored Meals (MTMs)
Intervention Description
12 weeks of home-delivered MTMs, delivered weekly, containing food for 3 meals per day on 5 days of the week
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein supplementation shakes
Intervention Description
12 weeks of 1 bottle of Ensure Max Protein shake every day, in addition to partcipants' standard diet
Primary Outcome Measure Information:
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
Patient reported health measure (scale 0 to 100, higher indicates better health status)
Time Frame
Change from start to end of 12-week MTM period
Title
Handgrip strength measurement in kg
Description
Upper extremity strength measured by dynamometer (higher kg achieved indicates greater strength)
Time Frame
Change from start to end of 12-week MTM period
Title
Sit-to-stand test
Description
Lower extremity strength measure (lower time indicates greater strength)
Time Frame
Change from start to end of 12-week MTM period
Title
6 minute walk test
Description
Strength and endurance measure
Time Frame
Change from start to end of 12-week MTM period
Title
Diet Satisfaction scale (DSat-28)
Description
Dietary satisfaction measure
Time Frame
Change from start to end of 12-week MTM period
Secondary Outcome Measure Information:
Title
Short Nutritional Assessment Questionnaire (SNAQ)
Description
Appetite questionnaire (score ranges 0 to 7, >/=3 indicating a severe malnutrition risk)
Time Frame
Change from start to end of 12-week MTM period
Title
Facilitated food recall
Description
3-day 24-hour facilitated food recall
Time Frame
Change from start to end of 12-week MTM period
Title
Weight
Description
Subject's body weight, measured on standing scale
Time Frame
Change from start to end of 12-week MTM period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Systolic heart failure (left ventricular ejection fraction </=40%), with New York Heart Association (NYHA) class II-III symptoms At least one prior hospitalization in the preceding 12 months Evidence of malnutrition on the Short Nutritional Assessment Questionnaire (SNAQ) screening tool for malnutrition (score of 2 or more) Have a fixed address within the Metro Boston region and availability of home refrigeration to accommodate the MTM deliveries Able and willing to sign study consent 18 years or above Not currently pregnant and not imminently planning a pregnancy Exclusion Criteria: Prior heart transplantation or implantation of a left ventricular assist device Patients with a non-cardiac etiology for a skeletal muscle disorder e.g. muscular dystrophy, cancer Currently pregnant or planning to become pregnant Food allergy, aversion, or dietary preference that cannot be accommodated by Community Servings Systolic blood pressure at screening <90 mmHg, or heart rate >110 bpm Galactosemia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Vest, MBBS MPH
Phone
617-636-8068
Ext
3
Email
avest@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Esposito, MD
Email
mesposito@tuftsmedicalcenter.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Vest, MBBS MPH
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Vest, MBBS MPH
First Name & Middle Initial & Last Name & Degree
Amanda Vest, MBBS MPH
First Name & Middle Initial & Last Name & Degree
Michele Esposito, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Food As Medicine for Heart Failure

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