Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Heart Failure
  • Malnutrition
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The investigators plan to conduct a single-center, randomized pilot trial to assess the tolerability, feasibility, and efficacy of providing medically-tailored meals (MTMs) to patients with heart failure with reduced ejection fraction and malnutrition. The investigators hypothesize that MTMs will im...

The investigators plan to conduct a single-center, randomized pilot trial to assess the tolerability, feasibility, and efficacy of providing medically-tailored meals (MTMs) to patients with heart failure with reduced ejection fraction and malnutrition. The investigators hypothesize that MTMs will improve symptomatology, functional capacity, and serum biomarkers of heart failure in this patient population. There are two primary objectives for this pilot study: 1) confirm tolerability, feasibility, and efficacy of prescribing MTMs, 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, the investigators will test the following elements of this central hypothesis with 2 aims: Aim 1 Tolerability, feasibility, and efficacy of prescribing medically-tailored meals: 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.

Tracking Information

NCT #
NCT04847973
Collaborators
Community Servings
Investigators
Principal Investigator: Amanda Vest, MBBS MPH Tufts Medical Center