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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
12 weeks of home-delivered MTMs, delivered weekly, containing food for 3 meals per day on 5 days of the week
12 weeks of 1 bottle of Ensure Max Protein shake every day, in addition to partcipants' standard diet
Tufts Medical Center
Boston, Massachusetts, United States
Kansas City Cardiomyopathy Questionnaire (KCCQ)
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
Handgrip strength measurement in kg
Upper extremity strength measured by dynamometer (higher kg achieved indicates greater strength)
Time frame: Change from start to end of 12-week MTM period
Sit-to-stand test
Lower extremity strength measure (lower time indicates greater strength)
Time frame: Change from start to end of 12-week MTM period
6 minute walk test
Strength and endurance measure
Time frame: Change from start to end of 12-week MTM period
Diet Satisfaction scale (DSat-28)
Dietary satisfaction measure
Time frame: Change from start to end of 12-week MTM period
Short Nutritional Assessment Questionnaire (SNAQ)
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
Facilitated food recall
3-day 24-hour facilitated food recall
Time frame: Change from start to end of 12-week MTM period
Weight
Subject's body weight, measured on standing scale
Time frame: Change from start to end of 12-week MTM period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.