Prepared Meals to Prime and Perpetuate Reduced Dietary Sodium Intake in Hemodialysis

Tufts Medical Center40 enrolled

Overview

This is a randomized clinical trial in which maintenance hemodialysis patients will be provided with salt restricted 'dialysis friendly' meals and compared to a control arm receiving usual care.

Patients randomized to the intervention arm will receive 2 months of meals plus dietary counseling. Counseling will continue for an additional 3 months while the control arm will have 5 months of usual care followed by 2 months of meal provision. Effects on interdialytic weight gain, achievement of target dry weight, intradialytic hypotension episodes, blood pressure, and a volume assessment using lung U/S to assess lung water will be measured. Salt sensitivity will be tested throughout the study. Self reported questionnaires about the burden of adhering to the low salt diet and the level of adherence with it will be completed at baseline and throughout the study. The investigator hypothesizes that the prepared meals with prime patients behavior and may alter salt taste perception and that these effects will be sustained after the prepared meals have stopped.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hypertension in Dialysis Patients Fluid Overload in Dialysis Patients

Interventions

Sodium Restricted MealsOTHER

2 meals prepared with 2 g /day sodium restriction and adhering to dietary recommendations for a hemodialysis patients (phosphate and potassium restricted/ high protein content) 2 meals per day for first month of meal provision period followed by 1 meal per month in the second meal of meal provision period

ControlOTHER

Usual Care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \>18 2. Treated with outpatient hemodialysis for \>60 days 3. Mean IDWG over the past 30 days \>2 kg 4. Speaks and understands English or Chinese 5. Patient has a freezer at home with space to store at least 7 prepared meals 6. Cognitively intact (able to provide informed consent and answer questionnaires) Exclusion Criteria: \-

Locations (1)

Tufts Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change in Interdialytic Weight Gain throughout Length of Study

A standard measurement taken for HD patients at each dialysis session to see weight gained between sessions

Time frame: Every two weeks starting through 5months (intervention arm)/ 7 months (control arm)

Secondary Outcomes

Rate of Intradialytic Hypotension Episodes throughout Length of Study

Intradialytic Systolic BP \<90 mm Hg

Time frame: Every two weeks starting at baseline and through 5months (Control Arm)/ 7 months (intervention arm)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.