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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypertension in Dialysis Patients, Fluid Overload in Dialysis Patients

Intervention / Treatment
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* Other: Sodium Restricted Meals
* Other: Control


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The experimental arm receives 2 months of sodium restricted prepared meals plus dietary counseling followed by 3 months of counseling alone. | Other: Sodium Restricted Meals<br>* 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<br>* Other names: Dietary Counseling;|
| Placebo Comparator: Control<br>The control arm receives 5 months of usual care followed by 2 months of receipt of sodium restricted prepared meals. | Other: Control<br>* Usual Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Every two weeks starting through 5months (intervention arm)/ 7 months (control arm) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Intradialytic Hypotension Episodes throughout Length of Study | Intradialytic Systolic BP <90 mm Hg | Every two weeks starting at baseline and through 5months (Control Arm)/ 7 months (intervention arm) |