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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The experimental arm receives 2 months of sodium restricted prepared meals plus dietary counseling followed by 3 months of counseling alone. |
|
| Control | Placebo Comparator | The control arm receives 5 months of usual care followed by 2 months of receipt of sodium restricted prepared meals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Restricted Meals | Other | 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 |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-dialysis Blood Pressure | BP measurement prior to dialysis, taken for HD patients at each session | through 5months (intervention arm)/ 7 months (control arm) |
| Salt Taste Perception | Testing salty solution taste perception via sip, swish, and spit and rating saltiness on a general Labeled Magnitude Scale ranging from "Barely Detectable" to "Strongest Imaginable". |
Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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BP, weight, IDH (as defined by an intra-or post dialysis BP <90 mmHg) will be recorded per usual clinical care by the dialysis unit staff.
Patients will be blinded to the salinity of the salt solutions used to test taste perception and preference.
|
|
| Control | Other | Usual Care |
|
| through 5months (intervention arm)/ 7 months (control arm) |
| Salt Taste Preference | Testing salty solution taste preference via sip, swish, and spit and, in the opinion of the participant, selecting which solution tasted better. | through 5months (intervention arm)/ 7 months (control arm) |
| Fluid Overload | As defined by lung U/S at the end of the dialysis treatment | through 5months (intervention arm)/ 7 months (control arm) |
| Rate of Achievement of Estimated Dry Weight | Post-weight not greater than EDW by 0.5 kg | through 5months (intervention arm)/ 7 months (control arm) |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |