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

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

Sponsors

Lead Sponsor: Tufts Medical Center

Source Tufts Medical Center
Brief Summary

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

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.

Overall Status Active, not recruiting
Start Date June 5, 2019
Completion Date March 2021
Primary Completion Date December 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Interdialytic Weight Gain throughout Length of Study Every two weeks starting through 5months (intervention arm)/ 7 months (control arm)
Secondary Outcome
Measure Time Frame
Rate of Intradialytic Hypotension Episodes throughout Length of Study Every two weeks starting at baseline and through 5months (Control Arm)/ 7 months (intervention arm)
Enrollment 40
Condition
Intervention

Intervention Type: Other

Intervention Name: Sodium Restricted Meals

Description: 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

Arm Group Label: Intervention

Other Name: Dietary Counseling

Intervention Type: Other

Intervention Name: Control

Description: Usual Care

Arm Group Label: Control

Eligibility

Criteria:

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:

-

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility: Tufts Medical Center
Location Countries

United States

Verification Date

August 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Intervention

Type: Experimental

Description: The experimental arm receives 2 months of sodium restricted prepared meals plus dietary counseling followed by 3 months of counseling alone.

Label: Control

Type: Placebo Comparator

Description: The control arm receives 5 months of usual care followed by 2 months of receipt of sodium restricted prepared meals.

Acronym PEPPERDISH
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Sequential Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking Description: 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.

Source: ClinicalTrials.gov