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

Primary Purpose

Hypertension in Dialysis Patients, Fluid Overload in Dialysis Patients

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sodium Restricted Meals
Control
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension in Dialysis Patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of Intradialytic Hypotension Episodes throughout Length of Study
Intradialytic Systolic BP <90 mm Hg

Full Information

First Posted
February 4, 2019
Last Updated
January 17, 2023
Sponsor
Tufts Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03990311
Brief Title
Prepared Meals to Prime and Perpetuate Reduced Dietary Sodium Intake in Hemodialysis
Acronym
PEPPERDISH
Official Title
Prepared Meals to Prime and Perpetuate Reduced Dietary Sodium Intake in Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 5, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Dialysis Patients, Fluid Overload in Dialysis Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The experimental arm receives 2 months of sodium restricted prepared meals plus dietary counseling followed by 3 months of counseling alone.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The control arm receives 5 months of usual care followed by 2 months of receipt of sodium restricted prepared meals.
Intervention Type
Other
Intervention Name(s)
Sodium Restricted Meals
Other Intervention Name(s)
Dietary Counseling
Intervention 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
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Usual Care
Primary Outcome Measure Information:
Title
Change in Interdialytic Weight Gain throughout Length of Study
Description
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 Outcome Measure Information:
Title
Rate of Intradialytic Hypotension Episodes throughout Length of Study
Description
Intradialytic Systolic BP <90 mm Hg
Time Frame
Every two weeks starting at baseline and through 5months (Control Arm)/ 7 months (intervention arm)
Other Pre-specified Outcome Measures:
Title
Pre-dialysis Blood Pressure
Description
BP measurement prior to dialysis, taken for HD patients at each session
Time Frame
through 5months (intervention arm)/ 7 months (control arm)
Title
Salt Taste Perception
Description
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".
Time Frame
through 5months (intervention arm)/ 7 months (control arm)
Title
Salt Taste Preference
Description
Testing salty solution taste preference via sip, swish, and spit and, in the opinion of the participant, selecting which solution tasted better.
Time Frame
through 5months (intervention arm)/ 7 months (control arm)
Title
Fluid Overload
Description
As defined by lung U/S at the end of the dialysis treatment
Time Frame
through 5months (intervention arm)/ 7 months (control arm)
Title
Rate of Achievement of Estimated Dry Weight
Description
Post-weight not greater than EDW by 0.5 kg
Time Frame
through 5months (intervention arm)/ 7 months (control arm)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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