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

Fluid Overload in Dialysis Patients Clinical Trial

— PEPPERDISH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03990311
• Other study ID #: 999
• Status: Completed
• Phase: N/A
• Start date: June 5, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2023
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Fluid Overload in Dialysis Patients
• Hypertension
• Hypertension in Dialysis Patients

Intervention

Other:
• Sodium Restricted Meals
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
• Control
Usual Care

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pre-dialysis Blood Pressure	BP measurement prior to dialysis, taken for HD patients at each session	through 5months (intervention arm)/ 7 months (control arm)
Other	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".	through 5months (intervention arm)/ 7 months (control arm)
Other	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)
Other	Fluid Overload	As defined by lung U/S at the end of the dialysis treatment	through 5months (intervention arm)/ 7 months (control arm)
Other	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)
Primary	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	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)