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

Not Applicable

Completed

• Conditions: Hypertension in Dialysis Patients; Fluid Overload in Dialysis Patients
• Interventions: Other: Control; Other: Sodium Restricted Meals

• Registration Number: NCT03990311
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2019-02-04
• Study Start: 2019-06-05
• Study First Submitted QC: 2019-06-17
• Study First Posted: 2019-06-18
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Control	Control	The control arm receives 5 months of usual care followed by 2 months of receipt of sodium restricted prepared meals.
Intervention	Sodium Restricted Meals	The experimental arm receives 2 months of sodium restricted prepared meals plus dietary counseling followed by 3 months of counseling alone.

Primary Outcome Measures

Name	Time	Method
Change in Interdialytic Weight Gain throughout Length of Study	Every two weeks starting through 5months (intervention arm)/ 7 months (control arm)	A standard measurement taken for HD patients at each dialysis session to see weight gained between sessions

Secondary Outcome Measures

Name	Time	Method
Rate of Intradialytic Hypotension Episodes throughout Length of Study	Every two weeks starting at baseline and through 5months (Control Arm)/ 7 months (intervention arm)	Intradialytic Systolic BP \<90 mm Hg

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States