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

Tufts University

Status: Completed

Conditions: Hypertension in Dialysis Patients; Fluid Overload in Dialysis Patients

Treatments: Other: Sodium Restricted Meals; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03990311

999

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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

Treatment:

Other: Sodium Restricted Meals

Control

Placebo Comparator group

Description:

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

Treatment:

Other: Control