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Completed

NCT Number: NCT03990311

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

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.

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Key information

Conditions

Hypertension in Dialysis Patients Fluid Overload in Dialysis Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Sodium Restricted Meals

Other

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

Other names: Dietary Counseling

Control

Other

Usual Care

Primary outcomes

  1. Change in Interdialytic Weight Gain throughout Length of Study

    Time frame: 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 outcomes

  1. Rate of Intradialytic Hypotension Episodes throughout Length of Study

    Time frame: Every two weeks starting at baseline and through 5months (Control Arm)/ 7 months (intervention arm)

    Intradialytic Systolic BP <90 mm Hg

Other outcomes

  1. Pre-dialysis Blood Pressure

    Time frame: through 5months (intervention arm)/ 7 months (control arm)

    BP measurement prior to dialysis, taken for HD patients at each session

  2. Salt Taste Perception

    Time frame: through 5months (intervention arm)/ 7 months (control arm)

    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".

  3. Salt Taste Preference

    Time frame: through 5months (intervention arm)/ 7 months (control arm)

    Testing salty solution taste preference via sip, swish, and spit and, in the opinion of the participant, selecting which solution tasted better.

  4. Fluid Overload

    Time frame: through 5months (intervention arm)/ 7 months (control arm)

    As defined by lung U/S at the end of the dialysis treatment

  5. Rate of Achievement of Estimated Dry Weight

    Time frame: through 5months (intervention arm)/ 7 months (control arm)

    Post-weight not greater than EDW by 0.5 kg

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Acronym: PEPPERDISH

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 18, 2019
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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