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

NCT ID: NCT03990311

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-05
• Study Completion Date: 2021-12-31

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.

Conditions

Hypertension in Dialysis Patients; Fluid Overload in Dialysis Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Sodium Restricted Meals

Intervention Type: 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

Control

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

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

Usual Care

Interventions

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

Intervention Type: OTHER

Control

Usual Care

Intervention Type: OTHER

Other Intervention Names

Dietary Counseling

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

999

Identifier Type: -

Identifier Source: org_study_id