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

NCT03990311 | Completed

• 1 other identifier: 999
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension in Dialysis Patients; Fluid Overload in Dialysis Patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of Intradialytic Hypotension Episodes throughout Length of Study

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

Other Outcomes (5)

• Pre-dialysis Blood Pressure

  through 5months (intervention arm)/ 7 months (control arm)

• Salt Taste Perception

  through 5months (intervention arm)/ 7 months (control arm)

• Salt Taste Preference

  through 5months (intervention arm)/ 7 months (control arm)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Sodium Restricted Meals

Control

PLACEBO COMPARATOR

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

Other: Control

Interventions

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

Also known as: Dietary Counseling

Intervention

Control OTHER

Usual Care

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: BP, weight, IDH (as defined by an intra-or post dialysis BP \<90 mmHg) will be recorded per usual clinical care by the dialysis unit staff. Patients will be blinded to the salinity of the salt solutions used to test taste perception and preference.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: June 18, 2019
• Study Start: June 5, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)