Give a MANNA a Fish, Teach a MANNA to Fish

NCT03969199 | Withdrawn

• 1 other identifier: 829424
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a randomized pilot seeking to address low patient adherence to a low sodium diet as a strategy to improve outcomes of patients with cirrhosis of the liver. In coordination with the Metropolitan Area Neighborhood Nutrition Alliance (MANNA) of Philadelphia, patients in the intervention cohort will receive low sodium MANNA meals to encourage improved dietary compliance. Outcomes of these interventional patients will be compared to those receiving standard of care--namely, educational intervention by physicians supplemented by occasional counseling from dieticians during clinic visits encouraging a low sodium diet. Dietary compliance will be evaluated by urine sodium and salt affinity tests and used as a positive marker for improved outcomes. The target population of this study is patients diagnosed with cirrhosis of the liver, aged 18-85 years living within the MANNA-serviced area.

Conditions

Cirrhosis, Liver; Liver Diseases; Malnutrition

Keywords

MANNA; Nutrition; Cirrhosis, Liver; Liver Diseases; Dietary compliance; Low sodium diet; Non-profit; Salt affinity; Behavioral changes

Outcome Measures

Primary Outcomes (1)

• Differential adherence to a low sodium diet during intervention

  A measurable difference in dietary compliance during participation in the MANNA meal program. Compliance will be assessed by performing urine sodium analyses coupled with salt affinity tests following the first 90 days of the study.

  90 days

Secondary Outcomes (1)

• Sustained differential adherence to low sodium diet following intervention

  180 days

Study Arms (2)

MANNA Food Delivery Service

EXPERIMENTAL

MANNA will deliver meals to patients randomized to the intervention arm of the study every week on the same day for 90 days. Each delivery will include: 7 breakfast meals, 7 lunch meals, 7 dinner entrees, health desserts, and fresh fruit. Meals will be delivered frozen and can be stored in a freezer until ready to eat. Patients will be followed for 180 days and will be assessed for their salt affinity and urine sodium at 3 separate time points throughout the study: baseline, 90 days, and 180 days.

Behavioral: Intervention

Standard of Care Counseling

NO INTERVENTION

Patients randomized to the control arm will receive standard or care dietary counseling from either their physician or a dietician. Patients will be followed for 180 days and will be assessed for their salt affinity and urine sodium at 3 separate time points throughout the study: baseline, 90 days, and 180 days.

Interventions

Intervention BEHAVIORAL

Dietary intervention in coordination with MANNA, who will deliver low sodium meals to patients for 90 days

MANNA Food Delivery Service

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with cirrhosis of the liver
• to 85 years old
• Ability to read and provide informed consent
• Resides in an area serviced by MANNA
• Has a medical need for restriction of dietary sodium

You may not qualify if:

• Unclear diagnosis of cirrhosis of the liver
• Inability to provide informed consent
• Any other reason for which the investigator feels the participant would be unable to safely follow the study protocol.
• Resides in an area not serviced by MANNA
• Nutritional needs that cannot be accommodated by MANNA (i.e. vegan or vegetarian, nut-free, gluten-free, Kosher, Macrobiotics and/or allergy to milk, eggs, soybean, peanuts, tree nuts, fish and shellfish.

Sponsors & Collaborators

• University of Pennsylvania: lead

MeSH Terms

Conditions

Liver Cirrhosis; Liver Diseases; Malnutrition

Interventions

Methods

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 31, 2019
• Study Start: December 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: July 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01