Evaluation of a Nutrition Education Guide for Patients With Cirrhosis

NCT07090447 | Completed

• 1 other identifier: 20.189
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective study is to evaluate the impact of the Nutrition in Cirrhosis guide in patients with chronic liver disease. Researchers compared the patients who received the Guide (Guide+ group) to the patients who received standard of care (Guide- group). Data collection occured at baseline, 3 and 6 months, and included evaluation of nutrition knowledge (questionnaire based on the Guide), quality of life (Chronic Liver Disease Questionnaire) and nutritional risk (Liver Disease Undernutrition Screening Tool). Satisfaction was evaluated with 3 focus groups including patients from the Guide+ group as well as a patient partner and thematic analysis was conducted.

Conditions

Cirrhosis

Keywords

nutrition education; cirrhosis; education strategy; nutrition guide

Outcome Measures

Primary Outcomes (1)

• Nutritional knowledge

  The assessment of participants' nutritional knowledge was conducted using a questionnaire created by experts from the research team with the intent to be solely based on the chapters of the Guide. The questionnaire consists of 14 items related to nutritional recommendations (dietary intake, protein, sodium, etc.), as well as questions regarding nutritional choices in the context of cirrhosis, definitions of nutritional terms, food groups and nutrients.

  From enrollment to the end of intervention at 6 months

Secondary Outcomes (4)

• Health-related quality of life

  From enrollment to the end of intervention at 6 months

• Nutritional risk

  From enrollment to the end of intervention at 6 months

• Dietary intakes

  From enrollment to the end of intervention at 6 months

• Satisfaction with the Guide

  At the end of the 6-month intervention

Study Arms (2)

Guide+

EXPERIMENTAL

Participants who received and used the Nutrition in Cirrhosis guide

Behavioral: Nutrition in Cirrhosis guide

Guide-

NO INTERVENTION

Participants who received standard of care

Interventions

Nutrition in Cirrhosis guide BEHAVIORAL

Patients in the intervention group received a paper copy of the Nutrition in Cirrhosis guide and were instructed to read and use it over the 6 months study period. The Nutrition in Cirrhosis guide consists 7 chapters, namely: Chapter 1: Malnutrition - What is it and why is it so important?; Chapter 2: What should patients eat and what to avoid?; Chapter 3: Tips for when patients do not feel like eating; Chapter 4: Recipe list; Chapter 5: Using meal supplements; Chapter 6: Managing weight loss and cirrhosis; Chapter 7: What to expect in the hospital.

Guide+

Eligibility Criteria

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

You may qualify if:

• cirrhosis diagnosis documented by biopsy, radiological evidence, elastrography or decompensation event (such as hepatic encephalopathy, ascites and gastro-oesophageal bleeding)
• having access to Internet

You may not qualify if:

• \- non-french speaking

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre de recherche du Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location

Related Links

• The Nutrition in Cirrhosis Guide

MeSH Terms

Conditions

Fibrosis

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

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: July 21, 2025
• First Posted: July 29, 2025
• Study Start: February 4, 2021
• Primary Completion: November 13, 2024
• Study Completion: November 13, 2024
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

CA (1)