CirrhosisNCT07090447
Evaluation of a Nutrition Education Guide for Patients With Cirrhosis
A study testing Nutrition in Cirrhosis guide in people with Cirrhosis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Nutrition in Cirrhosis guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- 4 Feb 2021to 13 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cirrhosis diagnosis documented by biopsy, radiological evidence, elastrography or decompensation event (such as hepatic encephalopathy, ascites and gastro-oesophageal bleeding)
- having access to Internet
Who cannot join
- non-french speaking
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche du Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9
About this study
Official title: Evaluation of a Nutrition Education Guide for Patients With Chronic Liver Disease: Impact on the Patient and Caregiver
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.
Read the detailed description
In this study, the investigators aimed to evaluate the impact of the Nutrition in Cirrhosis guide, an evidence-based educational resource created by a team of experts in Canada. The Guide was conceived in order to inform patients and help them follow nutritional guidelines for cirrhosis, which has been shown to be a challenge. Specifically, this study aimed to evaluate the impact of the Guide on patients' nutritional knowledge, quality of life and nutritional risk over a 6-month period, as well as changes in dietary intake. Secondly, the goal was to evaluate patients' satisfaction of the Guide using focus groups. In this randomized controlled mixed-methods study conducted at the Centre Hospitalier de l'Université de Montréal Research Center, patients in the intervention group (Guide+) received and used the Guide for 6 months, and a control group (Guide-) received standard of care. Data was collected at baseline, 3 months and 6 months.
- Conditions
- Cirrhosis
- Being tested
- Nutrition in Cirrhosis guide
- Keywords
- nutrition education, cirrhosis, education strategy, nutrition guide
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition in Cirrhosis guideBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Guide+ | Experimental | Participants who received and used the Nutrition in Cirrhosis guide Receives: Behavioral: Nutrition in Cirrhosis guide |
| Guide- | No intervention | Participants who received standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of intervention at 6 months
Secondary outcomes (4)
Health-related quality of life
Patients' quality of life was assessed using the Chronic Liver Disease Questionnaire (CLDQ), a validated tool specific for patients living with chronic liver disease. This questionnaire consists of 29 items categorized into 6 domains: abdominal symptoms, activity, emotional function, fatigue, systemic symptoms, and worry. Each domain is scored on a scale from 1 (indicating severe impact) to 7 (indicating minimal impact), with higher scores reflecting a lower frequency of symptoms and, therefore, an improved health-related QoL. The overall score is obtained by calculating the average of the 29 items.
Measured: From enrollment to the end of intervention at 6 months
Nutritional risk
The nutritional risk was evaluated using the Liver Disease Undernutrition Screening Tool (LDUST). The LDUST is an easy-to-use tool that allows patients to answer questions about the 6 components of the Malnutrition Identification Table, which is the consensus of the Academy of Nutrition and Dietetics and the American Society for Parenteral and Enteral Nutrition.
Measured: From enrollment to the end of intervention at 6 months
Dietary intakes
Dietary intakes were assessed using a validated, web-based, self-administered 24h dietary recall (R24W) developed at Université Laval (Québec, Canada). Participants were invited by email to complete the R24W on 2 unannounced days (1 weekend day and 1 weekday) selected randomly by a computer algorithm over a 7-day period, at every data collection timepoint.
Measured: From enrollment to the end of intervention at 6 months
Satisfaction with the Guide
Three online focus groups were conducted between August 2022 and October 2024. To be eligible, participants had to be in the Guide+ group. Each focus group was of an average duration of one hour and included 2 to 4 patients along with a patient partner to ensure the patients felt at ease and to facilitate the discussion. Focus groups were conducted by the registered dietitian on the Zoom meetings platform. Discussions were semi-directed based on an interview Guide that was developed by the research team prior to sessions and approved by the ethics committee. The interview Guide covered various sections, namely patients' overall satisfaction, their opinion on the Guide's complexity and its daily applicability.
Measured: At the end of the 6-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start4 Feb 2021
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090447
- Sponsor's protocol ID
- 20.189
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Nutrition Education Guide for Patients With Chronic Liver Disease: Impact on the Patient and Caregiver
- ClinicalTrials.gov ID
- NCT07090447
- Acronym / sponsor ID
- 20.189
- Conditions
- Cirrhosis
- Keywords
- nutrition education, cirrhosis, education strategy, nutrition guide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, the investigators aimed to evaluate the impact of the Nutrition in Cirrhosis guide, an evidence-based educational resource created by a team of experts in Canada. The Guide was conceived in order to inform patients and help them follow nutritional guidelines for cirrhosis, which has been shown to be a challenge. Specifically, this study aimed to evaluate the impact of the Guide on patients' nutritional knowledge, quality of life and nutritional risk over a 6-month period, as well as changes in dietary intake. Secondly, the goal was to evaluate patients' satisfaction of the Guide using focus groups. In this randomized controlled mixed-methods study conducted at the Centre Hospitalier de l'Université de Montréal Research Center, patients in the intervention group (Guide+) received and used the Guide for 6 months, and a control group (Guide-) received standard of care. Data was collected at baseline, 3 months and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guide+ | Experimental | Behavioral: Nutrition in Cirrhosis guideParticipants who received and used the Nutrition in Cirrhosis guide |
| Guide- | No intervention | –Participants who received standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- cirrhosis diagnosis documented by biopsy, radiological evidence, elastrography or decompensation event (such as hepatic encephalopathy, ascites and gastro-oesophageal bleeding)
- having access to Internet
Key exclusion criteria (1 listed)
- non-french speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition in Cirrhosis guidePatients 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. | Behavioural | Guide+ |
Primary outcome
Nutritional knowledge
Time frame: From enrollment to the end of intervention at 6 months
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.
4 secondary outcomes
Health-related quality of life
Time frame: From enrollment to the end of intervention at 6 months
Nutritional risk
Time frame: From enrollment to the end of intervention at 6 months
Dietary intakes
Time frame: From enrollment to the end of intervention at 6 months
Satisfaction with the Guide
Time frame: At the end of the 6-month intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- The Nutrition in Cirrhosis GuideLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition in Cirrhosis guide in people with Cirrhosis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional knowledge (time frame: From enrollment to the end of intervention at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.