MalnutritionNCT03412695
Development of a Decision Support System to Prevent and Treat Disease-related Malnutrition
A study testing MyFood in people with Malnutrition, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The prevalence of disease-related malnutrition among hospitalized patients is 30-50%. There is a lack of tools to follow up the nutritional treatment of these patients. The investigators develop the decision support system "MyFood" which can be used to assess patients' dietary intake, evaluate intake against… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- MyFood
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 22 Aug 2018to 31 May 2019
- 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
None listed.
Who cannot join
- <72 hours expected hospital stay
- Terminal patients
- Pregnant
- Psychiatric patients
- Patients who cannot read the Norwegian Language
- Patients diagnosed with: sickle cell anemia, haemophilia, or deep vein thrombosis
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of disease-related malnutrition among hospitalized patients is 30-50%. There is a lack of tools to follow up the nutritional treatment of these patients. The investigators develop the decision support system "MyFood" which can be used to assess patients' dietary intake, evaluate intake against individual needs, and propose nutrition related measures and an individual nutrition plan for each patient. The investigators will study the clinical effects of using MyFood among hospitalized patients. In addition the implementation of the tool among healthcare workers will be studied.
Read the detailed description
The prevalence of disease-related malnutrition among hospitalized patients is 30-50%. Disease-related malnutrition increase the morbidity and mortality among patients and leads to longer length of stay. There is a lack of tools to follow up the nutritional treatment of patients at nutritional risk. The decision support system "MyFood" is developed in the project with the purpose to prevent and treat disease-related malnutrition. MyFood includes 4 modules: 1) A function to register patient needs and symptoms, 2) Dietary assessment function, 3) Automatic evaluation of dietary intake compared to individual needs, 4) Feedback, including a report on intake of energy, protein, and liquids compared to individual needs, and recommendations for nutritional measures and an individual nutrition plan.
Clinical effects of using MyFood among hospitalized patients will be studied in a randomized controlled trial. In addition, the implementation of the tool among nurses and other healthcare workers will be explored.
- Conditions
- Malnutrition
- Being tested
- MyFood
- Keywords
- Disease-related malnutrition, eHealth, Decision support system, Clinical nutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyFoodDevice
Patients included in the intervention group will use the MyFood app to record their dietary intake. Nurses will use the report and recommendations in the MyFood tool to follow up the nutritional treatment of the patients.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Use of the MyFood tool among patients and nurses (intervention group) Receives: Device: MyFood |
| Arm B | No intervention | No intervention. Regular hospital routines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight (kg) during hospital stay
Measured standing on an electronic scale
Measured: 2 times each week, from patient admission (day 1) to hospital discharge (on average day 11)
Secondary outcomes (7)
Patient length of hospital stay
Length of hospital stay (LOS) will be measured for all participating patients. Average LOS in the intervention group will be compared with the average LOS in the control group
Measured: At the day of patient discharge (on day 11)
Change in body Composition
Fat free mass, muscle mass, fat mass, and phase angle. Measured by bioelectrical impedance analysis.
Measured: 2 times each week, from patient admission (day 1) to hospital discharge (on average day 11)
Proportion of patients who receives a nutrition diagnose
Number of patients who receives a nutrition diagnose (E46.00) will be measured among patients participating in the study. Proportion of patients who receives a nutrition diagnose in the intervention group will be compared with the proportion of patients who receives a nutrition diagnose in the control group.
Measured: Assessed from medical journals every second day during each patient's hospital stay (11 days on average)
Proportion of patients who get implemented nutrition-related measures
The decision support system gives recommendations for nutritional-related measures, based on individual symptoms and dietary intake compared to needs.
Measured: Assessed from medical journals every second day during each patient's hospital stay (11 days on average)
Proportion of patients who receive a nutrition plan
According to the national guidelines all patients at nutritional risk should have an individual nutrition plan. The decision support system will generate a suggested nutrition plan, based on information recorded in the system. Proportion of patients in the intervention group who receives a nutrition plan, compared to proportion in the control group will be measured
Measured: Assessed from the participating patients' medical journals on day 2 and every second day during hospital stay (11 days on average)
Re-admissions
Unplanned re-admissions
Measured: 30 days after discharge
Patient generated subjective global assessment (PG-SGA) score
The patient generated subjective global assessment (PG-SGA) is a form including questions on weight development, food intake, symptoms, and activity level and function
Measured: Measured on day 1 and at admission (day 11 on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start22 Aug 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Mari Mohn Paulsen, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412695
- Sponsor's protocol ID
- 2016/1464
- Status last verified
- Jul 2019
- First submitted
- 10 Jan 2018
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paulsen MM, Varsi C, Andersen LF. Process evaluation of the implementation of a decision support system to prevent and treat disease-related malnutrition in a hospital setting. BMC Health Serv Res. 2021 Mar 25;21(1):281. doi: 10.1186/s12913-021-06236-3.
PubMed 33766017Paulsen MM, Paur I, Gjestland J, Henriksen C, Varsi C, Tangvik RJ, Andersen LF. Effects of using the MyFood decision support system on hospitalized patients' nutritional status and treatment: A randomized controlled trial. Clin Nutr. 2020 Dec;39(12):3607-3617. doi: 10.1016/j.clnu.2020.03.012. Epub 2020 Mar 19.
PubMed 32241711
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Decision Support System to Prevent and Treat Disease-related Malnutrition
- ClinicalTrials.gov ID
- NCT03412695
- Acronym / sponsor ID
- 2016/1464
- Conditions
- Malnutrition
- Keywords
- Disease-related malnutrition, eHealth, Decision support system, Clinical nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 26 Jan 2018 (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 prevalence of disease-related malnutrition among hospitalized patients is 30-50%. There is a lack of tools to follow up the nutritional treatment of these patients. The investigators develop the decision support system "MyFood" which can be used to assess patients' dietary intake, evaluate intake against individual needs, and propose nutrition related measures and an individual nutrition plan for each patient. The investigators will study the clinical effects of using MyFood among hospitalized patients. In addition the implementation of the tool among healthcare workers will be studied.
Detailed description
The prevalence of disease-related malnutrition among hospitalized patients is 30-50%. Disease-related malnutrition increase the morbidity and mortality among patients and leads to longer length of stay. There is a lack of tools to follow up the nutritional treatment of patients at nutritional risk. The decision support system "MyFood" is developed in the project with the purpose to prevent and treat disease-related malnutrition. MyFood includes 4 modules: 1) A function to register patient needs and symptoms, 2) Dietary assessment function, 3) Automatic evaluation of dietary intake compared to individual needs, 4) Feedback, including a report on intake of energy, protein, and liquids compared to individual needs, and recommendations for nutritional measures and an individual nutrition plan.
Clinical effects of using MyFood among hospitalized patients will be studied in a randomized controlled trial. In addition, the implementation of the tool among nurses and other healthcare workers will be explored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Device: MyFoodUse of the MyFood tool among patients and nurses (intervention group) |
| Arm B | No intervention | –No intervention. Regular hospital routines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- <72 hours expected hospital stay
- Terminal patients
- Pregnant
- Psychiatric patients
- Patients who cannot read the Norwegian Language
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 |
|---|---|---|
| MyFoodPatients included in the intervention group will use the MyFood app to record their dietary intake. Nurses will use the report and recommendations in the MyFood tool to follow up the nutritional treatment of the patients. | Device | Arm A |
Primary outcome
Change in body weight (kg) during hospital stay
Time frame: 2 times each week, from patient admission (day 1) to hospital discharge (on average day 11)
Measured standing on an electronic scale
7 secondary outcomes
Patient length of hospital stay
Time frame: At the day of patient discharge (on day 11)
Change in body Composition
Time frame: 2 times each week, from patient admission (day 1) to hospital discharge (on average day 11)
Proportion of patients who receives a nutrition diagnose
Time frame: Assessed from medical journals every second day during each patient's hospital stay (11 days on average)
Proportion of patients who get implemented nutrition-related measures
Time frame: Assessed from medical journals every second day during each patient's hospital stay (11 days on average)
Proportion of patients who receive a nutrition plan
Time frame: Assessed from the participating patients' medical journals on day 2 and every second day during hospital stay (11 days on average)
Re-admissions
Time frame: 30 days after discharge
Patient generated subjective global assessment (PG-SGA) score
Time frame: Measured on day 1 and at admission (day 11 on average)
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 31 Jul 2019.
- Derived from this study: PubMed 33766017Paulsen MM, Varsi C, Andersen LF. Process evaluation of the implementation of a decision support system to prevent and treat disease-related malnutrition in a hospital setting. BMC Health Serv Res. 2021 Mar 25;21(1):281. doi: 10.1186/s12913-021-06236-3.
- Derived from this study: PubMed 32241711Paulsen MM, Paur I, Gjestland J, Henriksen C, Varsi C, Tangvik RJ, Andersen LF. Effects of using the MyFood decision support system on hospitalized patients' nutritional status and treatment: A randomized controlled trial. Clin Nutr. 2020 Dec;39(12):3607-3617. doi: 10.1016/j.clnu.2020.03.012. Epub 2020 Mar 19.
- Individual participant dataSharing planned: No
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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 MyFood in people with Malnutrition, run by Oslo University Hospital at 1 site in Norway.
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 0 inclusion and 6 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 31 Jul 2019. 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 Norway. 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?
Change in body weight (kg) during hospital stay (time frame: 2 times each week, from patient admission (day 1) to hospital discharge (on average day 11)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03412695, which also lists 2 linked publications.
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 31 Jul 2019.