MalnutritionNCT05950373
Educational Intervention for Better Nutrition to Preserve Functionality - Design of a Randomised Clinical Trial
A study testing Education video in people with Malnutrition, run by Nord University at 1 site in Norway.
Trial summary
This project explores whether access to a digital education video can improve the nutritional situation of home-living older adults after being discharged from the hospital. Read more about this study
- Who is it for?
- Ages 65 to 110 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- Education video
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2025to 1 Oct 2026
- 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 65 to 110 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Surgical patients embedded in a regional hospital.
- Home-living in one of nine selected municipalities.
- Be able to read and understand Norwegian.
- Have a consent competence.
- Have a body mass index < 24.
- Have access to a digital solution such as a tablet or phone.
Who cannot join
- Persons given only a liquid diet.
- Persons in a terminally ill phase.
Trial locations and contacts
1 site in 1 country.
About this study
This project explores whether access to a digital education video can improve the nutritional situation of home-living older adults after being discharged from the hospital.
- Conditions
- Malnutrition
- Being tested
- Education video
- Keywords
- Older adults, Diseases-related malnutrition, Educational video
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education videoOther
six minute long education video focusing on protein and energy meals for older adults.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The Intervention group will get access to a six-minute long education video five days after being discharges from the hospital. The video is focusing on protein and energy meals for older adults.
The educational film is available via a link on a tablet/ computer or mobile phone.
The education video vil only be given one time. Receives: Other: Education video |
| Control group | No intervention | The control group will not be given any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life Using Rand 36 questionaire
Using Rand 36 questionaire. The data from the SF-36 ordinal subscales will be transformed to a ratio scale using the syntax SF-36 manual and will be presented as the results from each of the eight subscales and the two main scales
Measured: Change in Health related quality of life Using Rand 36 questionaire after 3 months
Secondary outcomes (7)
Body fat
Body fat will be measured by Body mass index (BMI). Weight (in kg) and height (in cm) will be combined to report BMI in Kg/m2
Measured: Change in Body mass index after 3 months.
Readmissions to hospital after discharge from the hospital
Readmissions after discharge from the hospital will be measured three months after discharge.
Measured: Registration of Readmissions 3 months after
Muscle strength
Measure Muscle Strength (in Kg) using Hydraulic Hand dynameter for Hand Grip strength in both hands.
Measured: Change in Hand Grip Strength (muscle strength) after 3 months
The mid-arm circumferences
The mid-arm circumferences (MAC) will be measured in cm with a measuring tape. This will be done on the left upper arm measured at the midpoint between the top of the shoulder and the tip of the elbow.
Measured: Change in the mid-arm cirumferences after three months.
Subcutaneous fat
Subcutaneous fat will be measured by Triceps skinfold thickness (TFS). This will be done in millimetres with a VirtuFits Digital Fat caliper skinfold in the triceps of the left arm.
Measured: Change in Subcutaneous fat after three months.
Muscle protein mass
Muscle protein mass will be measured by the mean arm muscle circumferences (MAMC) calculated to the formula: MAMC (cm) = MAC (cm) - (3,14 X TFS X 0,1)
Measured: Change in Muscle protein mass after 3 months
Knowledge about nutrition
Participants' knowledge about nutrition will be measured with a questionaire consisting of three questions related to the education video.
Measured: Registration in a questionaire three months after discharge from the hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Jan 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nord University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Christin Hansen, Nord University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950373
- Sponsor's protocol ID
- 366925
- Status last verified
- Apr 2024
- First submitted
- 11 Jul 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hansen MC, Uhrenfeldt L, Ingstad K, Pedersen PU. Educational nutritional intervention to prevent loss of health-related quality of life among older adults after a surgical treatment: design of a randomised controlled trial. Trials. 2024 Apr 15;25(1):262. doi: 10.1186/s13063-024-08096-8.
PubMed 38622729
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Intervention for Better Nutrition to Preserve Functionality - Design of a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT05950373
- Acronym / sponsor ID
- 366925
- Conditions
- Malnutrition
- Keywords
- Older adults, Diseases-related malnutrition, Educational video
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Nord UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 18 Jul 2023 (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.
This project explores whether access to a digital education video can improve the nutritional situation of home-living older adults after being discharged from the hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Education videoThe Intervention group will get access to a six-minute long education video five days after being discharges from the hospital. The video is focusing on protein and energy meals for older adults. The educational film is available via a link on a tablet/ computer or mobile phone. The education video vil only be given one time. |
| Control group | No intervention | –The control group will not be given any intervention. |
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Surgical patients embedded in a regional hospital.
- Home-living in one of nine selected municipalities.
- Be able to read and understand Norwegian.
- Have a consent competence.
- Have a body mass index < 24.
Key exclusion criteria (2 listed)
- Persons given only a liquid diet.
- Persons in a terminally ill phase.
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 |
|---|---|---|
| Education videosix minute long education video focusing on protein and energy meals for older adults. | Other | Intervention group |
Primary outcome
Health related quality of life Using Rand 36 questionaire
Time frame: Change in Health related quality of life Using Rand 36 questionaire after 3 months
Using Rand 36 questionaire. The data from the SF-36 ordinal subscales will be transformed to a ratio scale using the syntax SF-36 manual and will be presented as the results from each of the eight subscales and the two main scales
7 secondary outcomes
Body fat
Time frame: Change in Body mass index after 3 months.
Readmissions to hospital after discharge from the hospital
Time frame: Registration of Readmissions 3 months after
Muscle strength
Time frame: Change in Hand Grip Strength (muscle strength) after 3 months
The mid-arm circumferences
Time frame: Change in the mid-arm cirumferences after three months.
Subcutaneous fat
Time frame: Change in Subcutaneous fat after three months.
Muscle protein mass
Time frame: Change in Muscle protein mass after 3 months
Knowledge about nutrition
Time frame: Registration in a questionaire three months after discharge from the hospital.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Derived from this study: PubMed 38622729Hansen MC, Uhrenfeldt L, Ingstad K, Pedersen PU. Educational nutritional intervention to prevent loss of health-related quality of life among older adults after a surgical treatment: design of a randomised controlled trial. Trials. 2024 Apr 15;25(1):262. doi: 10.1186/s13063-024-08096-8.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education video in people with Malnutrition, run by Nord University 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monica Hansen, Master (0047 75517250, monica.c.hansen@nord.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life Using Rand 36 questionaire (time frame: Change in Health related quality of life Using Rand 36 questionaire after 3 months). 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 NCT05950373, which also lists 1 linked publication.
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 3 Apr 2024.