MalnutritionNCT05860140
Preventing Malnutrition Among Older Adults
A study testing Education video in people with Malnutrition, run by Nord University at 1 site in Norway.
Trial summary
This project aims to explore 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 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Education video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteNorway
- Study dates
- 1 May 2022to 6 Jun 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Orthopedic and surgical in bedded patient patients in a selected regional hospital in Norway.
- Over 65 years old. Have their home address in one of nine selected municipalities in Nordland county.
- home living and due to return home after discharge directly from the hospital or after a short-term training stay at a training centre before returning home.
- Could read and understand Norwegian.
- Have consent competence.
- Have a Body mass index less than 24.
Who cannot join
- Patients patients only receiving liquid diet such as tube feeding
- terminal-ill patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention and Treatment of Malnutrition Among Home-living Older Adults Over 65 Years.
This project aims to explore 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, Disease-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 minutes long education video focusing on protein and energy meals
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | will get access to a six-minute educational video five days after being discharged from the hospital. The video is focusing on protein and energy meals for older adults. Receives: Other: Education video |
| Control group | No intervention | Control group, not 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 Questionnaire
Using Rand 36 Questionnaire
Measured: Change in Health related quality of life Using Rand 36 Questionnaire after 3 months
Secondary outcomes (6)
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/m^2.
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 meassured three months after discharge
Measured: Registration of Readmissions 3 months after
Muscle Strength
Measure Muscle Strength in kg using Saehan Hydraulic Hand Dynometer for Hand Grip strength in both hands.
Measured: Change in Hand Grip Strength (muscle strenght) after 3 months
The mid-arm circumference
The mid-arm circumference (MAC) will be measured in cm with a measuring tape. This will be done of the left upper arm measured at the midpoint between the tip of the shoulder and the tip of the elbow
Measured: Change in The mid-arm circumference after 3 months
Subcutaneous fat
Subcutaneous fat will be measured by Triceps skinfold thickness (TFS). This will be done by a in millimetres with a VirtuFits Digital Fat Caliper skinfold in the triceps of the left arm.
Measured: Change in Subcutaneous fat after 3 months
Muscle protein mass
Muscle protein mass will be measured by the mean arm muscle circumference (MAMC) calculated according to the formula: MAMC (cm) = MAC (cm) - (3,14 X TFS x 0,1)
Measured: Change in Muscle protein mass after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 May 2022
- Primary completion20 Apr 2026 (estimated)
- Study completion6 Jun 2026 (estimated)
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 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
- NCT05860140
- Sponsor's protocol ID
- 366924
- Status last verified
- Jun 2023
- First submitted
- 17 Apr 2023
- Last updated
- 20 Mar 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. The feasibility of an education video for preventing disease-related malnutrition among home-living older adults after discharge from a surgical hospital department - a randomised controlled feasibility trial. Pilot Feasibility Stud. 2025 Dec 5;12(1):6. doi: 10.1186/s40814-025-01745-y.
PubMed 41351135Hansen MC, Ingstad K, Uhrenfeldt L, Pedersen PU. Assessing the impact of a nutrition educational video on health-related quality of life in older home-living adults after discharge from a surgical hospital department: a randomised controlled pilot trial. BMC Nutr. 2025 Nov 25;11(1):230. doi: 10.1186/s40795-025-01203-1.
PubMed 41291959
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Treatment of Malnutrition Among Home-living Older Adults Over 65 Years.
- ClinicalTrials.gov ID
- NCT05860140
- Acronym / sponsor ID
- 366924
- Conditions
- Malnutrition
- Keywords
- older adults, Disease-related malnutrition, Educational video
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Nord UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 6 Jun 2026 (estimated)
- First posted
- 16 May 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 aims to explore 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Education videowill get access to a six-minute educational video five days after being discharged from the hospital. The video is focusing on protein and energy meals for older adults. |
| Control group | No intervention | –Control group, not given any intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Orthopedic and surgical in bedded patient patients in a selected regional hospital in Norway.
- Over 65 years old. Have their home address in one of nine selected municipalities in Nordland county.
- home living and due to return home after discharge directly from the hospital or after a short-term training stay at a training centre before returning home.
- Could read and understand Norwegian.
- Have consent competence.
Key exclusion criteria (2 listed)
- Patients patients only receiving liquid diet such as tube feeding
- terminal-ill patients
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 minutes long education video focusing on protein and energy meals | Other | Intervention group |
Primary outcome
Health related quality of life Using Rand 36 Questionnaire
Time frame: Change in Health related quality of life Using Rand 36 Questionnaire after 3 months
Using Rand 36 Questionnaire
6 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 strenght) after 3 months
The mid-arm circumference
Time frame: Change in The mid-arm circumference after 3 months
Subcutaneous fat
Time frame: Change in Subcutaneous fat after 3 months
Muscle protein mass
Time frame: Change in Muscle protein mass after 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Derived from this study: PubMed 41351135Hansen MC, Uhrenfeldt L, Ingstad K, Pedersen PU. The feasibility of an education video for preventing disease-related malnutrition among home-living older adults after discharge from a surgical hospital department - a randomised controlled feasibility trial. Pilot Feasibility Stud. 2025 Dec 5;12(1):6. doi: 10.1186/s40814-025-01745-y.
- Derived from this study: PubMed 41291959Hansen MC, Ingstad K, Uhrenfeldt L, Pedersen PU. Assessing the impact of a nutrition educational video on health-related quality of life in older home-living adults after discharge from a surgical hospital department: a randomised controlled pilot trial. BMC Nutr. 2025 Nov 25;11(1):230. doi: 10.1186/s40795-025-01203-1.
- 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 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 20 Mar 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?
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?
Health related quality of life Using Rand 36 Questionnaire (time frame: Change in Health related quality of life Using Rand 36 Questionnaire 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 NCT05860140, 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 20 Mar 2024.