- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05860140
Preventing Malnutrition Among Older Adults
March 19, 2024 updated by: Monica Christin Hansen, Nord University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bodø, Norway, 8020
- Monica Christin Hansen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients patients only receiving liquid diet such as tube feeding
- terminal-ill patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
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.
|
Six minutes long education video focusing on protein and energy meals
|
|
No Intervention: Control group
Control group, not given any intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Change in Health related quality of life Using Rand 36 Questionnaire after 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body fat
Time Frame: Change in Body mass index after 3 months
|
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.
|
Change in Body mass index after 3 months
|
|
Readmissions to hospital after discharge from the hospital
Time Frame: Registration of Readmissions 3 months after
|
Readmissions after discharge from the hospital will be meassured three months after discharge
|
Registration of Readmissions 3 months after
|
|
Muscle Strength
Time Frame: Change in Hand Grip Strength (muscle strenght) after 3 months
|
Measure Muscle Strength in kg using Saehan Hydraulic Hand Dynometer for Hand Grip strength in both hands.
|
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
|
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
|
Change in The mid-arm circumference after 3 months
|
|
Subcutaneous fat
Time Frame: Change in Subcutaneous fat after 3 months
|
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.
|
Change in Subcutaneous fat after 3 months
|
|
Muscle protein mass
Time Frame: Change in Muscle protein mass after 3 months
|
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)
|
Change in Muscle protein mass after 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Estimated)
April 20, 2026
Study Completion (Estimated)
June 6, 2026
Study Registration Dates
First Submitted
April 17, 2023
First Submitted That Met QC Criteria
May 5, 2023
First Posted (Actual)
May 16, 2023
Study Record Updates
Last Update Posted (Actual)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 19, 2024
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 366924
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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