Back to resultsEducational Intervention for Better Nutrition to Preserve Functionality - Design of a Randomised Clinical Trial
Primary Purpose
Malnutrition
Status
Not yet recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Education video
Sponsored by
About this trial
This is an interventional prevention trial for Malnutrition focused on measuring Older adults, Diseases-related malnutrition, Educational video
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Persons given only a liquid diet. Persons in a terminally ill phase.
Sites / Locations
- Monica Christin Hansen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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.
The control group will not be given any intervention.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Readmissions to hospital after discharge from the hospital
Readmissions after discharge from the hospital will be measured three months after discharge.
Muscle strength
Measure Muscle Strength (in Kg) using Hydraulic Hand dynameter for Hand Grip strength in both hands.
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.
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.
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)
Knowledge about nutrition
Participants' knowledge about nutrition will be measured with a questionaire consisting of three questions related to the education video.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05950373
Brief Title
Educational Intervention for Better Nutrition to Preserve Functionality - Design of a Randomised Clinical Trial
Official Title
Educational Intervention for Better Nutrition to Preserve Functionality - Design of a Randomised Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2025 (Anticipated)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nord University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Older adults, Diseases-related malnutrition, Educational video
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will not be given any intervention.
Intervention Type
Other
Intervention Name(s)
Education video
Intervention Description
six minute long education video focusing on protein and energy meals for older adults.
Primary Outcome Measure Information:
Title
Health related quality of life Using Rand 36 questionaire
Description
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
Time Frame
Change in Health related quality of life Using Rand 36 questionaire after 3 months
Secondary Outcome Measure Information:
Title
Body fat
Description
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
Time Frame
Change in Body mass index after 3 months.
Title
Readmissions to hospital after discharge from the hospital
Description
Readmissions after discharge from the hospital will be measured three months after discharge.
Time Frame
Registration of Readmissions 3 months after
Title
Muscle strength
Description
Measure Muscle Strength (in Kg) using Hydraulic Hand dynameter for Hand Grip strength in both hands.
Time Frame
Change in Hand Grip Strength (muscle strength) after 3 months
Title
The mid-arm circumferences
Description
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.
Time Frame
Change in the mid-arm cirumferences after three months.
Title
Subcutaneous fat
Description
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.
Time Frame
Change in Subcutaneous fat after three months.
Title
Muscle protein mass
Description
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)
Time Frame
Change in Muscle protein mass after 3 months
Title
Knowledge about nutrition
Description
Participants' knowledge about nutrition will be measured with a questionaire consisting of three questions related to the education video.
Time Frame
Registration in a questionaire three months after discharge from the hospital.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Persons given only a liquid diet.
Persons in a terminally ill phase.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Hansen, Master
Phone
0047 75517250
Email
monica.c.hansen@nord.no
Facility Information:
Facility Name
Monica Christin Hansen
City
Bodø
ZIP/Postal Code
8020
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Educational Intervention for Better Nutrition to Preserve Functionality - Design of a Randomised Clinical Trial
We'll reach out to this number within 24 hrs