Educational Intervention for Better Nutrition to Preserve Functionality - Design of a Randomised Clinical Trial

Malnutrition Clinical Trial

Official title:

Educational Intervention for Better Nutrition to Preserve Functionality - Design of a Randomised Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05950373
• Other study ID #: 366925
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: October 1, 2026

Study information

• Verified date: April 2024
• Source: Nord University
• Contact: Monica Hansen, Master
• Phone: 0047 75517250
• Email: monica.c.hansen[@]nord.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 276
• Est. completion date: October 1, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• Education video
six minute long education video focusing on protein and energy meals for older adults.

Locations

Country	Name	City	State
Norway	Monica Christin Hansen	Bodø

Sponsors (1)

Lead Sponsor	Collaborator
Nord University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Health related quality of life Using Rand 36 questionaire after 3 months
Secondary	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	Change in Body mass index after 3 months.
Secondary	Readmissions to hospital after discharge from the hospital	Readmissions after discharge from the hospital will be measured three months after discharge.	Registration of Readmissions 3 months after
Secondary	Muscle strength	Measure Muscle Strength (in Kg) using Hydraulic Hand dynameter for Hand Grip strength in both hands.	Change in Hand Grip Strength (muscle strength) after 3 months
Secondary	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.	Change in the mid-arm cirumferences after three months.
Secondary	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.	Change in Subcutaneous fat after three months.
Secondary	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)	Change in Muscle protein mass after 3 months
Secondary	Knowledge about nutrition	Participants' knowledge about nutrition will be measured with a questionaire consisting of three questions related to the education video.	Registration in a questionaire three months after discharge from the hospital.