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

Not Applicable

Not yet recruiting

• Conditions: Malnutrition

• Registration Number: NCT05950373
• Lead Sponsor: Nord University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-11
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Study Start: 2025-01-01
• Primary Completion: 2025-11-30
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 276

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Health related quality of life Using Rand 36 questionaire	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

Secondary Outcome Measures

Name	Time	Method
Muscle strength	Change in Hand Grip Strength (muscle strength) after 3 months	Measure Muscle Strength (in Kg) using Hydraulic Hand dynameter for Hand Grip strength in both hands.
Subcutaneous fat	Change in Subcutaneous fat after three months.	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.
Body fat	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/m2
Readmissions to hospital after discharge from the hospital	Registration of Readmissions 3 months after	Readmissions after discharge from the hospital will be measured three months after discharge.
The mid-arm circumferences	Change in the mid-arm cirumferences after three months.	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.
Knowledge about nutrition	Registration in a questionaire three months after discharge from the hospital.	Participants' knowledge about nutrition will be measured with a questionaire consisting of three questions related to the education video.
Muscle protein mass	Change in Muscle protein mass after 3 months	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)

Trial Locations

Locations (1)

Monica Christin Hansen; 🇳🇴 Bodø, Norway