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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malnutrition
• Intervention / Treatment: Other: Education video

• Study Type: Interventional
• Enrollment (Estimated): 276
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monica Hansen, Master; Phone Number: 0047 75517250; Email: monica.c.hansen@nord.no

Study Locations

• Norway
  • Bodø, Norway, 8020
    • Monica Christin Hansen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The control group will not be given any intervention.
Experimental: Intervention group; 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.	Other: Education video; six minute long education video focusing on protein and energy meals for older adults.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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.
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
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.
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
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.

Collaborators and Investigators

• Sponsor: Nord University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Older adults; Educational video; Diseases-related malnutrition
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 366925

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