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

Study Overview
=================
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.

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

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Other: Education video


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 110 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* six minute long education video focusing on protein and energy meals for older adults.<br>|
| No Intervention: Control group<br>The control group will not be 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 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 | 
| 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. | 
| 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 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Older adults, Diseases-related malnutrition, Educational video