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Preventing Malnutrition Among Older Adults

Primary Purpose

Malnutrition

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Education video
Sponsored by
Nord University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition focused on measuring older adults, Disease-related malnutrition, Educational video

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Orthopedic and surgical in bedded patient patients in a selected regional hospital in Norway. Over 65 years old. Have their home address in one of nine selected municipalities in Nordland county. home living and due to return home after discharge directly from the hospital or after a short-term training stay at a training centre before returning home. Could read and understand Norwegian. Have consent competence. Have a Body mass index less than 24. Exclusion Criteria: Patients patients only receiving liquid diet such as tube feeding terminal-ill patients

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

will get access to a six-minute educational video five days after being discharged from the hospital. The video is focusing on protein and energy meals for older adults.

Control group, not given any intervention

Outcomes

Primary Outcome Measures

Health related quality of life Using Rand 36 Questionnaire
Using Rand 36 Questionnaire

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/m^2.
Readmissions to hospital after discharge from the hospital
Readmissions after discharge from the hospital will be meassured three months after discharge
Muscle Strength
Measure Muscle Strength in kg using Saehan Hydraulic Hand Dynometer for Hand Grip strength in both hands.
The mid-arm circumference
The mid-arm circumference (MAC) will be measured in cm with a measuring tape. This will be done of the left upper arm measured at the midpoint between the tip 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 by a 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 circumference (MAMC) calculated according to the formula: MAMC (cm) = MAC (cm) - (3,14 X TFS x 0,1)

Full Information

First Posted
April 17, 2023
Last Updated
June 20, 2023
Sponsor
Nord University
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1. Study Identification

Unique Protocol Identification Number
NCT05860140
Brief Title
Preventing Malnutrition Among Older Adults
Official Title
Prevention and Treatment of Malnutrition Among Home-living Older Adults Over 65 Years.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
January 20, 2026 (Anticipated)
Study Completion Date
June 6, 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 aims to explore 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, Disease-related malnutrition, Educational video

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
will get access to a six-minute educational video five days after being discharged from the hospital. The video is focusing on protein and energy meals for older adults.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group, not given any intervention
Intervention Type
Other
Intervention Name(s)
Education video
Intervention Description
Six minutes long education video focusing on protein and energy meals
Primary Outcome Measure Information:
Title
Health related quality of life Using Rand 36 Questionnaire
Description
Using Rand 36 Questionnaire
Time Frame
Change in Health related quality of life Using Rand 36 Questionnaire 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/m^2.
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 meassured three months after discharge
Time Frame
Registration of Readmissions 3 months after
Title
Muscle Strength
Description
Measure Muscle Strength in kg using Saehan Hydraulic Hand Dynometer for Hand Grip strength in both hands.
Time Frame
Change in Hand Grip Strength (muscle strenght) after 3 months
Title
The mid-arm circumference
Description
The mid-arm circumference (MAC) will be measured in cm with a measuring tape. This will be done of the left upper arm measured at the midpoint between the tip of the shoulder and the tip of the elbow
Time Frame
Change in The mid-arm circumference after 3 months
Title
Subcutaneous fat
Description
Subcutaneous fat will be measured by Triceps skinfold thickness (TFS). This will be done by a in millimetres with a VirtuFits Digital Fat Caliper skinfold in the triceps of the left arm.
Time Frame
Change in Subcutaneous fat after 3 months
Title
Muscle protein mass
Description
Muscle protein mass will be measured by the mean arm muscle circumference (MAMC) calculated according to the formula: MAMC (cm) = MAC (cm) - (3,14 X TFS x 0,1)
Time Frame
Change in Muscle protein mass after 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Orthopedic and surgical in bedded patient patients in a selected regional hospital in Norway. Over 65 years old. Have their home address in one of nine selected municipalities in Nordland county. home living and due to return home after discharge directly from the hospital or after a short-term training stay at a training centre before returning home. Could read and understand Norwegian. Have consent competence. Have a Body mass index less than 24. Exclusion Criteria: Patients patients only receiving liquid diet such as tube feeding terminal-ill patients
Facility Information:
Facility Name
Monica Christin Hansen
City
Bodø
ZIP/Postal Code
8020
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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Preventing Malnutrition Among Older Adults

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