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

No phase Interventional Malnutrition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Education video.
Who it may be relevant to
Registry conditions: Malnutrition. Basic parameters: 65 years — 110 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Health related quality of life Using Rand 36 questionaire [Time frame: Change in Health related quality of life Using Rand 36 questionaire after 3 months]
Secondary outcome measures (7)
  • Body fat [Time frame: Change in Body mass index after 3 months.]
  • Readmissions to hospital after discharge from the hospital [Time frame: Registration of Readmissions 3 months after]
  • Muscle strength [Time frame: Change in Hand Grip Strength (muscle strength) after 3 months]
  • The mid-arm circumferences [Time frame: Change in the mid-arm cirumferences after three months.]
  • Subcutaneous fat [Time frame: Change in Subcutaneous fat after three months.]
  • Muscle protein mass [Time frame: Change in Muscle protein mass after 3 months]
  • Knowledge about nutrition [Time frame: Registration in a questionaire three months after discharge from the hospital.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Norway · 1 center
  • Monica Christin Hansen — Bodø

Publications

  • Hansen MC, Uhrenfeldt L, Ingstad K, Pedersen PU. Educational nutritional intervention to prevent loss of health-related quality of life among older adults after a surgical treatment: design of a randomised controlled trial. Trials. 2024 Apr 15;25(1):262. doi: 10.1186/s13063-024-08096-8. PMID 38622729

Identifiers

NCT: NCT05950373 · 366925

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗