Clinical trial NCT03133364: Developing and Testing Delicious and Nutritious for the Old People
Official title: Developing and Testing Delicious and Nutritious for the Old People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Nutritional Deficiency
Physical Performance
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Herlev and Gentofte Hospital
First posted: 2017-04-28
Enrollment: 52
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-armed randomized controlled study which in total runs 12 weeks.

It has been calculated that 106 participants should be completed. With the risk of loss, 150 elderly are screened and invited to join the study, whereas 120 elderly should be included.

Fifty participants are randomized to receive a control menu for 12 weeks and fifty participants are randomized to receive an intervention menu for 12 weeks.

To enhance subject compliance and avoid treatment group contamination the randomization will be done in "blocks" where each of the 8 departments of the nursing home is randomized to either the Control or Intervention group.
Primary purpose: PREVENTION

Brief summary: Meals-on wheels may play a major role in contributing to better nourishment and quality of life in older people, thus delaying costly hospitalisation. Still, dwelling, old adults who receive meals-on-wheels are a population at risk of undernutrition leading to a decreased quality of life.

Hypothesis Offering nutritious ELDORADO meals as meals-on-wheels to nursing home residents in 3 months is an effective way to increase quality of life.

Aim To improve quality of life and functional abilities in nursing home residents by offering nutritious ELDORADO meals.

Detailed description: Intervention The intervention group (n=50) will receive an optimized menu (in both sensory and nutritious aspects) for 12 weeks. In cooperation with the Copenhagen house of food and sensory staff, 19 main meals and 12 between-meals have been optimized based on nursing home residents' evaluations of sensory aspects. On a daily basis the menu will consist of 1 optimized main meal and 1 optimized between-meal, served for dinner. There will be no selective choice for the elderly. If a participant does not want the daily meal, he will receive another meal from the ordinary menu from the kitchen.

Control In comparison, the control group (n=50) will receive the same menu as the intervention group, however, the meals are not optimized on sensory and nutritious aspects. On a daily basis this menu also includes 1 main meal and 1 between-meal in 12 weeks. If a participant does not want the daily meal, he will receive another meal from the ordinary menu from the kitchen.

Eligibility criteria: Inclusion Criteria:

* Living at Skovhuset, nursing home in Hillerød municipality, Denmark.
* Collecting the "energy-dense diet" "ældrekost" with 40 % fat, with a main meal and a dessert/starter.
* Able to understand and follow instructions for the procedures of the study.
* Above 65 years.

Exclusion Criteria:

* Have chewing or swallowing difficulties.
* Have acute disease or acute change in chronic disease.
* Living after special nutritional standards e.g. vegetarian, have any food allergies, or if a participant is excluding common foods from their diet because of other reasons.
* Not able or willing to give informed consent.

Primary outcomes:
measure: Health related quality of life (EQ-5D-3L)
timeFrame: 12 weeks
Secondary outcomes:
measure: MMSE (mini mental status)
timeFrame: 12 weeks
measure: Hand grip strenght
timeFrame: 12 weeks
measure: Chair stand
timeFrame: 12 weeks
measure: Diet registration
timeFrame: 4 days
measure: Satisfaction with food related life (SWFL)
timeFrame: 12 weeks
measure: Weight
timeFrame: 12 weeks
measure: Height
timeFrame: 12 weeks
measure: EVS
timeFrame: 12 weeks
measure: Liking
timeFrame: One month in the middle of the intervention
measure: Compliance
timeFrame: 12 weeks
measure: Observations of meals
timeFrame: One month in the middle of the intervention
Other outcomes:
Locations:
city: Hillerod
country: Denmark
facility: Skovhuset, nursing home
Study officials:
affiliation: The Nutrition Research Unit, Gentofte University hospital.
name: Signe Loftager Okkels, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Okkels SL, Dybdal DR, Pedersen RJ, Klausen TW, Olsen A, Beck AM, Bugel S. A culinary twist of a two-course meals-on-wheels menu in a cluster-randomized controlled trial influencing health-related quality of life in nursing home residents. Clin Nutr ESPEN. 2021 Jun;43:137-147. doi: 10.1016/j.clnesp.2021.02.002. Epub 2021 Mar 2.