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Developing and Testing Delicious and Nutritious for the Old People

Primary Purpose

Quality of Life, Nutritional Deficiency, Physical Performance

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Sensory optimized meals
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Quality of Life

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Skovhuset, nursing home

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sensory optimized meals

Control

Arm Description

Intervention group is receiving: Popular dishes selected from hospital and meal service menus optimized by sensory experts. Optimization is done with respect to taste, texture and appereance and on nutritional composition of the meals with focus on protein content.

Control group is receiving: Popular dishes selected from hospital and meal service menus, NOT optimized by sensory experts.

Outcomes

Primary Outcome Measures

Health related quality of life (EQ-5D-3L)
(EQ-5D-3L) is a standardized instrument for use as a measure of health outcome. The EQ-5D-3L descriptive system comprises the following 5 dimensions (5D): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels (3L): no problems (1 point), some problems (2 points), extreme problems (3 points). This gives a total of 245 different health states, adding unconscious and dead.

Secondary Outcome Measures

MMSE (mini mental status)
MMSE-test (mental function) MMSE is the most frequently used cognitive screening test, and has been developed with the aim of measuring cognitive abilities in the elderly and possibly changes in cognitive functioning over time.
Hand grip strenght
Hand Grip Strenght (HGS) is valid as a measure of mobility in both healthy people and patients and is associated with both physical (strenght of function) and mental (quality of life) aspects of the participant. HGS will be measured (in kg) with a Jamar 5030J1 Hydraulic Hand Dynanometer. It displays grip force up to 90 kg.
Chair stand
By means of the modified 30 seconds chair-stand. Participants are asked to fold their arms across their chest and to stand up and sit down on a chair, as many times as possible during 30 seconds. The seat should be a height of at least 43 cm. In the modified version the arm rests are used for assistance or safety.
Diet registration
In this study four days of diet registration will be done both in the intervention period and the control period on each participant to compare the energy and protein intake at the ordinary diet and at the project diet (intervention or control).
Satisfaction with food related life (SWFL)
SWFL consist of five items that can be measured independently, or grouped into a single dimension. The participants evaluate their degree of agreement, with five statements of answer possibilities (from disagree completely to agree completely), and a higher level means a better SWFL score.
Weight
The body weight of the participant is measured in the morning in the participants' home on a bathroom scale.
Height
Height will be measured with a folding ruler.
EVS
The Eating Validation Scheme (EVS) is a Danish nutritional assessment chart, used to assess nutritional intake and risk factors.
Liking
During an evening meal participants will evaluate sensory parameters of the side course and the main meal (appearance, taste and texture) with the counseling of a research assistant. A 5-point hedonic scale ranging from 1 (dislike very much) to 5 (like very much) with the medium response either like or dislike was chosen.
Compliance
A compliance sheet (compliance-week-schedule) of each week will be done to register how many times of the week the participant has eaten the project meals and how many times they have eaten something else from the ordinal menu (due to dislike of the ordinal menu or other reasons).
Observations of meals
In order to identify differences in the way the meal is handled and served an observational visit is done on the eight departments of the nursing home. The scheme includes six items: Preparation of the dinner, Tableware and serving, Presentation of the dinner, The food and side dishes, The ambiance during dinner, The role of the staff during dinner. Differences or coincidences from the observations will be found and used as background information to describe the meal situation.

Full Information

First Posted
April 25, 2017
Last Updated
January 19, 2018
Sponsor
University of Copenhagen
Collaborators
Herlev and Gentofte Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03133364
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 17, 2017 (Actual)
Primary Completion Date
August 8, 2017 (Actual)
Study Completion Date
August 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Herlev and Gentofte Hospital

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Nutritional Deficiency, Physical Performance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Participants are randomized to the control group (C) and intervention group (I) using the programme "Research randomizer". The main supervisor will manage the randomization. Participants are blinded to whether they receive the control or intervention menu. Each menu will daily consist of a main meal and a between-meal.
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sensory optimized meals
Arm Type
Active Comparator
Arm Description
Intervention group is receiving: Popular dishes selected from hospital and meal service menus optimized by sensory experts. Optimization is done with respect to taste, texture and appereance and on nutritional composition of the meals with focus on protein content.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control group is receiving: Popular dishes selected from hospital and meal service menus, NOT optimized by sensory experts.
Intervention Type
Other
Intervention Name(s)
Sensory optimized meals
Intervention Description
19 main meals and 12 between-meals are optimized and composed to a menu for 12 weeks.
Primary Outcome Measure Information:
Title
Health related quality of life (EQ-5D-3L)
Description
(EQ-5D-3L) is a standardized instrument for use as a measure of health outcome. The EQ-5D-3L descriptive system comprises the following 5 dimensions (5D): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels (3L): no problems (1 point), some problems (2 points), extreme problems (3 points). This gives a total of 245 different health states, adding unconscious and dead.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
MMSE (mini mental status)
Description
MMSE-test (mental function) MMSE is the most frequently used cognitive screening test, and has been developed with the aim of measuring cognitive abilities in the elderly and possibly changes in cognitive functioning over time.
Time Frame
12 weeks
Title
Hand grip strenght
Description
Hand Grip Strenght (HGS) is valid as a measure of mobility in both healthy people and patients and is associated with both physical (strenght of function) and mental (quality of life) aspects of the participant. HGS will be measured (in kg) with a Jamar 5030J1 Hydraulic Hand Dynanometer. It displays grip force up to 90 kg.
Time Frame
12 weeks
Title
Chair stand
Description
By means of the modified 30 seconds chair-stand. Participants are asked to fold their arms across their chest and to stand up and sit down on a chair, as many times as possible during 30 seconds. The seat should be a height of at least 43 cm. In the modified version the arm rests are used for assistance or safety.
Time Frame
12 weeks
Title
Diet registration
Description
In this study four days of diet registration will be done both in the intervention period and the control period on each participant to compare the energy and protein intake at the ordinary diet and at the project diet (intervention or control).
Time Frame
4 days
Title
Satisfaction with food related life (SWFL)
Description
SWFL consist of five items that can be measured independently, or grouped into a single dimension. The participants evaluate their degree of agreement, with five statements of answer possibilities (from disagree completely to agree completely), and a higher level means a better SWFL score.
Time Frame
12 weeks
Title
Weight
Description
The body weight of the participant is measured in the morning in the participants' home on a bathroom scale.
Time Frame
12 weeks
Title
Height
Description
Height will be measured with a folding ruler.
Time Frame
12 weeks
Title
EVS
Description
The Eating Validation Scheme (EVS) is a Danish nutritional assessment chart, used to assess nutritional intake and risk factors.
Time Frame
12 weeks
Title
Liking
Description
During an evening meal participants will evaluate sensory parameters of the side course and the main meal (appearance, taste and texture) with the counseling of a research assistant. A 5-point hedonic scale ranging from 1 (dislike very much) to 5 (like very much) with the medium response either like or dislike was chosen.
Time Frame
One month in the middle of the intervention
Title
Compliance
Description
A compliance sheet (compliance-week-schedule) of each week will be done to register how many times of the week the participant has eaten the project meals and how many times they have eaten something else from the ordinal menu (due to dislike of the ordinal menu or other reasons).
Time Frame
12 weeks
Title
Observations of meals
Description
In order to identify differences in the way the meal is handled and served an observational visit is done on the eight departments of the nursing home. The scheme includes six items: Preparation of the dinner, Tableware and serving, Presentation of the dinner, The food and side dishes, The ambiance during dinner, The role of the staff during dinner. Differences or coincidences from the observations will be found and used as background information to describe the meal situation.
Time Frame
One month in the middle of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Signe Loftager Okkels, Msc
Organizational Affiliation
The Nutrition Research Unit, Gentofte University hospital.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skovhuset, nursing home
City
Hillerod
ZIP/Postal Code
3400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
If other researchers are interested in the data, I am planning to share them after publication of the results.
Citations:
PubMed Identifier
34024505
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.
Results Reference
derived

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Developing and Testing Delicious and Nutritious for the Old People

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