- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03133364
Developing and Testing Delicious and Nutritious for the Old People
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hillerod, Denmark, 3400
- Skovhuset, nursing home
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sensory optimized meals
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. |
19 main meals and 12 between-meals are optimized and composed to a menu for 12 weeks.
|
Placebo Comparator: Control
Control group is receiving: Popular dishes selected from hospital and meal service menus, NOT optimized by sensory experts. |
19 main meals and 12 between-meals are optimized and composed to a menu for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health related quality of life (EQ-5D-3L)
Time Frame: 12 weeks
|
(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. |
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MMSE (mini mental status)
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Hand grip strenght
Time Frame: 12 weeks
|
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. |
12 weeks
|
Chair stand
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Diet registration
Time Frame: 4 days
|
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).
|
4 days
|
Satisfaction with food related life (SWFL)
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Weight
Time Frame: 12 weeks
|
The body weight of the participant is measured in the morning in the participants' home on a bathroom scale.
|
12 weeks
|
Height
Time Frame: 12 weeks
|
Height will be measured with a folding ruler.
|
12 weeks
|
EVS
Time Frame: 12 weeks
|
The Eating Validation Scheme (EVS) is a Danish nutritional assessment chart, used to assess nutritional intake and risk factors.
|
12 weeks
|
Liking
Time Frame: One month in the middle of the intervention
|
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. |
One month in the middle of the intervention
|
Compliance
Time Frame: 12 weeks
|
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).
|
12 weeks
|
Observations of meals
Time Frame: One month in the middle of the intervention
|
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:
|
One month in the middle of the intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Signe Loftager Okkels, Msc, The Nutrition Research Unit, Gentofte University hospital.
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-17002835
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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