Quality of LifeNCT03133364
Developing and Testing Delicious and Nutritious for the Old People
A study testing Sensory optimized meals in people with Quality of Life and Nutritional Deficiency, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Nutritional Deficiency, Physical Performance
- What is being tested?
- Sensory optimized meals
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- 17 May 2017to 8 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Sensory optimized meals
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory optimized mealsOther
19 main meals and 12 between-meals are optimized and composed to a menu for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sensory optimized meals | Active comparator | 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. Receives: Other: Sensory optimized meals |
| Control | Placebo comparator | Control group is receiving:
Popular dishes selected from hospital and meal service menus, NOT optimized by sensory experts. Receives: Other: Sensory optimized meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (11)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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).
Measured: 4 days
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.
Measured: 12 weeks
Weight
The body weight of the participant is measured in the morning in the participants' home on a bathroom scale.
Measured: 12 weeks
Height
Height will be measured with a folding ruler.
Measured: 12 weeks
EVS
The Eating Validation Scheme (EVS) is a Danish nutritional assessment chart, used to assess nutritional intake and risk factors.
Measured: 12 weeks
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.
Measured: One month in the middle of the intervention
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).
Measured: 12 weeks
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.
Measured: One month in the middle of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start17 May 2017
- Primary completion8 Aug 2017
- Study completion8 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev and Gentofte Hospital
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Signe Loftager Okkels, Msc, Principal investigator, The Nutrition Research Unit, Gentofte University hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133364
- Sponsor's protocol ID
- H-17002835
- Status last verified
- Jan 2018
- First submitted
- 25 Apr 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If other researchers are interested in the data, I am planning to share them after publication of the results.
Publications
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.
PubMed 34024505
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing Delicious and Nutritious for the Old People
- ClinicalTrials.gov ID
- NCT03133364
- Acronym / sponsor ID
- H-17002835
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Herlev and Gentofte Hospital
- Study start
- 17 May 2017 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 8 Aug 2017 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sensory optimized meals | Active comparator | Other: Sensory optimized mealsIntervention 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 | Placebo comparator | Other: Sensory optimized mealsControl group is receiving: Popular dishes selected from hospital and meal service menus, NOT optimized by sensory experts. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory optimized meals19 main meals and 12 between-meals are optimized and composed to a menu for 12 weeks. | Other | Control, Sensory optimized meals |
Primary outcome
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.
11 secondary outcomes
MMSE (mini mental status)
Time frame: 12 weeks
Hand grip strenght
Time frame: 12 weeks
Chair stand
Time frame: 12 weeks
Diet registration
Time frame: 4 days
Satisfaction with food related life (SWFL)
Time frame: 12 weeks
Weight
Time frame: 12 weeks
Height
Time frame: 12 weeks
EVS
Time frame: 12 weeks
Liking
Time frame: One month in the middle of the intervention
Compliance
Time frame: 12 weeks
Observations of meals
Time frame: One month in the middle of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Derived from this study: PubMed 34024505Okkels 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.
- Homepage for the projectLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. If other researchers are interested in the data, I am planning to share them after publication of the results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Signe Loftager Okkels, Msc principal investigator
The Nutrition Research Unit, Gentofte University hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory optimized meals in people with Quality of Life and Nutritional Deficiency, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (EQ-5D-3L) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03133364, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.