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Developing and Testing Delicious and Nutritious for the Old People

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ClinicalTrials.gov Identifier: NCT03133364
Recruitment Status : Completed
First Posted : April 28, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Herlev and Gentofte Hospital
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

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.


Condition or disease Intervention/treatment Phase
Quality of Life Nutritional Deficiency Physical Performance Other: Sensory optimized meals Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Triple (Participant, Care Provider, Investigator)
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.

Primary Purpose: Prevention
Official Title: Developing and Testing Delicious and Nutritious for the Old People
Actual Study Start Date : May 17, 2017
Actual Primary Completion Date : August 8, 2017
Actual Study Completion Date : August 8, 2017

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.

Other: Sensory optimized meals
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.

Other: Sensory optimized meals
19 main meals and 12 between-meals are optimized and composed to a menu for 12 weeks.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.

  4. 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).

  5. 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.

  6. Weight [ Time Frame: 12 weeks ]
    The body weight of the participant is measured in the morning in the participants' home on a bathroom scale.

  7. Height [ Time Frame: 12 weeks ]
    Height will be measured with a folding ruler.

  8. EVS [ Time Frame: 12 weeks ]
    The Eating Validation Scheme (EVS) is a Danish nutritional assessment chart, used to assess nutritional intake and risk factors.

  9. 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.


  10. 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).

  11. 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:

    • 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133364


Locations
Denmark
Skovhuset, nursing home
Hillerod, Denmark, 3400
Sponsors and Collaborators
University of Copenhagen
Herlev and Gentofte Hospital
Investigators
Principal Investigator: Signe Loftager Okkels, Msc The Nutrition Research Unit, Gentofte University hospital.

Responsible Party: Arne Astrup, Head of institute (Nutrition Exercise and Sports), University of Copenhagen
ClinicalTrials.gov Identifier: NCT03133364     History of Changes
Other Study ID Numbers: H-17002835
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If other researchers are interested in the data, I am planning to share them after publication of the results.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders