Developing and Testing Delicious and Nutritious for the Old People

NCT03133364 | Completed

• 1 other identifier: H-17002835
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Nutritional Deficiency; Physical Performance

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (11)

• MMSE (mini mental status)

  12 weeks

• Hand grip strenght

  12 weeks

• Chair stand

  12 weeks

• Diet registration

  4 days

• Satisfaction with food related life (SWFL)

  12 weeks

Study Arms (2)

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.

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.

Other: Sensory optimized meals

Interventions

Sensory optimized meals OTHER

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

Control; Sensory optimized meals

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Copenhagen: lead
• Herlev and Gentofte Hospital: collaborator

Study Sites (1)

Skovhuset, nursing home

Hillerød, 3400, Denmark

Location

Related Publications (1)

• 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.

  PMID: 34024505 DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Signe Loftager Okkels, Msc

  The Nutrition Research Unit, Gentofte University hospital.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of institute (Nutrition Exercise and Sports)

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: April 28, 2017
• Study Start: May 17, 2017
• Primary Completion: August 8, 2017
• Study Completion: August 8, 2017
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

DK (1)