NCT03995303

Brief Summary

Because of short hospital stays, and nutritional status worsening for geriatric patients, time to improve this is limited. It seems necessary to integrate nutritional support after discharge, to prevent the consequences of malnutrition on health and physical capability. This study tests whether nutrition support using NCP (Nutrition Care Process) (1) in combination with delivered meals designed for old adults, improves nutritional status, muscle strength, physical function, quality of life and rehospitalization and mortality rates after discharge, compared to currently used care (2 = control) along with historical data. Participants (N = 200), will be randomized into two groups, the intervention will last 24 weeks. A dietitian (Ph.D. student) visits participants in the intervention group 5 times during the study period. Outcome parameters will be measured before discharge from the hospital, at 12 weeks and at 24 weeks. Data on hospital readmission and mortality will be followed up at 6 months after the intervention. Condition or disease: Malnutrition Intervention/treatment: NCP by a dietitian and free food constructed to fulfill protein and energy needs for the group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2020

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

1.7 years

First QC Date

January 9, 2019

Last Update Submit

November 16, 2021

Conditions

Malnutrition

Keywords

MalnutritionOld adultsHome-delivered mealsNCP - Nutrition Care ProcessFood

Outcome Measures

Primary Outcomes (38)

  • Body weight

    Body weight in kilograms

    Measurement at discharge, baseline

  • Body weight

    Body weight in kilograms

    Measurement at 12 weeks

  • Body weight

    Body weight in kilograms

    Measurement at 24 weeks

  • Five Times Sit to Stand Test

    Part of short physical performance battery, yes vs no

    Measurement at discharge, baseline

  • Five Times Sit to Stand Test

    Part of short physical performance battery, yes vs no

    Measurement at 12 weeks

  • Five Times Sit to Stand Test

    Part of short physical performance battery, yes vs no

    Measurement at 24 weeks

  • Balance test

    Part of short physical performance battery, yes vs no

    Measurement at discharge, baseline

  • Balance test

    Part of short physical performance battery, yes vs no

    Measurement at 12 weeks

  • Balance test

    Part of short physical performance battery, yes vs no

    Measurement at 24 weeks

  • Energy intake

    Energy in kilocalories per 24 hours

    Measurement at discharge, baseline

  • Energy intake

    Energy in kilocalories per 24 hours

    Measurement at 12 weeks

  • Energy intake

    Energy in kilocalories per 24 hours

    Measurement at 24 weeks

  • Protein intake

    Protein intake in g/day

    Measurement at 12 weeks

  • Protein intake

    Protein intake in g/day

    Measurement at discharge, baseline

  • Protein intake

    Protein intake in g/day

    Measurement at 24 weeks

  • Fluid intake

    Fluid intake evaluated

    Measurement at discharge, baseline

  • Fluid intake

    Fluid intake evaluated

    Measurement at 12 weeks

  • Fluid intake

    Fluid intake evaluated

    Measurement at 24 weeks

  • Upper arm circumference

    Measured in centimeters

    Measurement at discharge, baseline

  • Upper arm circumference

    Measured in centimeters

    Measurement at 24 weeks

  • Waist circumference

    Measured in centimeters

    Measurement at discharge, baseline

  • Waist circumference

    Measured in centimeters

    Measurement at 24 weeks

  • calf circumference

    Measured in centimeters

    Measurement at discharge, baseline

  • calf circumference

    Measured in centimeters

    Measurement at 24 weeks

  • lean body mass

    Measured with BIA (kg)

    Measurement at discharge, baseline

  • lean body mass

    Measured with BIA (kg)

    Measurement at 24 weeks

  • Grip strength

    Measured in kg

    Measurement at discharge, baseline

  • Grip strength

    Measured in kg

    Measurement at 12 weeks

  • Grip strength

    Measured in lbs

    Measurement at 24 weeks

  • Health Related Quality of Life (HRQL)

    EQ-5D including SRH

    Measurement at discharge, baseline

  • Health Related Quality of Life (HRQL)

    EQ-5D including SRH

    Measurement at 12 weeks

  • Health Related Quality of Life (HRQL)

    EQ-5D including SRH

    Measurement at 24 weeks

  • Depression

    Center for Epidemiologic Studies Depression scale

    Measurement at discharge, baseline

  • Depression

    Center for Epidemiologic Studies Depression scale

    Measurement at 24 weeks

  • Cognitive function

    MMSE

    Measurement at discharge, baseline

  • Cognitive function

    MMSE

    Measurement at 24 weeks

  • Nutrition status

    Icelandic Nutrition Screening Tool (score)

    Measurement at discharge, baseline.

  • Nutrition status

    Icelandic Nutrition Screening Tool (score)

    Measurement at 24 weeks

Secondary Outcomes (2)

  • Re-hospitalization

    at 12 months from recruitment to trial

  • Mortality

    at 12 months from recruitment to trial

Study Arms (2)

NCP and home-delivered meals

ACTIVE COMPARATOR

Preventing malnutrition with NCP by a registered dietician and home-delivered meals

Other: NCP and home-delivered meals

Current practice

NO INTERVENTION

Current practice after discharge from the University Hospital of Iceland.

Interventions

NCP and home-delivered mealsOTHER

The dietitian (Ph.D. student) will perform an individual nutritional assessment focusing on dietary intake, activity level and weight of each participant, as a basis for developing an individualized nutrition care plan consistent with estimated nutritional requirements and nutritional rehabilitation goals. Total fluid, energy- and protein requirements will be estimated for each patient. Giving the group free food to fulfill protein-and energy needs.

Also known as: NCP and delivered meals
NCP and home-delivered meals

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients of the geriatric units at the University Hospital of Iceland discharging home to independent living
  • A score of 20 or above on the Mini-Mental State Evaluation (MMSE) form
  • Being at nutritional risk according to the validated nutritional risk screening tool (NRS-2002, score 3+)
  • The capability of eating orally

You may not qualify if:

  • Living at a nursing home
  • MMSE score of under 20
  • No nutritional risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric Unit of Landspitali - University Hospital of Iceland

Reykjavik, Non-US, 101, Iceland

Location

Related Publications (2)

  • Eymundsdottir H, Blondal BS, Geirsdottir OG, Ramel A. Poor Activities of Daily Living Predict Future Weight Loss in Older Adults After Hospital Discharge-Secondary Analysis of a Randomized Trial. J Aging Phys Act. 2024 Aug 16;33(1):42-50. doi: 10.1123/japa.2023-0104. Print 2025 Feb 1.

    PMID: 39151910DERIVED

  • Blondal BS, Geirsdottir OG, Beck AM, Halldorsson TI, Jonsson PV, Sveinsdottir K, Ramel A. HOMEFOOD randomized trial-beneficial effects of 6-month nutrition therapy on body weight and physical function in older adults at risk for malnutrition after hospital discharge. Eur J Clin Nutr. 2023 Jan;77(1):45-54. doi: 10.1038/s41430-022-01195-2. Epub 2022 Aug 26.

    PMID: 36028775DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Alfons Ramel, Ph.D.

    University of Iceland

    PRINCIPAL INVESTIGATOR

  • Olof G Geirsdottir, Ph.D.

    University of Iceland

    PRINCIPAL INVESTIGATOR

  • Berglind S Blondal, MSc

    University of Iceland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 9, 2019

First Posted

June 24, 2019

Study Start

January 1, 2019

Primary Completion

August 26, 2020

Study Completion

August 26, 2020

Last Updated

November 17, 2021

Record last verified: 2021-11

Locations

IC(1)