search
Back to results

HOMEFOOD Study - Home Delivered Food and Nutrition Therapy for Discharged Geriatric Hospital Patients (HOMEFOOD)

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Iceland
Study Type
Interventional
Intervention
NCP and home-delivered meals
Sponsored by
University of Iceland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Malnutrition, Old adults, Home-delivered meals, NCP - Nutrition Care Process, Food

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Geriatric Unit of Landspitali - University Hospital of Iceland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

NCP and home-delivered meals

Current practice

Arm Description

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

Current practice after discharge from the University Hospital of Iceland.

Outcomes

Primary Outcome Measures

Body weight
Body weight in kilograms
Body weight
Body weight in kilograms
Body weight
Body weight in kilograms
Five Times Sit to Stand Test
Part of short physical performance battery, yes vs no
Five Times Sit to Stand Test
Part of short physical performance battery, yes vs no
Five Times Sit to Stand Test
Part of short physical performance battery, yes vs no
Balance test
Part of short physical performance battery, yes vs no
Balance test
Part of short physical performance battery, yes vs no
Balance test
Part of short physical performance battery, yes vs no
Energy intake
Energy in kilocalories per 24 hours
Energy intake
Energy in kilocalories per 24 hours
Energy intake
Energy in kilocalories per 24 hours
Protein intake
Protein intake in g/day
Protein intake
Protein intake in g/day
Protein intake
Protein intake in g/day
Fluid intake
Fluid intake evaluated
Fluid intake
Fluid intake evaluated
Fluid intake
Fluid intake evaluated
Upper arm circumference
Measured in centimeters
Upper arm circumference
Measured in centimeters
Waist circumference
Measured in centimeters
Waist circumference
Measured in centimeters
calf circumference
Measured in centimeters
calf circumference
Measured in centimeters
lean body mass
Measured with BIA (kg)
lean body mass
Measured with BIA (kg)
Grip strength
Measured in kg
Grip strength
Measured in kg
Grip strength
Measured in lbs
Health Related Quality of Life (HRQL)
EQ-5D including SRH
Health Related Quality of Life (HRQL)
EQ-5D including SRH
Health Related Quality of Life (HRQL)
EQ-5D including SRH
Depression
Center for Epidemiologic Studies Depression scale
Depression
Center for Epidemiologic Studies Depression scale
Cognitive function
MMSE
Cognitive function
MMSE
Nutrition status
Icelandic Nutrition Screening Tool (score)
Nutrition status
Icelandic Nutrition Screening Tool (score)

Secondary Outcome Measures

Re-hospitalization
Number of participants who were re-hospitalized
Mortality
Number of participants who deceased

Full Information

First Posted
January 9, 2019
Last Updated
November 16, 2021
Sponsor
University of Iceland
search

1. Study Identification

Unique Protocol Identification Number
NCT03995303
Brief Title
HOMEFOOD Study - Home Delivered Food and Nutrition Therapy for Discharged Geriatric Hospital Patients
Acronym
HOMEFOOD
Official Title
HOMEFOOD Study - Home Delivered Food and Nutrition Therapy for Discharged Geriatric Hospital Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
August 26, 2020 (Actual)
Study Completion Date
August 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iceland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Malnutrition is common in older people admitted to the hospital and can worsen after discharge. Therefore, it seems necessary to integrate nutritional support not only during the hospital stay but also in the period after discharge. The aim of this Randomized Controlled Trial (RCT) is to test whether nutritional support provided by a dietitian, using Nutrition Care Process in combination with delivered meals designed for the needs of older adults (group 1), improves nutritional status, muscle strength, physical function, quality of life and as a secondary outcome re-hospitalization and/or mortality of geriatric patients with malnutrition risk after discharge compared to currently used standard care (group 2 = control). Time and work plan: After 12 months Need identification and product ideas ready Packaging material ready Estimate of the feasibility of meals for old adults Allowances from the ethical committee, the data protection committee, the Ph.D. committee of the Faculty of Food Science and Nutrition at the University of Iceland. After 24 months The last participant recruited End of intervention After 36 months End of follow up Database ready First paper submitted Methods-Intervention This 24-week randomized controlled trial will randomize the participants (N = 200) to two groups. The dietitian (Ph.D. student) will perform a total of 5 home visits during the study period to participants in the intervention group. Meals will be delivered weekly to the participants. Outcome parameters will be measured just before discharge from the hospital and after 12 weeks and at 24 weeks in the home of the participants. Data on hospital re-admission and mortality will also be followed up at 12 months. The aim of the intervention is to implement individual dietetic advice and optimize participants' nutritional status by following the Nutritional Care Process*, involving nutritional assessment, diagnosis, intervention, monitoring, and evaluation. Dietary counseling, motivation, and education will help to maintain participants' body weight, and ensure that energy and protein requirements as well as for other critical nutrients are achieved. *The Nutrition Care Process (NCP) reflects the current state of the art in nutrition care and is designed to improve the consistency and quality of individualized care for patients and the predictability of the patient outcomes. It is not intended to standardize nutrition care for each patient, but to establish a standardized process for providing care. To achieve the aim, the dietitian (Ph.D. student) will meet the participants in the intervention group, six times. The day before discharge where baseline measurements will be done, 1 week after discharge, 3 weeks after discharge, 6 weeks after discharge, 9 weeks after discharge, and 12 weeks after discharge where endpoint measurements will be done. 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. To assess dietary intake, the dietitian will perform a dietary history interview at each visit to determine fluid, energy and protein intake of the participant. Strategies for achieving fluid, energy and protein requirements and achieving compliance included dietary counseling with attention to nutritional risk factors, timing, size and frequency of meals, recommendations for nutrient dense foods and drinks, and provision of educational material. If relevant, the dietitian will: initiate the prescription of oral nutritional supplements with high energy and protein density that will be reimbursed by Health Insurance. Contact providers of meals-on-wheels to change the meals to high energy and protein dense menu or to mashed/puréed food. Recommend use of vitamin D, calcium and other vitamins-minerals considered necessary to achieve optimal nutritional status, Invite home care and community nursing staff to participate in home visits to achieve the best possible outcome for the patient by interdisciplinary collaboration. If considered relevant the participants will receive a short consultation by telephone by the dietitian to give advice and to stimulate compliance to the proposed nutritional care plan in-between the home visits. The control group will meet the dietitian/staff for baseline, 12 weeks and at the 24-week endpoint measurements. The control group will not receive any dietary counseling or education during the study period which reflects current clinical practice. The Ph.D. students' contributions A Ph.D. student in clinical nutrition (Berglind Soffía Blondal) will be the project manager of the intervention study on a day-to-day base. The student will be supervised by Prof. Alfons Ramel and Assoc. Prof. Ólöf Guðný Geirsdóttir, both on the Faculty of Food Science and Nutrition. The student will be involved in application work to the ethical committee, screening, conduct of the intervention study, data work and writing of scientific papers. Ethics The study has been approved by the Ethics Committee of Landspitali- University Hospital of Iceland and informed written consent will be obtained from all participants. The study can only improve the nutritional status of geriatric patients that take part in the intervention groups. The participants in the control group, however, won't get any nutritional interventions and therefore have a greater risk of re-admissions and a worse overall outcome compared to the intervention groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Malnutrition, Old adults, Home-delivered meals, NCP - Nutrition Care Process, Food

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NCP and home-delivered meals
Arm Type
Active Comparator
Arm Description
Preventing malnutrition with NCP by a registered dietician and home-delivered meals
Arm Title
Current practice
Arm Type
No Intervention
Arm Description
Current practice after discharge from the University Hospital of Iceland.
Intervention Type
Other
Intervention Name(s)
NCP and home-delivered meals
Other Intervention Name(s)
NCP and delivered meals
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body weight
Description
Body weight in kilograms
Time Frame
Measurement at discharge, baseline
Title
Body weight
Description
Body weight in kilograms
Time Frame
Measurement at 12 weeks
Title
Body weight
Description
Body weight in kilograms
Time Frame
Measurement at 24 weeks
Title
Five Times Sit to Stand Test
Description
Part of short physical performance battery, yes vs no
Time Frame
Measurement at discharge, baseline
Title
Five Times Sit to Stand Test
Description
Part of short physical performance battery, yes vs no
Time Frame
Measurement at 12 weeks
Title
Five Times Sit to Stand Test
Description
Part of short physical performance battery, yes vs no
Time Frame
Measurement at 24 weeks
Title
Balance test
Description
Part of short physical performance battery, yes vs no
Time Frame
Measurement at discharge, baseline
Title
Balance test
Description
Part of short physical performance battery, yes vs no
Time Frame
Measurement at 12 weeks
Title
Balance test
Description
Part of short physical performance battery, yes vs no
Time Frame
Measurement at 24 weeks
Title
Energy intake
Description
Energy in kilocalories per 24 hours
Time Frame
Measurement at discharge, baseline
Title
Energy intake
Description
Energy in kilocalories per 24 hours
Time Frame
Measurement at 12 weeks
Title
Energy intake
Description
Energy in kilocalories per 24 hours
Time Frame
Measurement at 24 weeks
Title
Protein intake
Description
Protein intake in g/day
Time Frame
Measurement at 12 weeks
Title
Protein intake
Description
Protein intake in g/day
Time Frame
Measurement at discharge, baseline
Title
Protein intake
Description
Protein intake in g/day
Time Frame
Measurement at 24 weeks
Title
Fluid intake
Description
Fluid intake evaluated
Time Frame
Measurement at discharge, baseline
Title
Fluid intake
Description
Fluid intake evaluated
Time Frame
Measurement at 12 weeks
Title
Fluid intake
Description
Fluid intake evaluated
Time Frame
Measurement at 24 weeks
Title
Upper arm circumference
Description
Measured in centimeters
Time Frame
Measurement at discharge, baseline
Title
Upper arm circumference
Description
Measured in centimeters
Time Frame
Measurement at 24 weeks
Title
Waist circumference
Description
Measured in centimeters
Time Frame
Measurement at discharge, baseline
Title
Waist circumference
Description
Measured in centimeters
Time Frame
Measurement at 24 weeks
Title
calf circumference
Description
Measured in centimeters
Time Frame
Measurement at discharge, baseline
Title
calf circumference
Description
Measured in centimeters
Time Frame
Measurement at 24 weeks
Title
lean body mass
Description
Measured with BIA (kg)
Time Frame
Measurement at discharge, baseline
Title
lean body mass
Description
Measured with BIA (kg)
Time Frame
Measurement at 24 weeks
Title
Grip strength
Description
Measured in kg
Time Frame
Measurement at discharge, baseline
Title
Grip strength
Description
Measured in kg
Time Frame
Measurement at 12 weeks
Title
Grip strength
Description
Measured in lbs
Time Frame
Measurement at 24 weeks
Title
Health Related Quality of Life (HRQL)
Description
EQ-5D including SRH
Time Frame
Measurement at discharge, baseline
Title
Health Related Quality of Life (HRQL)
Description
EQ-5D including SRH
Time Frame
Measurement at 12 weeks
Title
Health Related Quality of Life (HRQL)
Description
EQ-5D including SRH
Time Frame
Measurement at 24 weeks
Title
Depression
Description
Center for Epidemiologic Studies Depression scale
Time Frame
Measurement at discharge, baseline
Title
Depression
Description
Center for Epidemiologic Studies Depression scale
Time Frame
Measurement at 24 weeks
Title
Cognitive function
Description
MMSE
Time Frame
Measurement at discharge, baseline
Title
Cognitive function
Description
MMSE
Time Frame
Measurement at 24 weeks
Title
Nutrition status
Description
Icelandic Nutrition Screening Tool (score)
Time Frame
Measurement at discharge, baseline.
Title
Nutrition status
Description
Icelandic Nutrition Screening Tool (score)
Time Frame
Measurement at 24 weeks
Secondary Outcome Measure Information:
Title
Re-hospitalization
Description
Number of participants who were re-hospitalized
Time Frame
at 12 months from recruitment to trial
Title
Mortality
Description
Number of participants who deceased
Time Frame
at 12 months from recruitment to trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Living at a nursing home MMSE score of under 20 No nutritional risk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfons Ramel, Ph.D.
Organizational Affiliation
University of Iceland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olof G Geirsdottir, Ph.D.
Organizational Affiliation
University of Iceland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Berglind S Blondal, MSc
Organizational Affiliation
University of Iceland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geriatric Unit of Landspitali - University Hospital of Iceland
City
Reykjavík
State/Province
Non-US
ZIP/Postal Code
101
Country
Iceland

12. IPD Sharing Statement

Citations:
PubMed Identifier
36028775
Citation
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.
Results Reference
derived

Learn more about this trial

HOMEFOOD Study - Home Delivered Food and Nutrition Therapy for Discharged Geriatric Hospital Patients

We'll reach out to this number within 24 hrs