MalnutritionHOMEFOODNCT03995303
HOMEFOOD Study - Home Delivered Food and Nutrition Therapy for Discharged Geriatric Hospital Patients
A study testing NCP and home-delivered meals in people with Malnutrition, run by University of Iceland at 1 site in Iceland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- NCP and home-delivered meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteIceland
- Study dates
- 1 Jan 2019to 26 Aug 2020
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Living at a nursing home
- MMSE score of under 20
- No nutritional risk
Trial locations and contacts
1 site in 1 country.
Iceland1 site
Geriatric Unit of Landspitali - University Hospital of Iceland
Reykjavik, Non-US, 101
About this study
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.
Read the 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.
- Conditions
- Malnutrition
- Being tested
- NCP and home-delivered meals
- Keywords
- Malnutrition, Old adults, Home-delivered meals, NCP - Nutrition Care Process, Food
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCP and home-delivered mealsOther
Also called NCP and delivered meals
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.
| Study group | Role | What they receive |
|---|---|---|
| NCP and home-delivered meals | Active comparator | Preventing malnutrition with NCP by a registered dietician and home-delivered meals Receives: Other: NCP and home-delivered meals |
| Current practice | No intervention | Current practice after discharge from the University Hospital of Iceland. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight in kilograms
Measured: Measurement at discharge, baseline
Body weight
Body weight in kilograms
Measured: Measurement at 12 weeks
Body weight
Body weight in kilograms
Measured: Measurement at 24 weeks
Five Times Sit to Stand Test
Part of short physical performance battery, yes vs no
Measured: Measurement at discharge, baseline
Five Times Sit to Stand Test
Part of short physical performance battery, yes vs no
Measured: Measurement at 12 weeks
Five Times Sit to Stand Test
Part of short physical performance battery, yes vs no
Measured: Measurement at 24 weeks
Balance test
Part of short physical performance battery, yes vs no
Measured: Measurement at discharge, baseline
Balance test
Part of short physical performance battery, yes vs no
Measured: Measurement at 12 weeks
Balance test
Part of short physical performance battery, yes vs no
Measured: Measurement at 24 weeks
Energy intake
Energy in kilocalories per 24 hours
Measured: Measurement at discharge, baseline
Energy intake
Energy in kilocalories per 24 hours
Measured: Measurement at 12 weeks
Energy intake
Energy in kilocalories per 24 hours
Measured: Measurement at 24 weeks
Protein intake
Protein intake in g/day
Measured: Measurement at 12 weeks
Protein intake
Protein intake in g/day
Measured: Measurement at discharge, baseline
Protein intake
Protein intake in g/day
Measured: Measurement at 24 weeks
Fluid intake
Fluid intake evaluated
Measured: Measurement at discharge, baseline
Fluid intake
Fluid intake evaluated
Measured: Measurement at 12 weeks
Fluid intake
Fluid intake evaluated
Measured: Measurement at 24 weeks
Upper arm circumference
Measured in centimeters
Measured: Measurement at discharge, baseline
Upper arm circumference
Measured in centimeters
Measured: Measurement at 24 weeks
Waist circumference
Measured in centimeters
Measured: Measurement at discharge, baseline
Waist circumference
Measured in centimeters
Measured: Measurement at 24 weeks
calf circumference
Measured in centimeters
Measured: Measurement at discharge, baseline
calf circumference
Measured in centimeters
Measured: Measurement at 24 weeks
lean body mass
Measured with BIA (kg)
Measured: Measurement at discharge, baseline
lean body mass
Measured with BIA (kg)
Measured: Measurement at 24 weeks
Grip strength
Measured in kg
Measured: Measurement at discharge, baseline
Grip strength
Measured in kg
Measured: Measurement at 12 weeks
Grip strength
Measured in lbs
Measured: Measurement at 24 weeks
Health Related Quality of Life (HRQL)
EQ-5D including SRH
Measured: Measurement at discharge, baseline
Health Related Quality of Life (HRQL)
EQ-5D including SRH
Measured: Measurement at 12 weeks
Health Related Quality of Life (HRQL)
EQ-5D including SRH
Measured: Measurement at 24 weeks
Depression
Center for Epidemiologic Studies Depression scale
Measured: Measurement at discharge, baseline
Depression
Center for Epidemiologic Studies Depression scale
Measured: Measurement at 24 weeks
Cognitive function
MMSE
Measured: Measurement at discharge, baseline
Cognitive function
MMSE
Measured: Measurement at 24 weeks
Nutrition status
Icelandic Nutrition Screening Tool (score)
Measured: Measurement at discharge, baseline.
Nutrition status
Icelandic Nutrition Screening Tool (score)
Measured: Measurement at 24 weeks
Secondary outcomes (2)
Re-hospitalization
Number of participants who were re-hospitalized
Measured: at 12 months from recruitment to trial
Mortality
Number of participants who deceased
Measured: at 12 months from recruitment to trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start1 Jan 2019
- Primary completion26 Aug 2020
- Study completion26 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfons Ramel, University of Iceland
- Investigators
- Alfons Ramel, Ph.D., Principal investigator, University of IcelandOlof G Geirsdottir, Ph.D., Principal investigator, University of IcelandBerglind S Blondal, MSc, Principal investigator, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995303
- Sponsor's protocol ID
- UI-2018-HOMEFOOD
- Acronym
- HOMEFOOD
- Status last verified
- Nov 2021
- First submitted
- 9 Jan 2019
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39151910Blondal 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.
PubMed 36028775
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOMEFOOD Study - Home Delivered Food and Nutrition Therapy for Discharged Geriatric Hospital Patients
- ClinicalTrials.gov ID
- NCT03995303
- Acronym / sponsor ID
- HOMEFOOD / UI-2018-HOMEFOOD
- Conditions
- Malnutrition
- Keywords
- Malnutrition, Old adults, Home-delivered meals, NCP - Nutrition Care Process, Food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 26 Aug 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 24 Jun 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NCP and home-delivered meals | Active comparator | Other: NCP and home-delivered mealsPreventing malnutrition with NCP by a registered dietician and home-delivered meals |
| Current practice | No intervention | –Current practice after discharge from the University Hospital of Iceland. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Living at a nursing home
- MMSE score of under 20
- No nutritional risk
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 |
|---|---|---|
| NCP and home-delivered mealsAlso: NCP and delivered mealsThe 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. | Other | NCP and home-delivered meals |
Primary outcome
Body weight
Time frame: Measurement at discharge, baseline
Body weight in kilograms
Body weight
Time frame: Measurement at 12 weeks
Body weight in kilograms
Body weight
Time frame: Measurement at 24 weeks
Body weight in kilograms
Five Times Sit to Stand Test
Time frame: Measurement at discharge, baseline
Part of short physical performance battery, yes vs no
Five Times Sit to Stand Test
Time frame: Measurement at 12 weeks
Part of short physical performance battery, yes vs no
Five Times Sit to Stand Test
Time frame: Measurement at 24 weeks
Part of short physical performance battery, yes vs no
Balance test
Time frame: Measurement at discharge, baseline
Part of short physical performance battery, yes vs no
Balance test
Time frame: Measurement at 12 weeks
Part of short physical performance battery, yes vs no
Balance test
Time frame: Measurement at 24 weeks
Part of short physical performance battery, yes vs no
Energy intake
Time frame: Measurement at discharge, baseline
Energy in kilocalories per 24 hours
Energy intake
Time frame: Measurement at 12 weeks
Energy in kilocalories per 24 hours
Energy intake
Time frame: Measurement at 24 weeks
Energy in kilocalories per 24 hours
Protein intake
Time frame: Measurement at 12 weeks
Protein intake in g/day
Protein intake
Time frame: Measurement at discharge, baseline
Protein intake in g/day
Protein intake
Time frame: Measurement at 24 weeks
Protein intake in g/day
Fluid intake
Time frame: Measurement at discharge, baseline
Fluid intake evaluated
Fluid intake
Time frame: Measurement at 12 weeks
Fluid intake evaluated
Fluid intake
Time frame: Measurement at 24 weeks
Fluid intake evaluated
Upper arm circumference
Time frame: Measurement at discharge, baseline
Measured in centimeters
Upper arm circumference
Time frame: Measurement at 24 weeks
Measured in centimeters
Waist circumference
Time frame: Measurement at discharge, baseline
Measured in centimeters
Waist circumference
Time frame: Measurement at 24 weeks
Measured in centimeters
calf circumference
Time frame: Measurement at discharge, baseline
Measured in centimeters
calf circumference
Time frame: Measurement at 24 weeks
Measured in centimeters
lean body mass
Time frame: Measurement at discharge, baseline
Measured with BIA (kg)
lean body mass
Time frame: Measurement at 24 weeks
Measured with BIA (kg)
Grip strength
Time frame: Measurement at discharge, baseline
Measured in kg
Grip strength
Time frame: Measurement at 12 weeks
Measured in kg
Grip strength
Time frame: Measurement at 24 weeks
Measured in lbs
Health Related Quality of Life (HRQL)
Time frame: Measurement at discharge, baseline
EQ-5D including SRH
Health Related Quality of Life (HRQL)
Time frame: Measurement at 12 weeks
EQ-5D including SRH
Health Related Quality of Life (HRQL)
Time frame: Measurement at 24 weeks
EQ-5D including SRH
Depression
Time frame: Measurement at discharge, baseline
Center for Epidemiologic Studies Depression scale
Depression
Time frame: Measurement at 24 weeks
Center for Epidemiologic Studies Depression scale
Cognitive function
Time frame: Measurement at discharge, baseline
MMSE
Cognitive function
Time frame: Measurement at 24 weeks
MMSE
Nutrition status
Time frame: Measurement at discharge, baseline.
Icelandic Nutrition Screening Tool (score)
Nutrition status
Time frame: Measurement at 24 weeks
Icelandic Nutrition Screening Tool (score)
2 secondary outcomes
Re-hospitalization
Time frame: at 12 months from recruitment to trial
Mortality
Time frame: at 12 months from recruitment to trial
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 17 Nov 2021.
- Derived from this study: PubMed 39151910Eymundsdottir 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.
- Derived from this study: PubMed 36028775Blondal 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.
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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.
Alfons Ramel, Ph.D. principal investigator
University of Iceland
Olof G Geirsdottir, Ph.D. principal investigator
University of Iceland
Berglind S Blondal, MSc principal investigator
University of Iceland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NCP and home-delivered meals in people with Malnutrition, run by University of Iceland at 1 site in Iceland.
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 3 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 17 Nov 2021. 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 Iceland. 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. 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?
Body weight (time frame: Measurement at discharge, baseline). The study lists 38 primary outcomes in all. 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 NCT03995303, which also lists 2 linked publications.
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 17 Nov 2021.