SurgeryNCT03488511
The Impact of Preoperative FoodforCare at Home
A study testing FoodforCare at home in people with Surgery, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
Preoperative nutritional state is closely related to perioperative morbidity and complications. This study aims to determine the effect of a protein-rich meal service in the preoperative setting compared to usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- FoodforCare at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 2 sitesNetherlands
- Study dates
- 5 Mar 2018to 1 Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- surgical patients
- living within a 40 km radius around Nijmegen/Veghel
- surgery: Urology, Orthopedics, Gynaecology, General Surgery
- oral intake
Who cannot join
- renal insufficiency (MDRD-GFR (glomerular filtration rate) < 60ml/min and/or proteinuria)*
- food allergy
- planned vacation during intervention period
- proteinuria is defined in case of a protein creatinine ratio > 0.5g/10mmol or an albuminuria > 300mg/day.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Maasziekenhuis Pantein
Beugen, North Brabant, 5835DV
Radboudumc
Nijmegen, Gelderland, 6525 GA
About this study
Official title: The Impact of Preoperative FoodforCare at Home on Nutritional and Functional Outcomes
Preoperative nutritional state is closely related to perioperative morbidity and complications. This study aims to determine the effect of a protein-rich meal service in the preoperative setting compared to usual care.
Read the detailed description
Each year, approximately 1.4 million patients in the Netherlands are operated. Adequate nutritional intake, mainly protein intake, before surgery is important to improve preoperative muscle strength and functional capacity. However, up to 40% of patients admitted to the hospital suffer from malnutrition and this further deepened during hospitalization, which is an independent risk factor for peri-operative morbidity and severe complications, ranging from increased muscle loss, to higher infection rates, delayed wound healing and subsequently a prolonged hospital stay. An adequate food service is one strategy to improve protein intake and thereby the nutritional status. Extension of the study period to the out-of-hospital setting is recommended to explore the effects of long-term exposure to this concept on nutritional, functional and clinical outcomes. Therefore, the investigators aim to evaluate whether home delivered protein-rich meals, as part of FoodforCare meal service, in the preoperative setting improves protein intake in patients undergoing surgery, compared to usual care. The second aim is to investigate the effects on functional and clinical outcomes.
- Conditions
- Surgery
- Being tested
- FoodforCare at home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoodforCare at homeOther
Six small protein rich meals that will be delivered twice a week for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive meals from FoodforCare at Home. The FoodforCare at Home concept consists of six small protein and energy enriched meals and snacks that will be delivered twice a week. After an individual intake, the composition of the dishes will be tailored to the needs of the patient in terms of composition, diet, taste, flavor and portion size. Besides the meals, patients in the intervention group will also receive an information leaflet about the importance of protein during treatment and how to reach their protein requirements. Receives: Other: FoodforCare at home |
| Control group | No intervention | The control group will continue their usual diet for 3 weeks and have no restrictions to their diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein intake relative to requirements
3-day food diary filled in at baseline and after 3 weeks.
Measured: 3 weeks
Secondary outcomes (9)
Nutritional status
Patient Generated Subjective Global Assessment (PG-SGA) performed at baseline and after 3 weeks.
Measured: 3 weeks
Quality of life and overall health status
ShortForm-36 questionnaire filled in at baseline and after 3 weeks. This questionnaire consists of 36 questions about physical and psychological aspects. Each item is scored on a 0 to 100 range. The higher the score, the higher the quality of life of the patient.
Measured: 3 weeks
Patient satisfaction
Questionnaire filled in after 3 weeks of receiving meals. This is a self-developed questionnaire which does not have a total score. Each question will be analyzed separately. Questions consist of grading from 0-10 (the higher, the better the outcome) or with a 5-point Likert scale (completely disagree-completely agree).
Measured: 3 weeks
Length of stay
These are determined retrospectively in the electronic patient file EPIC 2 months after baseline
Measured: 2 months
Readmissions
These are determined retrospectively in the electronic patient file EPIC 2 months after baseline
Measured: 2 months
Postoperative complications
This is reported using a standardized classification system 2 months after baseline
Measured: 2 months
Energy intake relative to requirements
3-day food diary filled in at baseline and after 3 weeks.
Measured: 3 weeks
Functional status
Short Physical Performance Battery (SPPB) performed at baseline and after 3 weeks.
Measured: 3 weeks
Muscle strength
Hand grip strength (kg) performed at baseline and at 3 weeks.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start5 Mar 2018
- Primary completion1 Jun 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manon van den Berg, PhD, Study chair, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488511
- Sponsor's protocol ID
- 2016-3043
- Status last verified
- Apr 2019
- First submitted
- 21 Mar 2018
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Preoperative FoodforCare at Home on Nutritional and Functional Outcomes
- ClinicalTrials.gov ID
- NCT03488511
- Acronym / sponsor ID
- 2016-3043
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 5 Apr 2018 (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.
Preoperative nutritional state is closely related to perioperative morbidity and complications. This study aims to determine the effect of a protein-rich meal service in the preoperative setting compared to usual care.
Detailed description
Each year, approximately 1.4 million patients in the Netherlands are operated. Adequate nutritional intake, mainly protein intake, before surgery is important to improve preoperative muscle strength and functional capacity. However, up to 40% of patients admitted to the hospital suffer from malnutrition and this further deepened during hospitalization, which is an independent risk factor for peri-operative morbidity and severe complications, ranging from increased muscle loss, to higher infection rates, delayed wound healing and subsequently a prolonged hospital stay. An adequate food service is one strategy to improve protein intake and thereby the nutritional status. Extension of the study period to the out-of-hospital setting is recommended to explore the effects of long-term exposure to this concept on nutritional, functional and clinical outcomes. Therefore, the investigators aim to evaluate whether home delivered protein-rich meals, as part of FoodforCare meal service, in the preoperative setting improves protein intake in patients undergoing surgery, compared to usual care. The second aim is to investigate the effects on functional and clinical outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: FoodforCare at homeThe intervention group will receive meals from FoodforCare at Home. The FoodforCare at Home concept consists of six small protein and energy enriched meals and snacks that will be delivered twice a week. After an individual intake, the composition of the dishes will be tailored to the needs of the patient in terms of composition, diet, taste, flavor and portion size. Besides the meals, patients in the intervention group will also receive an information leaflet about the importance of protein during treatment and how to reach their protein requirements. |
| Control group | No intervention | –The control group will continue their usual diet for 3 weeks and have no restrictions to their diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- surgical patients
- living within a 40 km radius around Nijmegen/Veghel
- surgery: Urology, Orthopedics, Gynaecology, General Surgery
- oral intake
Key exclusion criteria (4 listed)
- renal insufficiency (MDRD-GFR (glomerular filtration rate) < 60ml/min and/or proteinuria)*
- food allergy
- planned vacation during intervention period
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 |
|---|---|---|
| FoodforCare at homeSix small protein rich meals that will be delivered twice a week for 3 weeks. | Other | Intervention group |
Primary outcome
Protein intake relative to requirements
Time frame: 3 weeks
3-day food diary filled in at baseline and after 3 weeks.
9 secondary outcomes
Nutritional status
Time frame: 3 weeks
Quality of life and overall health status
Time frame: 3 weeks
Patient satisfaction
Time frame: 3 weeks
Length of stay
Time frame: 2 months
Readmissions
Time frame: 2 months
Postoperative complications
Time frame: 2 months
Energy intake relative to requirements
Time frame: 3 weeks
Functional status
Time frame: 3 weeks
Muscle strength
Time frame: 3 weeks
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 19 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Manon van den Berg, PhD study chair
Radboud University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FoodforCare at home in people with Surgery, run by Radboud University Medical Center at 2 sites in Netherlands.
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 5 inclusion and 4 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 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Protein intake relative to requirements (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2020.