The Impact of Preoperative FoodforCare at Home

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Preoperative FoodforCare at Home on Nutritional and Functional Outcomes

Conditions
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Surgery

Intervention / Treatment
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* Other: FoodforCare at home


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 18 years or older surgical patients living within a 40 km radius around Nijmegen/Veghel inclusion at least 4 weeks before surgery surgery: Urology, Orthopedics, Gynaecology, General Surgery oral intake Exclusion criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Other: FoodforCare at home<br>* Six small protein rich meals that will be delivered twice a week for 3 weeks.<br>|
| No Intervention: Control group<br>The control group will continue their usual diet for 3 weeks and have no restrictions to their diet. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein intake relative to requirements | 3-day food diary filled in at baseline and after 3 weeks. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | Patient Generated Subjective Global Assessment (PG-SGA) performed at baseline and after 3 weeks. | 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. | 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). | 3 weeks | 
| Length of stay | These are determined retrospectively in the electronic patient file EPIC 2 months after baseline | 2 months | 
| Readmissions | These are determined retrospectively in the electronic patient file EPIC 2 months after baseline | 2 months | 
| Postoperative complications | This is reported using a standardized classification system 2 months after baseline | 2 months | 
| Energy intake relative to requirements | 3-day food diary filled in at baseline and after 3 weeks. | 3 weeks | 
| Functional status | Short Physical Performance Battery (SPPB) performed at baseline and after 3 weeks. | 3 weeks | 
| Muscle strength | Hand grip strength (kg) performed at baseline and at 3 weeks. | 3 weeks |