An interventional study of FoodforCare at home in Surgery, sponsored by Radboud University Medical Center. Completed at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-19.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Supportive care
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.
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.
Inclusion criteria:
Exclusion criteria:
planned vacation during intervention period
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
The control group will continue their usual diet for 3 weeks and have no restrictions to their diet.
Six small protein rich meals that will be delivered twice a week for 3 weeks.
Protein intake relative to requirements
3-day food diary filled in at baseline and after 3 weeks.
Time frame: 3 weeks
Nutritional status
Patient Generated Subjective Global Assessment (PG-SGA) performed at baseline and after 3 weeks.
Time frame: 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.
Time frame: 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).
Time frame: 3 weeks
Length of stay
These are determined retrospectively in the electronic patient file EPIC 2 months after baseline
Time frame: 2 months
Readmissions
These are determined retrospectively in the electronic patient file EPIC 2 months after baseline
Time frame: 2 months
Postoperative complications
This is reported using a standardized classification system 2 months after baseline
Time frame: 2 months
Energy intake relative to requirements
3-day food diary filled in at baseline and after 3 weeks.
Time frame: 3 weeks
Functional status
Short Physical Performance Battery (SPPB) performed at baseline and after 3 weeks.
Time frame: 3 weeks
Muscle strength
Hand grip strength (kg) performed at baseline and at 3 weeks.
Time frame: 3 weeks
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Plan to share: No
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center