The Impact of Preoperative FoodforCare at Home

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.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Other: FoodforCare at home

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 Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboudumc
  • Noord-Brabant
    • Beugen, Noord-Brabant, Netherlands, 5835DV
      • Maasziekenhuis Pantein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; Six small protein rich meals that will be delivered twice a week for 3 weeks.
No Intervention: Control group; The control group will continue their usual diet for 3 weeks and have no restrictions to their diet.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Study Chair: Manon van den Berg, PhD, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2018
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2016-3043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No