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The Impact of Preoperative FoodforCare at Home

R

Radboud University Medical Center

Status

Completed

Conditions

Surgery

Treatments

Other: FoodforCare at home

Study type

Interventional

Funder types

Other

Identifiers

NCT03488511
2016-3043

Details and patient eligibility

About

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.

Full 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.

Enrollment

126 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

126 participants in 2 patient groups

Intervention group
Experimental group
Description:
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.
Treatment:
Other: FoodforCare at home
Control group
No Intervention group
Description:
The control group will continue their usual diet for 3 weeks and have no restrictions to their diet.

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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