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Completed

NCT Number: NCT03488511

The Impact of Preoperative FoodforCare at Home

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.

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Key information

Conditions

Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboudumc, Nijmegen, Gelderland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FoodforCare at home

Other

Six small protein rich meals that will be delivered twice a week for 3 weeks.

Primary outcomes

  1. Protein intake relative to requirements

    Time frame: 3 weeks

    3-day food diary filled in at baseline and after 3 weeks.

Secondary outcomes

  1. Nutritional status

    Time frame: 3 weeks

    Patient Generated Subjective Global Assessment (PG-SGA) performed at baseline and after 3 weeks.

  2. Quality of life and overall health status

    Time frame: 3 weeks

    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. Patient satisfaction

    Time frame: 3 weeks

    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).

  4. Length of stay

    Time frame: 2 months

    These are determined retrospectively in the electronic patient file EPIC 2 months after baseline

  5. Readmissions

    Time frame: 2 months

    These are determined retrospectively in the electronic patient file EPIC 2 months after baseline

  6. Postoperative complications

    Time frame: 2 months

    This is reported using a standardized classification system 2 months after baseline

  7. Energy intake relative to requirements

    Time frame: 3 weeks

    3-day food diary filled in at baseline and after 3 weeks.

  8. Functional status

    Time frame: 3 weeks

    Short Physical Performance Battery (SPPB) performed at baseline and after 3 weeks.

  9. Muscle strength

    Time frame: 3 weeks

    Hand grip strength (kg) performed at baseline and at 3 weeks.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2018
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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