The Impact of Preoperative FoodforCare at Home
1 other identifier
interventional
126
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable surgery
Started Mar 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 5, 2018
CompletedFirst Submitted
Initial submission to the registry
March 21, 2018
CompletedFirst Posted
Study publicly available on registry
April 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedFebruary 19, 2020
April 1, 2019
1.2 years
March 21, 2018
February 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Protein intake relative to requirements
3-day food diary filled in at baseline and after 3 weeks.
3 weeks
Secondary Outcomes (9)
Nutritional status
3 weeks
Quality of life and overall health status
3 weeks
Patient satisfaction
3 weeks
Length of stay
2 months
Readmissions
2 months
- +4 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALThe 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.
Control group
NO INTERVENTIONThe control group will continue their usual diet for 3 weeks and have no restrictions to their diet.
Interventions
Six small protein rich meals that will be delivered twice a week for 3 weeks.
Eligibility Criteria
You may qualify if:
- years or older
- surgical patients
- living within a 40 km radius around Nijmegen/Veghel
- surgery: Urology, Orthopedics, Gynaecology, General Surgery
- oral intake
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Radboudumc
Nijmegen, Gelderland, 6525 GA, Netherlands
Maasziekenhuis Pantein
Beugen, North Brabant, 5835DV, Netherlands
Study Officials
- STUDY CHAIR
Manon van den Berg, PhD
Radboud University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2018
First Posted
April 5, 2018
Study Start
March 5, 2018
Primary Completion
June 1, 2019
Study Completion
September 1, 2019
Last Updated
February 19, 2020
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share