Novel Meal Service Improves Nutritional Intake

June 21, 2017 updated by: Radboud University Medical Center

A Novel In-hospital Meal Service Improves Protein and Energy Intake

This study aims to investigate whether a novel meal service FoodforCare (FfC), comprising 6-protein-rich meals a day following proactive advice from a nutritional assistant, improves dietary intake and patient satisfaction, compared to the traditional 3-meals a day service (TMS).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators performed a quasi experimental study at medical (Gastroenterology) and surgical (Gynecology, Urology, Orthopedics) wards. Patients were offered TMS (July 2015 - May 2016; n=326) or FfC meal service (after stepwise introduction per ward from January 2016 - December 2016; n=311). Primary outcome was the mean percentage of protein and energy intake relative to requirements, between patients receiving TMS and those receiving FfC, on the first and fourth day of full oral intake. Patient satisfaction comprised rating of the experienced quality of the food and the meal service and by means of a validated questionnaire.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
637

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the Departments of Gastroenterology, Urology/Gynaecology and Orthopedics.

Description

Inclusion Criteria:

  • Dutch speaking
  • Aged 18 years or older
  • Exclusively oral intake
  • Expected hospital stay of at least 1 day

Exclusion Criteria:

  • Patients with tube- or parenteral feeding
  • A language barrier
  • Considered to be too weak to adequately answer our questions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Traditional meal service
TMS consists of three meals served by nutritional assistants throughout the day. Preference for dinner can be indicated in the morning by the individual patient from a menu list with predefined choices for meat, potatoes/rice/pasta and vegetables with various portion sizes.
Other: Meal service
The type of meal service in the hospital (usual care)
FoodforCare
FfC consists of a 6-meals per day service. At bedside, patients are offered one or more small protein-rich dishes from a choice of 3. Nutritional assistants play a key role in recommending and delivering these protein-rich meals and assist patient in choosing the most optimal dish, based on the patient's nutrition order in the electronic patient record.
Other: Meal service
The type of meal service in the hospital (usual care)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Protein intake day 1 (gram)
Time Frame: 1 day
The percentage of protein intake (gram) relative to requirements (1.2 gram/kilogram bodyweight) on the first day of full oral intake.
1 day
Protein intake day 4 (gram)
Time Frame: 4 days
The percentage of protein intake (gram) relative to requirements (1.2 gram/kilogram bodyweight) on the fourth day of full oral intake.
4 days
Energy intake day 1 (kcal)
Time Frame: 1 day
The percentage of energy intake (kcal) relative to requirements (Harris & Benedict formula * 1.3) on the first day of full oral intake.
1 day
Energy intake day 4 (kcal)
Time Frame: 4 days
The percentage of energy intake (kcal) relative to requirements (Harris & Benedict formula * 1.3) on the fourth day of full oral intake.
4 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patients' satisfaction (food appreciation and access to food)
Time Frame: 3 day
Patients completed a questionnaire on food appreciation and experiences regarding food access on the third day of full oral intake in the hospital.
3 day
Patients' satisfaction (food quality and meal service)
Time Frame: 3 day
Patients completed a questionnaire in which they rated the quality of the food and the meal service (scale 0-10) on the third day of full oral intake in the hospital.
3 day
Change in nutritional status (body weight)
Time Frame: 4 days
Body weight (in kg) was measured prior to meals in the morning of the first and fourth day of oral intake.
4 days
Change in nutritional status (handgrip strength)
Time Frame: 4 days
Handgrip strength (in kg) was measured prior to meals in the morning of the first and fourth day of oral intake.
4 days
Nutritional status (height)
Time Frame: 1 day
Height (in cm) was measured prior to meals in the morning of the first day of oral intake.
1 day
Nutritional status (malnutrition universal screening tool)
Time Frame: 1 day
Malnutrition universal screening tool (MUST)) was measured prior to meals in the morning of the first day of oral intake. Weight (kg) and height (cm) will be combined to report BMI in kg/m^2.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radboud University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Geert Wanten, MD, PhD, MSc, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 22, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015-1805

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malnutrition

Clinical Trials on Meal service

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings