Back to results

Does the Access to Small Delicious Dishes, Have a Positive Effect on Nutritional Intake in Patients at Nutritional Risk? (SGG)

Primary Purpose

Malnutrition

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Nutritional intervention

About this trial

This is an interventional supportive care trial for Malnutrition focused on measuring Nutrition, new energy dense food concept

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients at nutritional risk, according to the NRS-2002 criteria.
patient must be able to understand the information and be able to give a written inform consent
well-functioning gastrointestinal tract
Anticipated length of hospitalization > 5 days
Should understand and speak danish

Exclusion Criteria:

Terminal patients
patients with dysphagia
patient with food allergy or intolerance
patients who only receives enteral or parenteral nutrition

Sites / Locations

Copenhagen University Hospital at Herlev

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nutritional intervention

Arm Description

Outcomes

Primary Outcome Measures

Change in energy and protein intake compared to the historical control group

The patient's energy requirement was estimated both from the factorial method and by Harris and Benedicts formula and the protein requirements was taken to be 18 E % of the energy requirement. Recording of the dietary intake was carried out on a daily basis over a period of 3 to 7 days, with nutritional registration forms filled in by the nurse and/or the patient. The nutritional registration forms contained information of the energy and protein content of the food

Secondary Outcome Measures

Full Information

NCT ID

NCT01322087

First Posted

March 17, 2011

Last Updated

March 23, 2011

Sponsor

Copenhagen University Hospital at Herlev

1. Study Identification

Unique Protocol Identification Number

NCT01322087

Brief Title

Does the Access to Small Delicious Dishes, Have a Positive Effect on Nutritional Intake in Patients at Nutritional Risk?

Acronym

SGG

Official Title

Does the Access to Small Delicious Dishes, 24 Hours a Day, Have a Positive Effect on Nutritional Intake in Patients at Nutritional Risk?

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Copenhagen University Hospital at Herlev

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Rationale: The objective of this study was to investigate whether a new energy dense food concept, on order 24 hours a day, would lead to a minimum 75% intake of nutritional needs in patients at nutritional risk. The investigators target was for 70% of patients to reach 75% of their energy and protein requirements. Methods: An intervention study was conducted with inclusion of 40 patients at nutritional risk, according to the NRS-2002 criteria. The food concept consisted of 36 small delicious dishes. Patients could choose food from both the new concept and the ordinary patient buffet. The investigators monitored patients' nutritional requirements and daily nutritional intake.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malnutrition

Keywords

Nutrition, new energy dense food concept

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nutritional intervention

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

Nutritional intervention

Intervention Description

The study was a 12 weeks intervention trial with inclusion of 40 patients at nutritional risk, according to the NRS-2002 system. All included patients received nutritional counseling and information about the new food concept by a clinical dietician. Recording of the dietary intake was carried out on a daily basis over a period of 3 to 7 days, with nutritional registration forms filled in by the nurse and/or the patient.

Primary Outcome Measure Information:

Title

Change in energy and protein intake compared to the historical control group

Description

Time Frame

3 to 7 days recording of dietary intake

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients at nutritional risk, according to the NRS-2002 criteria. patient must be able to understand the information and be able to give a written inform consent well-functioning gastrointestinal tract Anticipated length of hospitalization > 5 days Should understand and speak danish Exclusion Criteria: Terminal patients patients with dysphagia patient with food allergy or intolerance patients who only receives enteral or parenteral nutrition

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tina Munk, MSc.

Organizational Affiliation

Copenhagen University Hospital at Herlev

Official's Role

Principal Investigator

Facility Information:

Facility Name

Copenhagen University Hospital at Herlev

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

Does the Access to Small Delicious Dishes, Have a Positive Effect on Nutritional Intake in Patients at Nutritional Risk?

We'll reach out to this number within 24 hrs