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Cater With Care Effect Study (CwC)

Primary Purpose

Undernutrition

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Protein enriched products
Usual menu
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Undernutrition focused on measuring undernutrition, nutritional status, elderly patients, protein, enriched products, recovery, physical function, quality of life, activities of daily living

Eligibility Criteria

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

Inclusion Criteria:

  • Hospital phase:
  • admitted to the wards of Geriatric medicine, Pulmonary Medicine, or Internal Medicine in Hospital Gelderse Vallei
  • aged 65 years or over
  • being eligible for receiving a standard protein enriched menu based on hospital protocol
  • Home phase:
  • included in the hospital phase of the study
  • consent to continue treatment and study participation after hospital discharge

Exclusion Criteria:

  • Hospital phase:
  • unwilling to give consent for gathering data from the medical record or meal service system
  • unable to understand Dutch
  • food allergies, food intolerances or other dietary restrictions that prevents the patient from receiving the standard protein enriched menu or Cater with Care products based on the judgement of a dietician and/or medical staff
  • expected length of hospital stay less than 4 days
  • renal insufficiency (eGFR < 30 ml/min)
  • starting with tube feeding or total parenteral nutrition within 2 days of admission
  • refeeding syndrome score > 0 based on hospital screening tool for refeeding risk
  • delirium at admission
  • receiving palliative care
  • Home phase:
  • going to a nursing home, rehabilitation centre or hospice after hospital discharge
  • cognitive impairment or diagnosed with dementia
  • legally incapacitated

Sites / Locations

  • Hospital Gelderse Vallei

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Protein enriched products

Usual menu

Arm Description

The intervention group receives protein enriched products (CwC products) in the hospital and receives these also after discharge during 12 weeks.

The control group receives the usual protein and energy rich menu in the hospital and receives regular products, no protein enrichment, after discharge during 12 weeks.

Outcomes

Primary Outcome Measures

Change from Baseline Protein intake and Physical functioning at 6 months
This study has 2 primary outcomes: protein intake and physical functioning. These will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.

Secondary Outcome Measures

Change in muscle strength from baseline to 6 months.
Muscle strength (leg and hand grip) will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.
Change in nutritional status from baseline to 6 months.
Nutritional status (MNA and dietary intake) will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.
Change in Quality of Life from baseline to 6 months.
Quality of Life will be assessed with the EuroQoL-5D-5L (at baseline, and 12 and 24 weeks after hospital discharge)
Change in Activities of Daily Living from baseline to 6 months.
Activities of Daily Living (ADL) will be assessed by using the Barthel index (at baseline, and 2, 6, 12 and 24 weeks after hospital discharge).

Full Information

First Posted
August 7, 2014
Last Updated
November 11, 2015
Sponsor
Wageningen University
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1. Study Identification

Unique Protocol Identification Number
NCT02213393
Brief Title
Cater With Care Effect Study
Acronym
CwC
Official Title
Effectiveness of Cater With Care Products in Reaching Recommendations for Protein Intake During and After Hospital Stay and in Improving Functional Status After Hospital Stay in Elderly Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wageningen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective is to study the effectiveness of supplementing a standard hospital and 12-week home menu with protein-enriched Cater with Care products in reaching a protein intake of 1,2-1,5 g/kg body weight/day and in improving functional status after hospital stay in elderly patients.
Detailed Description
Rationale: About 25% of hospitalized elderly patients are at risk of undernutrition at admission. Many hospitals provide an energy and protein enriched diet, extra snacks, and oral nutritional supplements if needed. Still, a considerable part of these patients are unable to meet protein requirements and are still at risk of undernutrition at hospital discharge. This may impair recovery of illness, partly due to loss of muscle mass and physical performance. To improve protein intake, Cater with Care products have been developed: a selection of foods and drinks that are consumed often by elderly persons, but now enriched with protein up to 10 grams per portion. We hypothesize that these products help to reach protein requirements in elderly patients during and after hospital stay and thereby improve their health outcomes. Objective: To study the effectiveness of supplementing a standard hospital and 12-week home menu with protein-enriched Cater with Care products in reaching a protein intake of 1,2-1,5 g/kg/day and in improving functional status after hospital stay in elderly patients. Study design: Randomised Controlled Trial (RCT) with 2 intervention groups and two phases: a hospital phase including all admitted patients and a home phase with a selection of patients. Study population: Patients of 65 years or over who are admitted to the departments of Geriatrics, Pulmonary Disease, or Internal Medicine of Hospital Gelderse Vallei. Intervention: The control group receives the standard hospital menu for elderly at risk of undernutrition (energy and protein rich) and a variety of foods and drinks to be used as part of their home diet for 12 weeks after hospitalization. Foods and drinks for home use are non-enriched variants of Cater with Care products (e.g. normal fruit juice). The intervention group receives Cater with Care protein-enriched foods and drinks during hospital stay (in addition to the standard hospital menu) and at home as part of their home diet for 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undernutrition
Keywords
undernutrition, nutritional status, elderly patients, protein, enriched products, recovery, physical function, quality of life, activities of daily living

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protein enriched products
Arm Type
Experimental
Arm Description
The intervention group receives protein enriched products (CwC products) in the hospital and receives these also after discharge during 12 weeks.
Arm Title
Usual menu
Arm Type
Active Comparator
Arm Description
The control group receives the usual protein and energy rich menu in the hospital and receives regular products, no protein enrichment, after discharge during 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein enriched products
Other Intervention Name(s)
CwC products
Intervention Description
The intervention group receives CwC protein enriched products. After discharge the intervention group receives CwC products delivered at home for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Usual menu
Intervention Description
The control group receives the usual menu, which is energy and protein rich in this elderly patient group. After discharge the control group receives regular products, no protein enrichment, at home for 12 weeks.
Primary Outcome Measure Information:
Title
Change from Baseline Protein intake and Physical functioning at 6 months
Description
This study has 2 primary outcomes: protein intake and physical functioning. These will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in muscle strength from baseline to 6 months.
Description
Muscle strength (leg and hand grip) will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.
Time Frame
6 months
Title
Change in nutritional status from baseline to 6 months.
Description
Nutritional status (MNA and dietary intake) will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.
Time Frame
6 months
Title
Change in Quality of Life from baseline to 6 months.
Description
Quality of Life will be assessed with the EuroQoL-5D-5L (at baseline, and 12 and 24 weeks after hospital discharge)
Time Frame
6 months.
Title
Change in Activities of Daily Living from baseline to 6 months.
Description
Activities of Daily Living (ADL) will be assessed by using the Barthel index (at baseline, and 2, 6, 12 and 24 weeks after hospital discharge).
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
BMI
Description
BMI is calculated from weight and length measurements at baseline (0), 2, 6, 12, 24 weeks after hospital discharge.
Time Frame
6 months
Title
Physical Activity
Description
Physical Activity will be assessed by using the LAPAQ questionnaire.
Time Frame
6 months
Title
Length of hospital stay
Description
The length of hospital stay will be recorded to include in an economic evaluation.
Time Frame
12 weeks
Title
Costs of hospital stay
Description
After discharge from the hospital, the costs of hospital stay will be calculated to include in the economic evaluation.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospital phase: admitted to the wards of Geriatric medicine, Pulmonary Medicine, or Internal Medicine in Hospital Gelderse Vallei aged 65 years or over being eligible for receiving a standard protein enriched menu based on hospital protocol Home phase: included in the hospital phase of the study consent to continue treatment and study participation after hospital discharge Exclusion Criteria: Hospital phase: unwilling to give consent for gathering data from the medical record or meal service system unable to understand Dutch food allergies, food intolerances or other dietary restrictions that prevents the patient from receiving the standard protein enriched menu or Cater with Care products based on the judgement of a dietician and/or medical staff expected length of hospital stay less than 4 days renal insufficiency (eGFR < 30 ml/min) starting with tube feeding or total parenteral nutrition within 2 days of admission refeeding syndrome score > 0 based on hospital screening tool for refeeding risk delirium at admission receiving palliative care Home phase: going to a nursing home, rehabilitation centre or hospice after hospital discharge cognitive impairment or diagnosed with dementia legally incapacitated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole M de Roos, PhD
Organizational Affiliation
Wageningen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Gelderse Vallei
City
Ede
State/Province
Gelderland
ZIP/Postal Code
6716 RP
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
28571713
Citation
Beelen J, Vasse E, Janssen N, Janse A, de Roos NM, de Groot LCPGM. Protein-enriched familiar foods and drinks improve protein intake of hospitalized older patients: A randomized controlled trial. Clin Nutr. 2018 Aug;37(4):1186-1192. doi: 10.1016/j.clnu.2017.05.010. Epub 2017 May 18.
Results Reference
derived

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Cater With Care Effect Study

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