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Cater With Care Effect Study (CwC)

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ClinicalTrials.gov Identifier: NCT02213393
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
Wageningen University

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.

Condition or disease Intervention/treatment Phase
Undernutrition Dietary Supplement: Protein enriched products Dietary Supplement: Usual menu Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Protein enriched products
The intervention group receives protein enriched products (CwC products) in the hospital and receives these also after discharge during 12 weeks.
Dietary Supplement: Protein enriched products
The intervention group receives CwC protein enriched products. After discharge the intervention group receives CwC products delivered at home for 12 weeks.
Other Name: CwC products

Active Comparator: Usual menu
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.
Dietary Supplement: Usual menu
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 Measures :
  1. Change from Baseline Protein intake and Physical functioning at 6 months [ Time Frame: 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 :
  1. Change in muscle strength from baseline to 6 months. [ Time Frame: 6 months ]
    Muscle strength (leg and hand grip) will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.

  2. Change in nutritional status from baseline to 6 months. [ Time Frame: 6 months ]
    Nutritional status (MNA and dietary intake) will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.

  3. Change in Quality of Life from baseline to 6 months. [ Time Frame: 6 months. ]
    Quality of Life will be assessed with the EuroQoL-5D-5L (at baseline, and 12 and 24 weeks after hospital discharge)

  4. Change in Activities of Daily Living from baseline to 6 months. [ Time Frame: 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).


Other Outcome Measures:
  1. BMI [ Time Frame: 6 months ]
    BMI is calculated from weight and length measurements at baseline (0), 2, 6, 12, 24 weeks after hospital discharge.

  2. Physical Activity [ Time Frame: 6 months ]
    Physical Activity will be assessed by using the LAPAQ questionnaire.

  3. Length of hospital stay [ Time Frame: 12 weeks ]
    The length of hospital stay will be recorded to include in an economic evaluation.

  4. Costs of hospital stay [ Time Frame: 12 weeks ]
    After discharge from the hospital, the costs of hospital stay will be calculated to include in the economic evaluation.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213393


Locations
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Netherlands
Hospital Gelderse Vallei
Ede, Gelderland, Netherlands, 6716 RP
Sponsors and Collaborators
Wageningen University
Investigators
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Principal Investigator: Nicole M de Roos, PhD Wageningen University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT02213393     History of Changes
Other Study ID Numbers: NL48893.081.14
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015
Keywords provided by Wageningen University:
undernutrition
nutritional status
elderly patients
protein
enriched products
recovery
physical function
quality of life
activities of daily living
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders