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Introduction of an Enriched Evening Meal on the Feeding Behavior of Institutionalized Residents (IRCAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02329613
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief Summary:
The main objective of this study was to evaluate and compare 6-month calorie intakes between a group of patients receiving a standard dinner and a group of patients whose evening meal is "improved"; compliance will be assessed on a food card with 5 levels of consumption: no (0%), 25%, 50%, 75%, all (100%). This per patient per meal food card will be prepared 3 days per month for 6 months and will, from the total calorie intake of each dish, estimate calorie intake ingested per day on all meals of the day.

Condition or disease Intervention/treatment Phase
Institutionalization Other: Standard evening meals. Other: Improved evening meal Not Applicable

Detailed Description:

The secondary objectives of this study are to evaluate the two groups for the following:

A. The difference between 0 and 6 months in: the patient's weight, calorie intake, serum prealbumin, albumin and CRP, blood sugar for diabetic patients.

B. Monthly evolution over 6 months: calorie intake, the patient's weight. C. The quarterly trend over 6 months: serum prealbumin, albumin and CRP, blood sugar for diabetic patients.

D. Comorbidities and mortality. E. the risk of morning hypoglycaemia for diabetic patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of the Introduction of a New Qualitative Composition of the Evening Meal on the Feeding Behavior of Institutionalized Residents of a Long-term Care Unit: a Randomized, Single Center Study
Study Start Date : April 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Active Comparator: Standard evening meal

Patients randomized to this arm will receive standard evening meals.

Intervention: Standard evening meals.

Other: Standard evening meals.
Patients will receive usual evening meals.

Experimental: Improved evening meal

Patients randomized to this arm will receive improved evening meals. Improved meals will include enriched soup (with starches, butter, cheese or sour cream), a semi-liquid dairy dessert, fruit or a fruit dessert.

Intervention: Improved evening meal

Other: Improved evening meal
Patients will receive improved evening meals. Improved meals will include enriched soup (with starches, butter, cheese or sour cream), a semi-liquid dairy dessert, fruit or a fruit dessert.




Primary Outcome Measures :
  1. Total caloric ration for each dish [ Time Frame: 6 months ]
  2. Meal compliance for 3 days [ Time Frame: 6 months ]
  3. Ingested caloric intake [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Total caloric ration for each dish [ Time Frame: Baseline (days -7 to 0) ]
  2. Total caloric ration for each dish [ Time Frame: Month 1 ]
  3. Total caloric ration for each dish [ Time Frame: Month 2 ]
  4. Total caloric ration for each dish [ Time Frame: Month 3 ]
  5. Total caloric ration for each dish [ Time Frame: Month 4 ]
  6. Total caloric ration for each dish [ Time Frame: Month 5 ]
  7. Meal compliance for 3 days [ Time Frame: Baseline (days -7 to 0) ]
  8. Meal compliance for 3 days [ Time Frame: Month 1 ]
  9. Meal compliance for 3 days [ Time Frame: Month 2 ]
  10. Meal compliance for 3 days [ Time Frame: Month 3 ]
  11. Meal compliance for 3 days [ Time Frame: Month 4 ]
  12. Meal compliance for 3 days [ Time Frame: Month 5 ]
  13. Ingested caloric intake [ Time Frame: Baseline (days -7 to 0) ]
  14. Ingested caloric intake [ Time Frame: Month 1 ]
  15. Ingested caloric intake [ Time Frame: Month 2 ]
  16. Ingested caloric intake [ Time Frame: Month 3 ]
  17. Ingested caloric intake [ Time Frame: Month 4 ]
  18. Ingested caloric intake [ Time Frame: Month 5 ]
  19. Weight (kg) [ Time Frame: Baseline (days -7 to 0) ]
  20. Weight (kg) [ Time Frame: Month 1 ]
  21. Weight (kg) [ Time Frame: Month 2 ]
  22. Weight (kg) [ Time Frame: Month 3 ]
  23. Weight (kg) [ Time Frame: Month 4 ]
  24. Weight (kg) [ Time Frame: Month 5 ]
  25. Weight (kg) [ Time Frame: Month 6 ]
  26. Serum prealbumin [ Time Frame: Baseline (days -7 to 0) ]
  27. Serum prealbumin [ Time Frame: Month 3 ]
  28. Serum prealbumin [ Time Frame: Month 6 ]
  29. Serum albumin [ Time Frame: Baseline (days -7 to 0) ]
  30. Serum albumin [ Time Frame: Month 3 ]
  31. Serum albumin [ Time Frame: Month 6 ]
  32. Serum C reactive protein [ Time Frame: Baseline (days -7 to 0) ]
  33. Serum C reactive protein [ Time Frame: Month 3 ]
  34. Serum C reactive protein [ Time Frame: Month 6 ]
  35. Glycated hemoglobin (HbA1C) for diabetic patients [ Time Frame: Baseline (days -7 to 0) ]
  36. Glycated hemoglobin (HbA1C) for diabetic patients [ Time Frame: Month 3 ]
  37. Glycated hemoglobin (HbA1C) for diabetic patients [ Time Frame: Month 6 ]
  38. Presence/absence of comorbidities [ Time Frame: Month 6 ]
  39. Mortality [ Time Frame: Month 6 ]
  40. Capillary fasting blood glucose for diabetic patients [ Time Frame: Month 1 ]
  41. Capillary fasting blood glucose for diabetic patients [ Time Frame: Month 2 ]
  42. Capillary fasting blood glucose for diabetic patients [ Time Frame: Month 3 ]
  43. Capillary fasting blood glucose for diabetic patients [ Time Frame: Month 4 ]
  44. Capillary fasting blood glucose for diabetic patients [ Time Frame: Month 5 ]
  45. Capillary fasting blood glucose for diabetic patients [ Time Frame: Month 6 ]


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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject or his/her representative must be given free and informed consent and must have signed the consent
  • The subject must be affiliated with or beneficiary of a health insurance plan
  • The subject has lived for at least 3 months in the institution
  • The subject is fed by mouth only

Exclusion Criteria:

  • The subject is participating in another study
  • The subject is in an exclusion period determined by a previous study
  • The subject or his/her legal representative refuses to sign the consent
  • It is not possible to correctly inform the subject or his/her representative

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): NCT02329613


Locations
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France
CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier
Nîmes, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Sabine Rouvière, MD Centre Hospitalier Universitaire de Nîmes
Study Director: Béatrice Hébert, Nurse Centre Hospitalier Universitaire de Nîmes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02329613    
Other Study ID Numbers: LOCAL/2014/BH-01
2014-A00509-38 ( Other Identifier: RCB number )
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: April 2016