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InstitutionalizationIRCARNCT02329613

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

A study testing Standard evening meals. and Improved evening meal in people with Institutionalization, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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%). Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Institutionalization
What is being tested?
Standard evening meals. and Improved evening meal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteFrance
Study dates
Apr 2015to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier

    Nîmes, 30029

Other trials in France

About this study

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

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.

Read the detailed description

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

  1. The difference between 0 and 6 months in: the patient's weight, calorie intake, serum prealbumin, albumin and CRP, blood sugar for diabetic patients.
  2. 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.
  3. Comorbidities and mortality. E. the risk of morning hypoglycaemia for diabetic patients.
Being tested
Standard evening meals., Improved evening meal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard evening meals.Other

    Patients will receive usual evening meals.

  • Improved evening mealOther

    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.

Study groups in NCT02329613
Study groupRoleWhat they receive
Standard evening mealActive comparatorPatients randomized to this arm will receive standard evening meals. Intervention: Standard evening meals.
Receives: Other: Standard evening meals.
Improved evening mealExperimentalPatients 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
Receives: Other: Improved evening meal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total caloric ration for each dish

    Measured: 6 months

  2. Meal compliance for 3 days

    Measured: 6 months

  3. Ingested caloric intake

    Measured: 6 months

Secondary outcomes (45)

  1. Total caloric ration for each dish

    Measured: Baseline (days -7 to 0)

  2. Total caloric ration for each dish

    Measured: Month 1

  3. Total caloric ration for each dish

    Measured: Month 2

  4. Total caloric ration for each dish

    Measured: Month 3

  5. Total caloric ration for each dish

    Measured: Month 4

  6. Total caloric ration for each dish

    Measured: Month 5

  7. Meal compliance for 3 days

    Measured: Baseline (days -7 to 0)

  8. Meal compliance for 3 days

    Measured: Month 1

  9. Meal compliance for 3 days

    Measured: Month 2

  10. Meal compliance for 3 days

    Measured: Month 3

  11. Meal compliance for 3 days

    Measured: Month 4

  12. Meal compliance for 3 days

    Measured: Month 5

  13. Ingested caloric intake

    Measured: Baseline (days -7 to 0)

  14. Ingested caloric intake

    Measured: Month 1

  15. Ingested caloric intake

    Measured: Month 2

  16. Ingested caloric intake

    Measured: Month 3

  17. Ingested caloric intake

    Measured: Month 4

  18. Ingested caloric intake

    Measured: Month 5

  19. Weight (kg)

    Measured: Baseline (days -7 to 0)

  20. Weight (kg)

    Measured: Month 1

  21. Weight (kg)

    Measured: Month 2

  22. Weight (kg)

    Measured: Month 3

  23. Weight (kg)

    Measured: Month 4

  24. Weight (kg)

    Measured: Month 5

  25. Weight (kg)

    Measured: Month 6

  26. Serum prealbumin

    Measured: Baseline (days -7 to 0)

  27. Serum prealbumin

    Measured: Month 3

  28. Serum prealbumin

    Measured: Month 6

  29. Serum albumin

    Measured: Baseline (days -7 to 0)

  30. Serum albumin

    Measured: Month 3

  31. Serum albumin

    Measured: Month 6

  32. Serum C reactive protein

    Measured: Baseline (days -7 to 0)

  33. Serum C reactive protein

    Measured: Month 3

  34. Serum C reactive protein

    Measured: Month 6

  35. Glycated hemoglobin (HbA1C) for diabetic patients

    Measured: Baseline (days -7 to 0)

  36. Glycated hemoglobin (HbA1C) for diabetic patients

    Measured: Month 3

  37. Glycated hemoglobin (HbA1C) for diabetic patients

    Measured: Month 6

  38. Presence/absence of comorbidities

    Measured: Month 6

  39. Mortality

    Measured: Month 6

  40. Capillary fasting blood glucose for diabetic patients

    Measured: Month 1

  41. Capillary fasting blood glucose for diabetic patients

    Measured: Month 2

  42. Capillary fasting blood glucose for diabetic patients

    Measured: Month 3

  43. Capillary fasting blood glucose for diabetic patients

    Measured: Month 4

  44. Capillary fasting blood glucose for diabetic patients

    Measured: Month 5

  45. Capillary fasting blood glucose for diabetic patients

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2014 (estimated)
  2. Study startApr 2015
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02329613
Sponsor's protocol ID
LOCAL/2014/BH-01
Other IDs
2014-A00509-38
Acronym
IRCAR
Status last verified
Apr 2016
First submitted
29 Dec 2014
Last updated
24 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Standard evening meals. and Improved evening meal in people with Institutionalization, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total caloric ration for each dish (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02329613.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2016.

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