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The undernourishment and the prevention of its risk at the elderly person in seniors's resident represent a major issue in public health. The diagnosis of undernourishment and its risk are systematically recommended in these structures where the nutrition of these people is a problem because often inappropriate for their capacities of prehension and consequently for their nutritional needs. One of the solutions to remedy can be found in the " finger-food ".
The study FIFO ("Finger-Food") suggests verifying the hypothesis which the finger-food would allow to increase the nutritional intake of the resident who have disorders of the prehension and\or requiring a nutritional stimulation and\or require an help to the preparation of the meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrition with Finger-Food | Experimental | Nutrition with Finger-Food |
|
| Nutrition without Finger-Food | Active Comparator | Nutrition without Finger-Food |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finger-Food | Other | Finger-Food at lunch and having diner |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Measure of Ingesta | Quantitative measure of ingesta (calorie and protein intake) | Monthly: From date of finger-food's implementation until the date of the end of the study (assessed up to 6 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Departemental Vendée | La Roche-sur-Yon | 85925 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nutrition With Finger-Food | Nutrition with Finger-Food Finger-Food: Finger-Food at lunch and having diner |
| FG001 | Nutrition Without Finger-Food | Nutrition without Finger-Food Without Finger-Food: Without finger-food |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Exclusion of 4 patients from the intention-to-treat analysis (for whom at least one post-randomisation efficacy endpoint had been measured).
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| ID | Title | Description |
|---|---|---|
| BG000 | Nutrition With Finger-Food | Nutrition with Finger-Food Finger-Food: Finger-Food at lunch and having diner |
| BG001 | Nutrition Without Finger-Food | Nutrition without Finger-Food Without Finger-Food: Without finger-food |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quantitative Measure of Ingesta | Quantitative measure of ingesta (calorie and protein intake) | Posted | Mean | 95% Confidence Interval | Kilocalories | Monthly: From date of finger-food's implementation until the date of the end of the study (assessed up to 6 months) |
|
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Death, serious adverse event and other (non serious adverse event) were not assessed for the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nutrition With Finger-Food | Nutrition with Finger-Food Finger-Food: Finger-Food at lunch and having diner |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sylvie VERBRUGGHE | Centre Hospitalier Départemental Vendée | 0251446161 | sylvie.verbrugghe@ght85.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2017 | Oct 20, 2022 | Prot_SAP_000.pdf |
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| Without Finger-Food |
| Other |
Without finger-food |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
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|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Nutrition Without Finger-Food | Nutrition without Finger-Food Without Finger-Food: Without finger-food | 0 | 0 | 0 | 0 | 0 | 0 |
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