Nutritive Value
Conditions
Keywords
Finger-Food
Brief summary
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.
Interventions
OTHERFinger-Food
Finger-Food at lunch and having diner
OTHERWithout Finger-Food
Without finger-food
Sponsors
Centre Hospitalier Departemental Vendee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Residents institutionalized in seniors's resident for 3 months at least * Residents in disability to feed single-handedly because of cognitive and/or physical disorders * Having at least use of a hand * Do not opposing the participation in the study or information and not opposition of the family / close to confidence / legal guardian in case of resident in incapacity to understand (senility, insanity)
Exclusion criteria
* Confined to bed * Specific diets (without residue, allergen, …) * Enteral nutrition * Absence motricity of 2 hands
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Measure of Ingesta | Monthly: From date of finger-food's implementation until the date of the end of the study (assessed up to 6 months) | Quantitative measure of ingesta (calorie and protein intake) |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nutrition With Finger-Food Nutrition with Finger-Food
Finger-Food: Finger-Food at lunch and having diner | 20 |
| Nutrition Without Finger-Food Nutrition without Finger-Food
Without Finger-Food: Without finger-food | 23 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 5 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Nutrition With Finger-Food | Total | Nutrition Without Finger-Food |
|---|---|---|---|
| Age, Continuous | 85.3 Years STANDARD_DEVIATION 8.6 | 83.7 Years STANDARD_DEVIATION 8.2 | 82.3 Years STANDARD_DEVIATION 7.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants | 43 Participants | 23 Participants |
| Sex: Female, Male Female | 15 Participants | 31 Participants | 16 Participants |
| Sex: Female, Male Male | 5 Participants | 12 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Quantitative Measure of Ingesta
Quantitative measure of ingesta (calorie and protein intake)
Time frame: Monthly: From date of finger-food's implementation until the date of the end of the study (assessed up to 6 months)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Nutrition With Finger-Food | Quantitative Measure of Ingesta | M2 | 984 Kilocalories |
| Nutrition With Finger-Food | Quantitative Measure of Ingesta | M4 | 1065 Kilocalories |
| Nutrition With Finger-Food | Quantitative Measure of Ingesta | M1 | 1001 Kilocalories |
| Nutrition With Finger-Food | Quantitative Measure of Ingesta | M5 | 1055 Kilocalories |
| Nutrition With Finger-Food | Quantitative Measure of Ingesta | M3 | 1073 Kilocalories |
| Nutrition With Finger-Food | Quantitative Measure of Ingesta | M6 | 1051 Kilocalories |
| Nutrition With Finger-Food | Quantitative Measure of Ingesta | M-1 | 941.1 Kilocalories |
| Nutrition Without Finger-Food | Quantitative Measure of Ingesta | M6 | 647.6 Kilocalories |
| Nutrition Without Finger-Food | Quantitative Measure of Ingesta | M-1 | 910.1 Kilocalories |
| Nutrition Without Finger-Food | Quantitative Measure of Ingesta | M1 | 862.9 Kilocalories |
| Nutrition Without Finger-Food | Quantitative Measure of Ingesta | M2 | 843.4 Kilocalories |
| Nutrition Without Finger-Food | Quantitative Measure of Ingesta | M3 | 865.1 Kilocalories |
| Nutrition Without Finger-Food | Quantitative Measure of Ingesta | M4 | 971.9 Kilocalories |
| Nutrition Without Finger-Food | Quantitative Measure of Ingesta | M5 | 765.9 Kilocalories |
p-value: <0.0001Mixed Models Analysis