Trial Outcomes & Findings for Nutritional Intake of "Finger-food" on Elderly People in Seniors's Resident (NCT NCT02925728)
NCT ID: NCT02925728
Last Updated: 2024-08-15
Results Overview
Quantitative measure of ingesta (calorie and protein intake)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
Monthly: From date of finger-food's implementation until the date of the end of the study (assessed up to 6 months)
Results posted on
2024-08-15
Participant Flow
Participant milestones
| Measure |
Nutrition With Finger-Food
Nutrition with Finger-Food
Finger-Food: Finger-Food at lunch and having diner
|
Nutrition Without Finger-Food
Nutrition without Finger-Food
Without Finger-Food: Without finger-food
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
25
|
|
Overall Study
COMPLETED
|
17
|
20
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Nutrition With Finger-Food
Nutrition with Finger-Food
Finger-Food: Finger-Food at lunch and having diner
|
Nutrition Without Finger-Food
Nutrition without Finger-Food
Without Finger-Food: Without finger-food
|
|---|---|---|
|
Overall Study
Death
|
3
|
5
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Nutritional Intake of "Finger-food" on Elderly People in Seniors's Resident
Baseline characteristics by cohort
| Measure |
Nutrition With Finger-Food
n=20 Participants
Nutrition with Finger-Food
Finger-Food: Finger-Food at lunch and having diner
|
Nutrition Without Finger-Food
n=23 Participants
Nutrition without Finger-Food
Without Finger-Food: Without finger-food
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
85.3 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
82.3 Years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
83.7 Years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Nutrition With Finger-Food
n=20 Participants
Nutrition with Finger-Food
Finger-Food: Finger-Food at lunch and having diner
|
Nutrition Without Finger-Food
n=23 Participants
Nutrition without Finger-Food
Without Finger-Food: Without finger-food
|
|---|---|---|
|
Quantitative Measure of Ingesta
M4
|
1065 Kilocalories
Interval 917.1 to 1212.0
|
971.9 Kilocalories
Interval 776.7 to 1167.0
|
|
Quantitative Measure of Ingesta
M-1
|
941.1 Kilocalories
Interval 796.5 to 1086.0
|
910.1 Kilocalories
Interval 759.8 to 1060.0
|
|
Quantitative Measure of Ingesta
M1
|
1001 Kilocalories
Interval 858.8 to 1143.0
|
862.9 Kilocalories
Interval 712.6 to 1013.0
|
|
Quantitative Measure of Ingesta
M2
|
984 Kilocalories
Interval 839.5 to 1129.0
|
843.4 Kilocalories
Interval 673.4 to 1013.0
|
|
Quantitative Measure of Ingesta
M3
|
1073 Kilocalories
Interval 925.1 to 1220.0
|
865.1 Kilocalories
Interval 684.0 to 1046.0
|
|
Quantitative Measure of Ingesta
M5
|
1055 Kilocalories
Interval 907.4 to 1202.0
|
765.9 Kilocalories
Interval 551.4 to 980.5
|
|
Quantitative Measure of Ingesta
M6
|
1051 Kilocalories
Interval 900.3 to 1202.0
|
647.6 Kilocalories
Interval 366.0 to 929.2
|
Adverse Events
Nutrition With Finger-Food
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nutrition Without Finger-Food
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sylvie VERBRUGGHE
Centre Hospitalier Départemental Vendée
Phone: 0251446161
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place