NCT02925728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

February 7, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2017

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

August 15, 2024

Completed
Last Updated

August 15, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

September 27, 2016

Results QC Date

October 21, 2022

Last Update Submit

March 15, 2024

Conditions

Keywords

Finger-Food

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Nutrition with Finger-Food

EXPERIMENTAL

Nutrition with Finger-Food

Other: Finger-Food

Nutrition without Finger-Food

ACTIVE COMPARATOR

Nutrition without Finger-Food

Other: Without Finger-Food

Interventions

Finger-Food at lunch and having diner

Nutrition with Finger-Food

Without finger-food

Nutrition without Finger-Food

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Confined to bed
  • Specific diets (without residue, allergen, …)
  • Enteral nutrition
  • Absence motricity of 2 hands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Departemental Vendée

La Roche-sur-Yon, 85925, France

Location

Results Point of Contact

Title
Sylvie VERBRUGGHE
Organization
Centre Hospitalier Départemental Vendée

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

October 6, 2016

Study Start

February 7, 2017

Primary Completion

September 25, 2017

Study Completion

September 25, 2017

Last Updated

August 15, 2024

Results First Posted

August 15, 2024

Record last verified: 2024-03

Locations