Nutritional Intake of "Finger-food" on Elderly People in Seniors's Resident (FIFO)

October 31, 2017 updated by: Centre Hospitalier Departemental Vendee

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Roche sur Yon, France, 85925
        • Centre Hospitalier Départemental Vendée

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutrition with Finger-Food
Other: Finger-Food
Finger-Food at lunch and having diner
Active Comparator: Nutrition without Finger-Food
Other: Without Finger-Food
Without finger-food

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative measure of ingesta in grams
Time Frame: 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 in grams
Monthly: From date of finger-food's implementation until the date of the end of the study (assessed up to 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2017

Primary Completion (Actual)

September 25, 2017

Study Completion (Actual)

September 25, 2017

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 31, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHD052-16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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