Nutritive ValueFIFONCT02925728
Nutritional Intake of "Finger-food" on Elderly People in Seniors's Resident
A study testing Finger-Food and Without Finger-Food in people with Nutritive Value, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nutritive Value
- What is being tested?
- Finger-Food and Without Finger-Food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2017to 25 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Confined to bed
- Specific diets (without residue, allergen, …)
- Enteral nutrition
- Absence motricity of 2 hands
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Nutritive Value
- Being tested
- Finger-Food, Without Finger-Food
- Keywords
- Finger-Food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finger-FoodOther
Finger-Food at lunch and having diner
Without Finger-FoodOther
Without finger-food
| Study group | Role | What they receive |
|---|---|---|
| Nutrition with Finger-Food | Experimental | Nutrition with Finger-Food Receives: Other: Finger-Food |
| Nutrition without Finger-Food | Active comparator | Nutrition without Finger-Food Receives: Other: Without Finger-Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Measure of Ingesta
Quantitative measure of ingesta (calorie and protein intake)
Measured: Monthly: From date of finger-food's implementation until the date of the end of the study (assessed up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start7 Feb 2017
- Primary completion25 Sep 2017
- Study completion25 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nutritive ValueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925728
- Sponsor's protocol ID
- CHD052-16
- Acronym
- FIFO
- Status last verified
- Mar 2024
- First submitted
- 27 Sep 2016
- Last updated
- 15 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intake of "Finger-food" on Elderly People in Seniors's Resident
- ClinicalTrials.gov ID
- NCT02925728
- Acronym / sponsor ID
- FIFO / CHD052-16
- Conditions
- Nutritive Value
- Keywords
- Finger-Food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 25 Sep 2017 (actual)
- Study completion
- 25 Sep 2017 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Posted 15 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition with Finger-Food | Experimental | Other: Finger-FoodNutrition with Finger-Food |
| Nutrition without Finger-Food | Active comparator | Other: Without Finger-FoodNutrition without Finger-Food |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- Confined to bed
- Specific diets (without residue, allergen, …)
- Enteral nutrition
- Absence motricity of 2 hands
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finger-FoodFinger-Food at lunch and having diner | Other | Nutrition with Finger-Food |
| Without Finger-FoodWithout finger-food | Other | Nutrition without Finger-Food |
Primary outcome
Quantitative Measure of Ingesta
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 (calorie and protein intake)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finger-Food and Without Finger-Food in people with Nutritive Value, run by Centre Hospitalier Departemental Vendee at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Measure of Ingesta (time frame: Monthly: From date of finger-food's implementation until the date of the end of the study (assessed up to 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.