Malnutrition of Mild DegreeAlimAgeNCT03269500
Evaluation of the Applicability of Personalized Tools About Nutrition Education for Malnourished Older People
An observational study of Malnutrition of Mild Degree, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Describe the frequency of use of nutrition education tools for undernourished older people Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Malnutrition of Mild Degree
- What is being tested?
- use of nutrition education tools
- Type of treatment
- Pill or oral medicine
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2017to 7 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: malnourished elderly present on hospital day care
Who may be able to join
- Subject of 75 years or more.
- Hospitalized geriatric day hospital.
- Living at home, within a radius of 40 km around the hospital Xavier Arnozan.
- Subject or caregiver (s) read, understand and speak the french.
- Undernutrition (criteria of the French high authority for health (HAS) 2007)
- Agreed to participate in the study: compendium of the opposition
Who cannot join
- Subject not wishing to participate in the study,
- MMSE (Mini Mental State Examination) < 20, without presence of a caregiver with no cognitive problems scoring.
- Identified palliative care.
- Presenting a contraindication to oral feeding.
- Presence of supply of enteral or parenteral.
- Presence with a diagnosis of severe psychiatric pathology.
- Already participating in a study on undernutrition.
- One against medical advice.
Trial locations and contacts
1 site in 1 country.
About this study
Describe the frequency of use of nutrition education tools for undernourished older people
Read the detailed description
The description of the population will identify the characteristics of patients who use the tools and guide their use in patient care. To realize an impact assessment, It necessary to identify specific criteria for inclusion. It is important initially to assess the use of the nutritional tools. The assessment of performance (obstacles and understanding), will be used to improve tools to optimize their use.
- Conditions
- Malnutrition of Mild Degree
- Being tested
- use of nutrition education tools
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of nutrition education toolsOther
Use of different nutrition education tools :
- General advice: feeding seniors
- Oral supplementation: instructions for use
- Information about enriched food
- Food modified in texture: chopped masticatory disorders, chopped swallowing disorders, co-mingled
- How should I drink? : With stimulus, texture syrup / nectar, velvety texture, texture compote / cream
- Recipe booklets for people to easily eat (chewing disorders) or recipe with molded texture (swallowing disorders)
| Study group | Role | What they receive |
|---|---|---|
| malnourished older people | The hospitalized elderly with swallowing and/or Mastication problems. Receives: Other: use of nutrition education tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of use of the booklet and platelets
number of use per week
Measured: Day 14
Secondary outcomes (3)
Evaluation of the knowledge following the delivery of the tools
Number of response "Yes" for 24 items about the tools
Measured: Day 14
Instrumental Activities of Daily Living
Score of Instrumental Activities of Daily Living
Measured: Day 1
Assessment of quality of life scale
Score of EQ-5D
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start5 Sep 2017
- Primary completion7 Aug 2018
- Study completion7 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition of Mild DegreeStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ornella SARRY, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269500
- Sponsor's protocol ID
- CHUBX 2016/51
- Acronym
- AlimAge
- Status last verified
- May 2022
- First submitted
- 28 Aug 2017
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Applicability of Personalized Tools About Nutrition Education for Malnourished Older People
- ClinicalTrials.gov ID
- NCT03269500
- Acronym / sponsor ID
- AlimAge / CHUBX 2016/51
- Conditions
- Malnutrition of Mild Degree
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 7 Aug 2018 (actual)
- Study completion
- 7 Aug 2018 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Describe the frequency of use of nutrition education tools for undernourished older people
Detailed description
The description of the population will identify the characteristics of patients who use the tools and guide their use in patient care. To realize an impact assessment, It necessary to identify specific criteria for inclusion. It is important initially to assess the use of the nutritional tools. The assessment of performance (obstacles and understanding), will be used to improve tools to optimize their use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| malnourished older people | – | Other: use of nutrition education toolsThe hospitalized elderly with swallowing and/or Mastication problems. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- malnourished elderly present on hospital day care
Key inclusion criteria (6 listed)
- Subject of 75 years or more.
- Hospitalized geriatric day hospital.
- Living at home, within a radius of 40 km around the hospital Xavier Arnozan.
- Subject or caregiver (s) read, understand and speak the french.
- Undernutrition (criteria of the French high authority for health (HAS) 2007)
Key exclusion criteria (8 listed)
- Subject not wishing to participate in the study,
- MMSE (Mini Mental State Examination) < 20, without presence of a caregiver with no cognitive problems scoring.
- Identified palliative care.
- Presenting a contraindication to oral feeding.
- Presence of supply of enteral or parenteral.
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 |
|---|---|---|
| use of nutrition education toolsUse of different nutrition education tools : * General advice: feeding seniors * Oral supplementation: instructions for use * Information about enriched food * Food modified in texture: chopped masticatory disorders, chopped swallowing disorders, co-mingled * How should I drink? : With stimulus, texture syrup / nectar, velvety texture, texture compote / cream * Recipe booklets for people to easily eat (chewing disorders) or recipe with molded texture (swallowing disorders) | Other | malnourished older people |
Primary outcome
Frequency of use of the booklet and platelets
Time frame: Day 14
number of use per week
3 secondary outcomes
Evaluation of the knowledge following the delivery of the tools
Time frame: Day 14
Instrumental Activities of Daily Living
Time frame: Day 1
Assessment of quality of life scale
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: No
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.
Ornella SARRY principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition of Mild Degree, run by University Hospital, Bordeaux 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 6 inclusion and 8 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 13 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of use of the booklet and platelets (time frame: Day 14). 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 13 May 2022.