Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT06996418
Eligibility Criteria:
Inclusion Criteria (older people):
* Informed consent signed by each participant or his/her legal representative.
* Eating autonomy: Ability to feed oneself without continuous assistance from another person.
* Expected stay at the Intergenerational Center until July 2025.
* Negative certificate of Sexual Offenses (mandatory in case of contact with minors).
* Screening for nutritional risk, dysphagia and oral health: Exclusion of persons with severe untreated malnutrition, severe dysphagia or oral problems preventing chewing.
* Adequate cognitive status: mild or moderate cognitive impairment (rating ≤5 on the Global Deterioration Scale - GDS).
Inclusion Criteria (toddlers):
* Informed consent: Signature of the legal guardian authorizing participation in the study.
* Child's assent: Positive expression of willingness to participate.
* Feeding autonomy: Ability to eat without continuous assistance from an adult.
* Expected permanence in the Intergenerational Center until July 2025.
Exclusion Criteria (older adults):
* Advanced cognitive impairment (GDS \> 5) affecting comprehension and social interaction.
* Severe dysphagia or oral health problems preventing normal feeding.
* Unstable medical conditions that limit intergenerational dining attendance.
* History of aggressive behavior or history of refusal to interact with children.
* Lack of consent or refusal to participate in any of the study assessments.
Exclusion Criteria (toddlers):
* Need for ongoing feeding assistance.
* Severe medical conditions affecting feeding or social participation (e.g. severe metabolic disease).
* Expectation of transfer or departure from the Intergenerational Center prior to completion of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT06996418
Study Brief:
Protocol Section:
NCT06996418