WeaningDIVPEDNCT06839846
Survey of Different Modes of Weaning in Pediatric Population
An observational study of Weaning, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 4 sites in Italy.
Trial summary
Infant weaning refers to the transition from a diet based on the exclusive intake of milk (mother's milk or formula) to a diversified diet that is complete with all the nutrients necessary for proper infant development. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Weaning
- How many people
- 500 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Apr 2022to 30 Jun 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participation will be offered to all parents who reflect the inclusion criteria by specifying the observational nature of the study and the importance of deepening the prevalence and knowledge of the different diveating modes. It is specified that one of the two parents will be sufficient to complete the questionnaire. In the case of twins, the questionnaire will include completion of the weaning questions for each child. These persons will be recruited from the wards and waiting rooms of the Centers participating in the study without retaining any personal data of the enrolled subject. Access to the online questionnaire will be via access link that will be provided to the subjects via e-mail to the address they provide.
Who may be able to join
- Parents group:
- Overage parents with children between the ages of 4 and 18 months
- Need to have an electronic tool that allows direct access to the link connected to an internet network
- Understanding of the Italian language
- Obtaining informed consent from the parent completing the questionnaire
- Pediatricians group:
Show all 9Show fewer
- Activities of Free Choice Pediatrician in Italy.
- Need to have an electronic tool that allows direct access to the link connected to an Internet network
- Obtaining informed consent
Who cannot join
- Parents group:
- Parents of children with chronic neurological diseases, dysphagia, chronic diseases involving specific diet, intestinal diseases resulting in malabsorption;
- Pediatricians group:
- None
Trial locations and contacts
4 sites in 1 country.
Italy4 sites, 4 recruiting
- Recruiting
Ospedale Maggiore, Azienda USL di Bologna UO Pediatria
Bologna, 40133
Francesca Lombardi, MD, 051 647 8111, francesca.lombardi@ausl.bologna.it
Francesca Lombardi, MD
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria d'Urgenza, Pronto Soccorso e Osservazione Breve ed Intensiva
Bologna, 40138
Arianna Dondi, MD, 0512143012, arianna.dondi@aosp.bo.it
Arianna Dondi, MD
- Recruiting
Ospedale Ramazzini di Carpi, Azienda USL di Modena UO Pediatria
Carpi, Modena, 41012
Elisa Corinaldesi, MD, 0592025805, elcorinaldesi@yahoo.it
Elisa Corinaldesi, MD
- Recruiting
Ospedale S. Maria della Scaletta, Azienda USL di Imola UO Pediatria
Imola, Bologna, 40026
Paolo Bottau, 0542-662811, p.bottau@ausl.imola.bo.it
Paolo Bottau, MD
About this study
Infant weaning refers to the transition from a diet based on the exclusive intake of milk (mother's milk or formula) to a diversified diet that is complete with all the nutrients necessary for proper infant development. For this purpose, a diet supplementary to milk, which is gradually reduced, is undertaken in order to gradually acquire the dietary pattern followed by the family.
There are different types of weaning, which vary according to traditions, ethnicity and scientific currents. These include traditional weaning and on-demand self-weaning. The former consists of weaning with specific infant foods (example: freeze-dried, homogenized, vegetable broth, creams..) offered at set doses, quantities, and times. On the other hand, 'autodivezzamento on demand is a mode of weaning entrusted to the child's request, leaving the child to choose quantities and types of food, even prepared at home, during family meals. The aim of our study is to establish the prevalence of different modes of weaning and the perception of advantages and disadvantages related to them by parents and Free Choice Pediatricians by means of two different dedicated questionnaires. The study also aims to assess possible risks resulting from the transition to complementary feeding, for example, errors in feeding or inhalation of foreign bodies.
Read the detailed description
Infant weaning refers to the transition from a diet based solely on milk (breast milk or formula) to a diversified and complete diet, given by the presence of all foods introduced through complementary feeding.
The onset of weaning is influenced by several factors that contribute to the infant's autonomy, such as proper neuromotor development, development of taste and personal inclinations, maturation of kidney and gastrointestinal function, and social and socioeconomic factors.1 This gradual process can last from a few months to a couple of years.
There are different types of weaning, which vary according to traditions, ethnicity and scientific currents. These include traditional weaning or TSF, Baby-led Weaning (BLW) and Baby-led introduction to solids (BLISS).
TSF consists of the introduction of complementary feeding including solid or semisolid type foods served in the form of spoon puree and specially prepared foods for children with suggested doses, composition, quantities, and schedules.
BLW or autodiving refers to a type of complementary feeding introduction in which the infant can control the process from the beginning, setting the pace according to his or her appetite. The introduction of food is dictated by the infant's interest in food and his or her ability to self-feed small portions of food normally taken during family meals. For this purpose, the infant sits at the table with family members and takes food portions of a size and texture proportionate to his or her neurodevelopment and acquisition. The infant may feed independently with or without the aid of cutlery.
BLISS is a modified form of BLW that has implemented arrangements aimed at preventing foreign body inhalation. This modified version includes the start of weaning at the age of 6 months, coupled with general advice and rules specifically created to reduce the risk of choking. Pediatricians of free choice (PLS) play a key role in the implementation of weaning, in terms of providing advice on the different modes and food selection and preparation.
Benefits and risks related to different types of weaning BLW reduces the risk of eating disorders, facilitates the transition to the family diet, and incentivizes the family to follow a balanced diet.
This practice promotes the infant's adaptation to different food textures and tastes, speeds up learning to chew, development of fine motor skills, and overall maturation of the child, and is not correlated with poor infant staturo-ponderal growth. Although this approach has many advantages, a theoretical concern, relates to its safety and the possible increased risk of choking and inhalation from EC. There are conflicting data in the literature; some studies point to a likely reduction in the risk of choking due to an increase in gagging, which would lead to regurgitation of food rather than inhalation of food. In fact, BLW is an approach in which the infant tends to assume a more appropriate posture and is focused on actively chewing foods, unlike traditional weaning in which he or she receives, in a more relaxed position, foods served in pureed form that are directly swallowed without being chewed. So, according to some authors, traditional weaning would stimulate the infant's chewing ability less and increase the risk of inhalation compared with BLW. According to other authors, children following a BLISS-type weaning method accompanied by advice to minimize choking risks do not have a higher risk of inhalation than children following traditional weaning. This would show that the safety of TSF and BLISS may be comparable. In light of these observations, it is of particular interest to investigate this topic further given the absence of sufficient evidence in the literature that has clarified the relationship between these issues and weaning patterns.
- Conditions
- Weaning
- Keywords
- weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parents | the survey will be proposed to adult parents of children aged 4-18 months by means of a specific questionnaire dedicated to them. | |
| Pediatrician | another specific questionnaire intended for the Pediatrician will be proposed to PLSs who give their willingness. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate how parents and pediatricians implement weaning
- Percentage of parents choosing a particular weaning mode;
- reasons expressed by Pediatricians of Free Choice in suggesting their chosen weaning mode.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Different ways of weaning suggestionated by free choice Pediatricians
- Analysis of the different ways in which weaning is implemented in terms of food choice and meal delivery by parents and related suggestions by Free Choice Pediatricians;
- What risks associated with weaning are perceived by parents and Pediatricians of Free Choice.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Apr 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WeaningStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arianna Dondi, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839846
- Sponsor's protocol ID
- DIVPED
- Acronym
- DIVPED
- Status last verified
- Oct 2024
- First submitted
- 1 Dec 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- 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 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Different Modes of Weaning in Pediatric Population
- ClinicalTrials.gov ID
- NCT06839846
- Acronym / sponsor ID
- DIVPED / DIVPED
- Conditions
- Weaning
- Keywords
- weaning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 21 Feb 2025 (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.
Infant weaning refers to the transition from a diet based on the exclusive intake of milk (mother's milk or formula) to a diversified diet that is complete with all the nutrients necessary for proper infant development. For this purpose, a diet supplementary to milk, which is gradually reduced, is undertaken in order to gradually acquire the dietary pattern followed by the family.
There are different types of weaning, which vary according to traditions, ethnicity and scientific currents. These include traditional weaning and on-demand self-weaning. The former consists of weaning with specific infant foods (example: freeze-dried, homogenized, vegetable broth, creams..) offered at set doses, quantities, and times. On the other hand, 'autodivezzamento on demand is a mode of weaning entrusted to the child's request, leaving the child to choose quantities and types of food, even prepared at home, during family meals. The aim of our study is to establish the prevalence of different modes of weaning and the perception of advantages and disadvantages related to them by parents and Free Choice Pediatricians by means of two different dedicated questionnaires. The study also aims to assess possible risks resulting from the transition to complementary feeding, for example, errors in feeding or inhalation of foreign bodies.
Detailed description
Infant weaning refers to the transition from a diet based solely on milk (breast milk or formula) to a diversified and complete diet, given by the presence of all foods introduced through complementary feeding.
The onset of weaning is influenced by several factors that contribute to the infant's autonomy, such as proper neuromotor development, development of taste and personal inclinations, maturation of kidney and gastrointestinal function, and social and socioeconomic factors.1 This gradual process can last from a few months to a couple of years.
There are different types of weaning, which vary according to traditions, ethnicity and scientific currents. These include traditional weaning or TSF, Baby-led Weaning (BLW) and Baby-led introduction to solids (BLISS).
TSF consists of the introduction of complementary feeding including solid or semisolid type foods served in the form of spoon puree and specially prepared foods for children with suggested doses, composition, quantities, and schedules.
BLW or autodiving refers to a type of complementary feeding introduction in which the infant can control the process from the beginning, setting the pace according to his or her appetite. The introduction of food is dictated by the infant's interest in food and his or her ability to self-feed small portions of food normally taken during family meals. For this purpose, the infant sits at the table with family members and takes food portions of a size and texture proportionate to his or her neurodevelopment and acquisition. The infant may feed independently with or without the aid of cutlery.
BLISS is a modified form of BLW that has implemented arrangements aimed at preventing foreign body inhalation. This modified version includes the start of weaning at the age of 6 months, coupled with general advice and rules specifically created to reduce the risk of choking. Pediatricians of free choice (PLS) play a key role in the implementation of weaning, in terms of providing advice on the different modes and food selection and preparation.
Benefits and risks related to different types of weaning BLW reduces the risk of eating disorders, facilitates the transition to the family diet, and incentivizes the family to follow a balanced diet.
This practice promotes the infant's adaptation to different food textures and tastes, speeds up learning to chew, development of fine motor skills, and overall maturation of the child, and is not correlated with poor infant staturo-ponderal growth. Although this approach has many advantages, a theoretical concern, relates to its safety and the possible increased risk of choking and inhalation from EC. There are conflicting data in the literature; some studies point to a likely reduction in the risk of choking due to an increase in gagging, which would lead to regurgitation of food rather than inhalation of food. In fact, BLW is an approach in which the infant tends to assume a more appropriate posture and is focused on actively chewing foods, unlike traditional weaning in which he or she receives, in a more relaxed position, foods served in pureed form that are directly swallowed without being chewed. So, according to some authors, traditional weaning would stimulate the infant's chewing ability less and increase the risk of inhalation compared with BLW. According to other authors, children following a BLISS-type weaning method accompanied by advice to minimize choking risks do not have a higher risk of inhalation than children following traditional weaning. This would show that the safety of TSF and BLISS may be comparable. In light of these observations, it is of particular interest to investigate this topic further given the absence of sufficient evidence in the literature that has clarified the relationship between these issues and weaning patterns.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents | – | –the survey will be proposed to adult parents of children aged 4-18 months by means of a specific questionnaire dedicated to them. |
| Pediatrician | – | –another specific questionnaire intended for the Pediatrician will be proposed to PLSs who give their willingness. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participation will be offered to all parents who reflect the inclusion criteria by specifying the observational nature of the study and the importance of deepening the prevalence and knowledge of the different diveating modes. It is specified that one of the two parents will be sufficient to complete the questionnaire. In the case of twins, the questionnaire will include completion of the weaning questions for each child. These persons will be recruited from the wards and waiting rooms of the Centers participating in the study without retaining any personal data of the enrolled subject. Access to the online questionnaire will be via access link that will be provided to the subjects via e-mail to the address they provide.
Key inclusion criteria (9 listed)
- Overage parents with children between the ages of 4 and 18 months
- Need to have an electronic tool that allows direct access to the link connected to an internet network
- Understanding of the Italian language
- Obtaining informed consent from the parent completing the questionnaire
- Activities of Free Choice Pediatrician in Italy.
Key exclusion criteria (4 listed)
- Parents of children with chronic neurological diseases, dysphagia, chronic diseases involving specific diet, intestinal diseases resulting in malabsorption;
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate how parents and pediatricians implement weaning
Time frame: through study completion, an average of 1 year
* Percentage of parents choosing a particular weaning mode; * reasons expressed by Pediatricians of Free Choice in suggesting their chosen weaning mode.
1 secondary outcome
Different ways of weaning suggestionated by free choice Pediatricians
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
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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.
Arianna Dondi, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weaning, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 4 sites in Italy.
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 9 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: status not confirmed, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arianna Dondi, MD (0512143012, arianna.dondi@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate how parents and pediatricians implement weaning (time frame: through study completion, an average of 1 year). 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 21 Feb 2025.