Infant Nutritional Physiological PhenomenaNCT03675607
Preparation of Complementary Feeding in Spain: a Cross-sectional Study
An observational study of Infant Nutritional Physiological Phenomena and Complementary Feeding, run by Academia Española de Nutrición y Dietética at 1 site in Spain.
Trial summary
Study design: Cross-sectional study, survey based Study population: spanish people, caregivers of infants under 2 years old. Sample size: 1925 surveys. Study duration and research process: 10 days on-line survey that will be opened through a launching page. The survey is composed of 3 blocks. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infant Nutritional Physiological Phenomena, Complementary Feeding
- What is being tested?
- Complementary feeding behaviours
- How many people
- 1,925 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2018to 1 Jun 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Spanish people included in a Spanish private database (Netquest Iberia, more than 100,000 available panelists), constituted as a closed panel of caregivers of infants <2years old who prepare at least complementary feeding twice a week (actual or in the past). The panel of participants has the ISO 26362 certification, which represents the level of quality contrasted in methods of recruitment, panelization, treatment of the panelist and the data. In order to broaden the geographical diversity of the participants, and based on the characteristics of the panel used, the objective is to reach the maximum number of possible surveys in the observation period of the appropriate panelists (1,925 surveys in 10 days).
Who may be able to join
- people included in a Spanish private database (Netquest Iberia
- caregivers of infants <2years old who prepare at least complementary feeding twice a week (actual or in the past)
- any texture/type of complementary feeding (blended/beikost/solid)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Knowledge and Habitual Practices in the Preparation of Complementary Feeding in Spain a: Cross-sectional Study
Study design: Cross-sectional study, survey based
Study population: spanish people, caregivers of infants under 2 years old. Sample size: 1925 surveys.
Study duration and research process: 10 days on-line survey that will be opened through a launching page. The survey is composed of 3 blocks.
Statistical analysis: data will be analyzed using the Statistical Analysis System (SAS) package version 9.4 (or higher). The categorical variables will be presented in the form of lists of frequencies and percentages. For the quantitative variables (continuous or ordinal), indices of central tendency (mean, median) and dispersion (standard deviation and maximum and minimum values) will also be presented.
Read the detailed description
Study design: cross-sectional study, survey to collect data about knowledge, opinions, attitudes or behaviors of the Spanish population in relation to the preparation of complementary feeding for children.
Study population: self-reported information will be collected from a sample of Spanish population. The participants will be people included in a Spanish private database (Netquest Iberia, more than 100,000 available panelists). This database is constituted as a closed panel, from which the participants are invited individually to carry out a survey, and are selected according to their characteristics and ideal representativeness for the purpose of the evaluation. The panel of participants has the International Organization for Standardization (ISO) 26362 certification, which represents the level of quality contrasted in methods of recruitment, and treatment of the panelist and the data. To reach the objective of this study, the calculation of the minimum representative sample of the Spanish population corresponds to the completion of 385 surveys in the national territory. However, in order to broaden the geographical diversity of the participants, and based on the characteristics of the panel used, the objective is to reach the maximum number of possible surveys in the observation period of the appropriate panelists (1,925 surveys in 10 days).
Duration of the study: the study begins once the on-line survey is made available to the participants. The survey is expected to be available for a period of 10 days.
Subsequently, the corresponding database will be closed and the results will be exploited. The total duration of the study, until the publication of objective results, is established in 6 months.
Research process: For the realization of this on-line survey, a closed database of 100,000 panelists will be used, from which the ideal profile of the participants will be selected and a personalized invitation will be issued for their participation.
Once the invitation to the candidates to participate has been issued, a period of availability of the 10-day on-line survey will be opened through a web portal. Each participant will enter said portal individually, through a unique, personalized and anonymous access code. Once the survey has been activated for a specific participant, and after a brief introductory information, the sociodemographic data will be requested to be tabulated in order to tabulate the overall results of the survey (Annex 1: BLOCK 1). After the completion of BLOCK 1, all participants will start BLOCK 2, in which, for those participants who indicate that they prepare complementary food based on "mainly shredded", they will be asked a discriminatory question (Do you prepare or have you elaborated porridges? If you answer negatively to this question, the participant will be directed to the information collection block (BLOCK 3), since it is not pertinent to assess their practice and opinion. However, the fact of having children or their age is not considered discriminatory for the completion of the entire survey, given that the opinion and methodology of people who by profession can prepare homemade porridges, even without children, (eg nursery workers), as well as the opinion of those who currently have no small children (eg over 50 years old) ), remains of interest for the main objective of the study. The data or sections corresponding to BLOCK 2 and BLOCK 3 are presented in Annexes 2 and 3, respectively. Participants can complete the survey sequentially, even from different terminals, always with the same access code. Once all the corresponding sections have been completed, the participant will validate the answers and confirm their final submission, at which time the data will be compiled in the global database corresponding to the collection of the information of all the completed surveys. At the end of the period of completing forms, the database will be closed and statistics will be exploited in order to obtain objective results.
Statistical analysis: the data will be analyzed using the statistical package SAS System version 9.4 (or higher). A descriptive statistic of all the variables collected will be made by completing the data collection form. The categorical variables will be presented in the form of lists of frequencies and percentages. For the quantitative variables (continuous or ordinal), indices of central tendency (mean, median) and dispersion (standard deviation and maximum and minimum values) will also be presented.
- Being tested
- Complementary feeding behaviours
- Keywords
- Infant Nutritional Physiological Phenomena, Complementary feeding, Feeding Behavior, Food Preferences, Parenting, Health Knowledge, Attitudes, Practice
- Medical subject headings
- Feeding Behavior, Food Preferences, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complementary feeding behavioursOther
Also called beikost use, baby-led weaning
Any kind of complementary feeding practice
| Study group | Role | What they receive |
|---|---|---|
| Caregivers infants <2years old | Caregivers of infants under 2 years of age (parents or other), of any gender, who prepare complementary feeding regularly (more than once a week). Receives: Other: Complementary feeding behaviours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Texture/type of complementary feeding (dichotomic)
Know how caregivers prepare the complementary feeding, mainly blended or solid
Measured: 1 month
Ingredient selection (%)
know how caregivers select ingredients to allow diversity
Measured: 1 month
Food/ingredient amount (gr/100gr)
know the amount of food and ingredients are often used by caregivers
Measured: 1 month
Ingredient preparation and cooking technique
know the ingredient preparation and cooking technique usually used by careguivers
Measured: 1 month
Secondary outcomes (3)
conservation technique
know what conservation techniques are used by caregivers
Measured: 1 month
hygiene
mainly hand/ingrediente washing behaviours
Measured: 1 month
Wold Health Organization (WHO) core indicators about complementary feeding
Wold Health Organization (WHO) core indicators about complementary feeding
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 May 2018
- Primary completion20 May 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Nutritional Physiological PhenomenaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,925 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academia Española de Nutrición y Dietética
- Sponsor type
- University, hospital or other
- Collaborators
- LIDL España
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675607
- Sponsor's protocol ID
- LIDL-PPIC-2018
- Status last verified
- Jun 2018
- First submitted
- 11 Jun 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge and Habitual Practices in the Preparation of Complementary Feeding in Spain a: Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03675607
- Acronym / sponsor ID
- LIDL-PPIC-2018
- Keywords
- Infant Nutritional Physiological Phenomena, Complementary feeding, Feeding Behavior, Food Preferences, Parenting, Health Knowledge, Attitudes, Practice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,925 participants (actual)
- Lead sponsor
- Academia Española de Nutrición y DietéticaUniversity, hospital or other
- Collaborators
- LIDL España
- Study start
- 1 May 2018 (actual)
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 18 Sep 2018 (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.
Study design: Cross-sectional study, survey based
Study population: spanish people, caregivers of infants under 2 years old. Sample size: 1925 surveys.
Study duration and research process: 10 days on-line survey that will be opened through a launching page. The survey is composed of 3 blocks.
Statistical analysis: data will be analyzed using the Statistical Analysis System (SAS) package version 9.4 (or higher). The categorical variables will be presented in the form of lists of frequencies and percentages. For the quantitative variables (continuous or ordinal), indices of central tendency (mean, median) and dispersion (standard deviation and maximum and minimum values) will also be presented.
Detailed description
Study design: cross-sectional study, survey to collect data about knowledge, opinions, attitudes or behaviors of the Spanish population in relation to the preparation of complementary feeding for children.
Study population: self-reported information will be collected from a sample of Spanish population. The participants will be people included in a Spanish private database (Netquest Iberia, more than 100,000 available panelists). This database is constituted as a closed panel, from which the participants are invited individually to carry out a survey, and are selected according to their characteristics and ideal representativeness for the purpose of the evaluation. The panel of participants has the International Organization for Standardization (ISO) 26362 certification, which represents the level of quality contrasted in methods of recruitment, and treatment of the panelist and the data. To reach the objective of this study, the calculation of the minimum representative sample of the Spanish population corresponds to the completion of 385 surveys in the national territory. However, in order to broaden the geographical diversity of the participants, and based on the characteristics of the panel used, the objective is to reach the maximum number of possible surveys in the observation period of the appropriate panelists (1,925 surveys in 10 days).
Duration of the study: the study begins once the on-line survey is made available to the participants. The survey is expected to be available for a period of 10 days.
Subsequently, the corresponding database will be closed and the results will be exploited. The total duration of the study, until the publication of objective results, is established in 6 months.
Research process: For the realization of this on-line survey, a closed database of 100,000 panelists will be used, from which the ideal profile of the participants will be selected and a personalized invitation will be issued for their participation.
Once the invitation to the candidates to participate has been issued, a period of availability of the 10-day on-line survey will be opened through a web portal. Each participant will enter said portal individually, through a unique, personalized and anonymous access code. Once the survey has been activated for a specific participant, and after a brief introductory information, the sociodemographic data will be requested to be tabulated in order to tabulate the overall results of the survey (Annex 1: BLOCK 1). After the completion of BLOCK 1, all participants will start BLOCK 2, in which, for those participants who indicate that they prepare complementary food based on "mainly shredded", they will be asked a discriminatory question (Do you prepare or have you elaborated porridges? If you answer negatively to this question, the participant will be directed to the information collection block (BLOCK 3), since it is not pertinent to assess their practice and opinion. However, the fact of having children or their age is not considered discriminatory for the completion of the entire survey, given that the opinion and methodology of people who by profession can prepare homemade porridges, even without children, (eg nursery workers), as well as the opinion of those who currently have no small children (eg over 50 years old) ), remains of interest for the main objective of the study. The data or sections corresponding to BLOCK 2 and BLOCK 3 are presented in Annexes 2 and 3, respectively. Participants can complete the survey sequentially, even from different terminals, always with the same access code. Once all the corresponding sections have been completed, the participant will validate the answers and confirm their final submission, at which time the data will be compiled in the global database corresponding to the collection of the information of all the completed surveys. At the end of the period of completing forms, the database will be closed and statistics will be exploited in order to obtain objective results.
Statistical analysis: the data will be analyzed using the statistical package SAS System version 9.4 (or higher). A descriptive statistic of all the variables collected will be made by completing the data collection form. The categorical variables will be presented in the form of lists of frequencies and percentages. For the quantitative variables (continuous or ordinal), indices of central tendency (mean, median) and dispersion (standard deviation and maximum and minimum values) will also be presented.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers infants <2years old | – | Other: Complementary feeding behavioursCaregivers of infants under 2 years of age (parents or other), of any gender, who prepare complementary feeding regularly (more than once a week). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Spanish people included in a Spanish private database (Netquest Iberia, more than 100,000 available panelists), constituted as a closed panel of caregivers of infants <2years old who prepare at least complementary feeding twice a week (actual or in the past). The panel of participants has the ISO 26362 certification, which represents the level of quality contrasted in methods of recruitment, panelization, treatment of the panelist and the data. In order to broaden the geographical diversity of the participants, and based on the characteristics of the panel used, the objective is to reach the maximum number of possible surveys in the observation period of the appropriate panelists (1,925 surveys in 10 days).
Key inclusion criteria (3 listed)
- people included in a Spanish private database (Netquest Iberia
- caregivers of infants <2years old who prepare at least complementary feeding twice a week (actual or in the past)
- any texture/type of complementary feeding (blended/beikost/solid)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Complementary feeding behavioursAlso: beikost use, baby-led weaningAny kind of complementary feeding practice | Other | Caregivers infants <2years old |
Primary outcome
Texture/type of complementary feeding (dichotomic)
Time frame: 1 month
Know how caregivers prepare the complementary feeding, mainly blended or solid
Ingredient selection (%)
Time frame: 1 month
know how caregivers select ingredients to allow diversity
Food/ingredient amount (gr/100gr)
Time frame: 1 month
know the amount of food and ingredients are often used by caregivers
Ingredient preparation and cooking technique
Time frame: 1 month
know the ingredient preparation and cooking technique usually used by careguivers
3 secondary outcomes
conservation technique
Time frame: 1 month
hygiene
Time frame: 1 month
Wold Health Organization (WHO) core indicators about complementary feeding
Time frame: 1 month
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 18 Sep 2018.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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?
An observational study of Infant Nutritional Physiological Phenomena and Complementary Feeding, run by Academia Española de Nutrición y Dietética at 1 site in Spain.
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 3 inclusion and 0 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 18 Sep 2018. 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 Spain. 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?
Texture/type of complementary feeding (dichotomic) (time frame: 1 month). The study lists 4 primary outcomes in all. 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 18 Sep 2018.