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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Spain1 site
  • Academia Española de Nutrición y Dietética

    Pamplona, Navarre, 31006

Other trials in Spain

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 groups in NCT03675607
Study groupRoleWhat they receive
Caregivers infants <2years oldCaregivers 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.

  1. Texture/type of complementary feeding (dichotomic)

    Know how caregivers prepare the complementary feeding, mainly blended or solid

    Measured: 1 month

  2. Ingredient selection (%)

    know how caregivers select ingredients to allow diversity

    Measured: 1 month

  3. Food/ingredient amount (gr/100gr)

    know the amount of food and ingredients are often used by caregivers

    Measured: 1 month

  4. Ingredient preparation and cooking technique

    know the ingredient preparation and cooking technique usually used by careguivers

    Measured: 1 month

Secondary outcomes (3)
  1. conservation technique

    know what conservation techniques are used by caregivers

    Measured: 1 month

  2. hygiene

    mainly hand/ingrediente washing behaviours

    Measured: 1 month

  3. 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.

  1. First posted18 Sep 2018
  2. Study start1 May 2018
  3. Primary completion20 May 2018
  4. Study completion1 Jun 2018

Resources

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)
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.

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.

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