Complementary Feeding Clinical Trial
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.
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.
;
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