NCT03675607

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,925

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2018

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
Last Updated

September 18, 2018

Status Verified

June 1, 2018

Enrollment Period

19 days

First QC Date

June 11, 2018

Last Update Submit

September 17, 2018

Conditions

Keywords

Infant Nutritional Physiological PhenomenaComplementary feedingFeeding BehaviorFood PreferencesParentingHealth Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (4)

  • Texture/type of complementary feeding (dichotomic)

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

    1 month

  • Ingredient selection (%)

    know how caregivers select ingredients to allow diversity

    1 month

  • Food/ingredient amount (gr/100gr)

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

    1 month

  • Ingredient preparation and cooking technique

    know the ingredient preparation and cooking technique usually used by careguivers

    1 month

Secondary Outcomes (3)

  • conservation technique

    1 month

  • hygiene

    1 month

  • Wold Health Organization (WHO) core indicators about complementary feeding

    1 month

Study Arms (1)

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).

Other: Complementary feeding behaviours

Interventions

Any kind of complementary feeding practice

Also known as: beikost use, baby-led weaning
Caregivers infants <2years old

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academia Española de Nutrición y Dietética

Pamplona, Navarre, 31006, Spain

Location

MeSH Terms

Conditions

Feeding BehaviorFood PreferencesBehavior

Condition Hierarchy (Ancestors)

Behavior, Animal

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2018

First Posted

September 18, 2018

Study Start

May 1, 2018

Primary Completion

May 20, 2018

Study Completion

June 1, 2018

Last Updated

September 18, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
within 6 months study completion

Locations