Infant Nutrition in Austria (Sukie)

September 1, 2020 updated by: Karin Schindler

Breastfeeding Behavior, Infant and Child Nutrition in Austria

This study will give an update on the breastfeeding prevalence and infant nutrition in Austria.

Key aspects for this study are:

  1. the current breastfeeding rates
  2. further insights on factors influencing breastfeeding such as the information mothers have about breastfeeding, their attitude, support they received for breastfeeding problems as well as sociodemographic factors and
  3. complimentary feeding. All postpartum women in Austria were eligible for participation. It consists of representative and prospective data recordings of breastfeeding and infant nutrition for the participating mother-child pairs via online questionnaires at four times of measurement over a period of one year.

The results of the present study will give us an update about the development of breastfeeding rates in Austria and a better understanding of entry points for interventions on child nutrition and child health.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1666

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Medical University of Vienna, Vienna General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Mothers who have given birth within a defined period and are aged 18 years or above.

Description

Inclusion Criteria:

  • Mothers who gave birth during the recruitment period
  • Mothers older than 18 years

Exclusion Criteria:

  • Teenage-mothers
  • Mothers of newborns in intensive care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of breastfeeding after birth
Time Frame: Online questionnaire at 14 days postpartum (time of measurement 1)
Proportion of mothers initiating breastfeeding: assessing the breastfeeding prevalence after birth (% of participating mothers).
Online questionnaire at 14 days postpartum (time of measurement 1)
Prevalence of breastfeeding
Time Frame: Online questionnaire at 14 days postpartum (time of measurement 1)
Assessing the breastfeeding prevalence at 14 days postpartum (% of participating mothers)
Online questionnaire at 14 days postpartum (time of measurement 1)
Prevalence of breastfeeding
Time Frame: Online questionnaire at 4 months postpartum (time of measurement 2)
Assessing the breastfeeding prevalence at 4 months postpartum (% of participating mothers)
Online questionnaire at 4 months postpartum (time of measurement 2)
Prevalence of breastfeeding
Time Frame: Online questionnaire at 6 months postpartum (time of measurement 3)
Assessing the breastfeeding prevalence at 6 months postpartum (% of participating mothers)
Online questionnaire at 6 months postpartum (time of measurement 3)
Prevalence of breastfeeding
Time Frame: Online questionnaire at 12 months postpartum (time of measurement 4)
Assessing the breastfeeding prevalence at 12 months postpartum (% of participating mothers)
Online questionnaire at 12 months postpartum (time of measurement 4)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of exclusively, predominantly or partially breastfeeding: questionnaire
Time Frame: Online questionnaire at 4 times of measurement within the first year of life
The average duration of infants being breastfed exclusively, predominantly or partially at time of measurement 1 in days; at time of measurement 2-4 in months; according to the WHO indicators: proportion of infants under 6 months who are fed exclusively with breast milk, proportion of infants under 6 months who are fed predominantly with breast milk; additionally: proportion of infants under 6 months who are fed partially with breast milk
Online questionnaire at 4 times of measurement within the first year of life
Assessment of infant feeding if breastfeeding is not performed: questionnaire
Time Frame: Online questionnaire at 4 times of measurement within the first year of life
Proportion of infants receiving formula
Online questionnaire at 4 times of measurement within the first year of life
Infant nutrition, assessment of complimentary feeding: questionnaire
Time Frame: Online questionnaire at 4 times of measurement within the first year of life
Age of infant at initiation of complimentary feeding - in months; according to the WHO indicators: proportion of infants who received complementary food, proportion of infants who received 4 or more food groups
Online questionnaire at 4 times of measurement within the first year of life
Influence of factors on breastfeeding prevalence: questionnaire
Time Frame: Online questionnaire at 2 times of measurement (time of measurement 1 (14 days after delivery) and 4 (12 months after delivery))
Breastfeeding prevalence statistically dependent on socioeconomic factors and lifestyle and other general conditions - % of participating mothers
Online questionnaire at 2 times of measurement (time of measurement 1 (14 days after delivery) and 4 (12 months after delivery))
Influence of factors on breastfeeding duration: questionnaire
Time Frame: Online questionnaire at 2 times of measurement (time of measurement 1 (14 days after delivery) and 4 (12 months after delivery))
Breastfeeding duration statistically dependent on socioeconomic factors, lifestyle and other general conditions: Average duration of infants being fed at time of measurement 1: in days; at time of measurement 4: in months
Online questionnaire at 2 times of measurement (time of measurement 1 (14 days after delivery) and 4 (12 months after delivery))
Structure in the maternity wards: questionnaire
Time Frame: One online questionnaire at study start within the recruitment period (February/March 2019)
Proportion of participating maternity wards with BFHI certificate, offering rooming-in, providing information on breastfeeding and breastfeeding support
One online questionnaire at study start within the recruitment period (February/March 2019)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karin Schindler

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SukieAUT2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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