- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04137796
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:
- the current breastfeeding rates
- 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
- 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
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
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
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-
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Vienna, Austria
- Medical University of Vienna, Vienna General Hospital
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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
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
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).
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Online questionnaire at 14 days postpartum (time of measurement 1)
|
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Prevalence of breastfeeding
Time Frame: Online questionnaire at 14 days postpartum (time of measurement 1)
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Assessing the breastfeeding prevalence at 14 days postpartum (% of participating mothers)
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Online questionnaire at 14 days postpartum (time of measurement 1)
|
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Prevalence of breastfeeding
Time Frame: Online questionnaire at 4 months postpartum (time of measurement 2)
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Assessing the breastfeeding prevalence at 4 months postpartum (% of participating mothers)
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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)
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Assessing the breastfeeding prevalence at 6 months postpartum (% of participating mothers)
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Online questionnaire at 6 months postpartum (time of measurement 3)
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Prevalence of breastfeeding
Time Frame: Online questionnaire at 12 months postpartum (time of measurement 4)
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Assessing the breastfeeding prevalence at 12 months postpartum (% of participating mothers)
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Online questionnaire at 12 months postpartum (time of measurement 4)
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Secondary Outcome Measures
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
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Online questionnaire at 4 times of measurement within the first year of life
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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
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Proportion of infants receiving formula
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Online questionnaire at 4 times of measurement within the first year of life
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Infant nutrition, assessment of complimentary feeding: questionnaire
Time Frame: Online questionnaire at 4 times of measurement within the first year of life
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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
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Online questionnaire at 4 times of measurement within the first year of life
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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))
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Breastfeeding prevalence statistically dependent on socioeconomic factors and lifestyle and other general conditions - % of participating mothers
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Online questionnaire at 2 times of measurement (time of measurement 1 (14 days after delivery) and 4 (12 months after delivery))
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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))
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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))
|
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Structure in the maternity wards: questionnaire
Time Frame: One online questionnaire at study start within the recruitment period (February/March 2019)
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Proportion of participating maternity wards with BFHI certificate, offering rooming-in, providing information on breastfeeding and breastfeeding support
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One online questionnaire at study start within the recruitment period (February/March 2019)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 1, 2019
Primary Completion (Actual)
May 5, 2019
Study Completion (Actual)
April 25, 2020
Study Registration Dates
First Submitted
October 4, 2019
First Submitted That Met QC Criteria
October 22, 2019
First Posted (Actual)
October 24, 2019
Study Record Updates
Last Update Posted (Actual)
September 2, 2020
Last Update Submitted That Met QC Criteria
September 1, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Other Study ID 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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