BreastfeedingPhase 1NCT00145834
Early Breastfeeding Cessation - is It Possible to Prevent?
A Phase 1 study testing community based trial in people with Breastfeeding and Practice, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate if a postnatal public health breastfeeding intervention relying on the importance of the psychosocial factors can prolong the period with exclusive breastfeeding duration among mothers who want to breastfeed. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Breastfeeding, Practice, Maternal Behaviour
- What is being tested?
- community based trial
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,456 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2004to Apr 2005
- Phase
- Phase 1
- 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 0 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Danish mother, single child, gestational age of not less than 37 full weeks
Who cannot join
- Mothers with an ethic background other than Danish, preterm delivery,twin birth
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Publich Health, Department of Nursing Science, University of Aarhus
Aarhus, DK-8000 Aarhus C
About this study
Official title: A Randomised Community Based Experimental Trial in the Health Visitor's Practice Field
The purpose of this study is to investigate if a postnatal public health breastfeeding intervention relying on the importance of the psychosocial factors can prolong the period with exclusive breastfeeding duration among mothers who want to breastfeed.
Read the detailed description
Breastfeeding is a complex learned behaviour and not a capability which comes naturally with motherhood. Different types of professional recommendations have been used to support the new mother in this process.
Randomised studies have shown that postnatal support can influence the breastfeeding duration positively. Various studies has offered different kinds of interventions with home visits and/or telephone calls as the generally used approach, but the proper follow-up on the breastfeeding support in the postnatal period after the mother leaves the hospital is not yet clear.
- Conditions
- Breastfeeding, Practice, Maternal Behaviour, Self-Efficacy
- Being tested
- community based trial
- Keywords
- psychosocial factors, breastfeeding, postnatal intervention, health visitor
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
community based trialBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding duration
Secondary outcomes (1)
Satisfaction with the breastfeeding period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startFeb 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,456 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation, Sygekassernes Helsefond, Ringkjobing Amt, Ribe Amt
- Investigators
- Ingegerd Harder, Ph.D., Study director, Department of Nursing Science, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145834
- Sponsor's protocol ID
- SUN-2002-653
- Status last verified
- Sep 2005
- First submitted
- 1 Sep 2005
- Last updated
- 5 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Community Based Experimental Trial in the Health Visitor's Practice Field
- ClinicalTrials.gov ID
- NCT00145834
- Acronym / sponsor ID
- SUN-2002-653
- Conditions
- Breastfeeding, Practice, Maternal Behaviour, Self-Efficacy
- Keywords
- psychosocial factors, breastfeeding, postnatal intervention, health visitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,456 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Lundbeck Foundation, Sygekassernes Helsefond, Ringkjobing Amt, Ribe Amt
- Study start
- Feb 2004
- Study completion
- Apr 2005
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate if a postnatal public health breastfeeding intervention relying on the importance of the psychosocial factors can prolong the period with exclusive breastfeeding duration among mothers who want to breastfeed.
Detailed description
Breastfeeding is a complex learned behaviour and not a capability which comes naturally with motherhood. Different types of professional recommendations have been used to support the new mother in this process.
Randomised studies have shown that postnatal support can influence the breastfeeding duration positively. Various studies has offered different kinds of interventions with home visits and/or telephone calls as the generally used approach, but the proper follow-up on the breastfeeding support in the postnatal period after the mother leaves the hospital is not yet clear.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Danish mother, single child, gestational age of not less than 37 full weeks
Key exclusion criteria (1 listed)
- Mothers with an ethic background other than Danish, preterm delivery,twin birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| community based trial | Behavioural | – |
Primary outcome
Breastfeeding duration
1 secondary outcome
Satisfaction with the breastfeeding period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingegerd Harder, Ph.D. study director
Department of Nursing Science, University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing community based trial in people with Breastfeeding and Practice, run by University of Aarhus at 1 site in Denmark.
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 1 inclusion and 1 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 5 Sep 2005. 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 Denmark. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Breastfeeding duration. 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 5 Sep 2005.