BreastfeedingNCT02989766
A Self-Guided Breastfeeding Program
A study testing Education on Breast Feeding in people with Breastfeeding, run by St. Louis University.
Trial summary
This intervention would be a series of self-help-style educational and motivational activity sheets for patients to complete independently. This will be a randomized clinical control trial. Subjects will complete a pre delivery questionnaire and a postpartum questionnaire. Read more about this study
- Who is it for?
- Ages 14 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Education on Breast Feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2015to 27 Jul 2017
- Phase
- Interventional
- 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 14 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients < 32 weeks gestation.
Who cannot join
- Patient who have not had an ultrasound confirming viable intrauterine pregnancy.
- Patients beyond 32 weeks gestation will be excluded as some are unlikely to return for a sufficient number of prenatal visits to complete the intervention.
- Patients with medical contraindications to breastfeeding such as HIV or active substance abuse.
- Patients planning to take medications in the postpartum period that are incompatible with breastfeeding such as anti-metabolites.
- Patients giving birth to a nonviable infant.
- Patients without adequate reading and writing skills to complete the questionnaires and activity sheets.
About this study
Official title: Preparing Mothers for Feeding Their Newborns: A Self-Guided Program for Pregnant Women
This intervention would be a series of self-help-style educational and motivational activity sheets for patients to complete independently. This will be a randomized clinical control trial.
Subjects will complete a pre delivery questionnaire and a postpartum questionnaire. Subjects in the intervention arm will complete 3 activity sheets prenatally during their wait time at the clinic. The first worksheet can be completed the day of recruitment after consent is signed.
Subjects will be contacted by phone at 3 and 6 months postpartum to assess long term duration of breast feeding.
Read the detailed description
As the benefits of human milk become evident, the investigators are striving to improve the breastfeeding (BF) rate among new mothers. In April and May of 2014, 73 (71%) of well babies received human milk at discharge from our postpartum unit, with 40 (35%) and receiving human milk exclusively. In the neonatal intensive care unit, 83 (89%) received human milk during those months.
Many of the patients at the teaching institution share risk factors for failure to BF, including poverty, obesity, unplanned pregnancy and being African American. Efforts have had limited effect in improving initiation and duration among these patients.
Studies examining the efficacy of various modalities of antenatal education produced modest results in improving initiation and duration of BF. Several studies examined group BF education versus routine prenatal care without significant differences in initiation, exclusivity (the practice of using human milk exclusively and not supplementing with formula) or duration. Conversely, other study showed a difference in initiation with group education and showed a difference in exclusivity. Formalized education compared to routine clinical practice education did not result in a difference in exclusivity in several studies and neither did a program that included a video showed a difference in initiation with formal education.
A few studies compared peer counseling to routine prenatal care. One small study of 59 women found an increase in initiation rate, while a larger study of 2511 women did not find a difference in initiation or duration.
Other studies found no significant difference in initiation, duration or exclusivity with an educational program on practical BF skills nor a program on BF attitudes. A small study that paired BF education with material incentives increased exclusivity. Three studies comparing interventions by lactation consultants found no difference in initiation or duration, although one study showed improvement in exclusivity. Postpartum BF self-efficacy correlates with BF duration and two studies showed improvement in exclusivity with a BF class based on principles of self-efficacy. These studies based their intervention on Bandura's theory of self-efficacy, which proposes that an individual's expectation of personal efficacy will determine her initiation of coping behavior, effort expenditure and duration of persistence. This theory recognizes four components that contribute to an individual's sense of self- efficacy, and these include performance accomplishment, vicarious, or social, experience, verbal persuasion and psychological state. developed a validated scale at measuring prenatal maternal self-efficacy in breastfeeding.
These two studies used a teaching approach that assumes that pregnant women are adults who are self-motivated and have past experience that shapes their learning and are a component to their perception of self-efficacy.
Printed self-help materials are appealing as a low cost intervention that could be widely implemented. Furthermore, a large study among pregnant women showed that a self-help guide that is particularly tailored towards pregnant women could be effective in promoting another healthy behavior modification: smoking cessation. Potentially this method could be effective when used to prepare mothers for breastfeeding.
- Conditions
- Breastfeeding
- Being tested
- Education on Breast Feeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education on Breast FeedingBehavioural
Subjects in the intervention arm will complete 3 activity sheets prenatally-study related.
| Study group | Role | What they receive |
|---|---|---|
| A - Intervention | Active comparator | Education on Breast Feeding 3 activity sheets prenatally-study related. Complete a pre-questionnaire, a pre-delivery and a postpartum questionnaire Receives: Behavioral: Education on Breast Feeding |
| B - Standard of Care | No intervention | Complete a pre-questionnaire, a pre-delivery and a postpartum questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
improving duration of BF.
It was propose using a 3-part prenatal self-help guide to educate and prepare mothers for breastfeeding.
Measured: 16 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start20 Aug 2015
- Primary completion27 Jul 2017
- Study completion27 Jul 2017
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.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaye Shyken, MD, St. Louis University
- Investigators
- Jaye Shyken, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989766
- Sponsor's protocol ID
- 25115
- Status last verified
- Nov 2017
- First submitted
- 18 Oct 2016
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing Mothers for Feeding Their Newborns: A Self-Guided Program for Pregnant Women
- ClinicalTrials.gov ID
- NCT02989766
- Acronym / sponsor ID
- 25115
- Conditions
- Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 20 Aug 2015 (actual)
- Primary completion
- 27 Jul 2017 (actual)
- Study completion
- 27 Jul 2017 (actual)
- First posted
- 12 Dec 2016 (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.
This intervention would be a series of self-help-style educational and motivational activity sheets for patients to complete independently. This will be a randomized clinical control trial.
Subjects will complete a pre delivery questionnaire and a postpartum questionnaire. Subjects in the intervention arm will complete 3 activity sheets prenatally during their wait time at the clinic. The first worksheet can be completed the day of recruitment after consent is signed.
Subjects will be contacted by phone at 3 and 6 months postpartum to assess long term duration of breast feeding.
Detailed description
As the benefits of human milk become evident, the investigators are striving to improve the breastfeeding (BF) rate among new mothers. In April and May of 2014, 73 (71%) of well babies received human milk at discharge from our postpartum unit, with 40 (35%) and receiving human milk exclusively. In the neonatal intensive care unit, 83 (89%) received human milk during those months.
Many of the patients at the teaching institution share risk factors for failure to BF, including poverty, obesity, unplanned pregnancy and being African American. Efforts have had limited effect in improving initiation and duration among these patients.
Studies examining the efficacy of various modalities of antenatal education produced modest results in improving initiation and duration of BF. Several studies examined group BF education versus routine prenatal care without significant differences in initiation, exclusivity (the practice of using human milk exclusively and not supplementing with formula) or duration. Conversely, other study showed a difference in initiation with group education and showed a difference in exclusivity. Formalized education compared to routine clinical practice education did not result in a difference in exclusivity in several studies and neither did a program that included a video showed a difference in initiation with formal education.
A few studies compared peer counseling to routine prenatal care. One small study of 59 women found an increase in initiation rate, while a larger study of 2511 women did not find a difference in initiation or duration.
Other studies found no significant difference in initiation, duration or exclusivity with an educational program on practical BF skills nor a program on BF attitudes. A small study that paired BF education with material incentives increased exclusivity. Three studies comparing interventions by lactation consultants found no difference in initiation or duration, although one study showed improvement in exclusivity. Postpartum BF self-efficacy correlates with BF duration and two studies showed improvement in exclusivity with a BF class based on principles of self-efficacy. These studies based their intervention on Bandura's theory of self-efficacy, which proposes that an individual's expectation of personal efficacy will determine her initiation of coping behavior, effort expenditure and duration of persistence. This theory recognizes four components that contribute to an individual's sense of self- efficacy, and these include performance accomplishment, vicarious, or social, experience, verbal persuasion and psychological state. developed a validated scale at measuring prenatal maternal self-efficacy in breastfeeding.
These two studies used a teaching approach that assumes that pregnant women are adults who are self-motivated and have past experience that shapes their learning and are a component to their perception of self-efficacy.
Printed self-help materials are appealing as a low cost intervention that could be widely implemented. Furthermore, a large study among pregnant women showed that a self-help guide that is particularly tailored towards pregnant women could be effective in promoting another healthy behavior modification: smoking cessation. Potentially this method could be effective when used to prepare mothers for breastfeeding.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - Intervention | Active comparator | Behavioral: Education on Breast FeedingEducation on Breast Feeding 3 activity sheets prenatally-study related. Complete a pre-questionnaire, a pre-delivery and a postpartum questionnaire |
| B - Standard of Care | No intervention | –Complete a pre-questionnaire, a pre-delivery and a postpartum questionnaire |
Who may qualify
- Ages
- 14 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients < 32 weeks gestation.
Key exclusion criteria (6 listed)
- Patient who have not had an ultrasound confirming viable intrauterine pregnancy.
- Patients beyond 32 weeks gestation will be excluded as some are unlikely to return for a sufficient number of prenatal visits to complete the intervention.
- Patients with medical contraindications to breastfeeding such as HIV or active substance abuse.
- Patients planning to take medications in the postpartum period that are incompatible with breastfeeding such as anti-metabolites.
- Patients giving birth to a nonviable infant.
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 |
|---|---|---|
| Education on Breast FeedingSubjects in the intervention arm will complete 3 activity sheets prenatally-study related. | Behavioural | A - Intervention |
Primary outcome
improving duration of BF.
Time frame: 16 Months
It was propose using a 3-part prenatal self-help guide to educate and prepare mothers for breastfeeding.
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 21 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Jaye Shyken, MD principal investigator
St. Louis University
Questions about this trial
What is this clinical trial studying?
A study testing Education on Breast Feeding in people with Breastfeeding, run by St. Louis University.
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 6 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 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
improving duration of BF. (time frame: 16 Months). 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 21 Nov 2017.