CClinicalTrials.gg
CompletedNCT02989766Updated Nov 21, 2017

A Self-Guided Breastfeeding Program

An interventional study of Education on Breast Feeding in Breastfeeding, sponsored by St. Louis University. Completed. Open to female participants aged 14 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-21.

Sponsored by St. Louis University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Aug 2015, registered Oct 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
335
Allocation
Randomized
Ages
14 Years to 55 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Breastfeeding
03

In context

Lead sponsor

St. Louis University is the lead sponsor of 152 studies on the registry; 17 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients \< 32 weeks gestation.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
335 participants (actual)

Study arms

  • Active comparator
    A - Intervention

    Education on Breast Feeding 3 activity sheets prenatally-study related. Complete a pre-questionnaire, a pre-delivery and a postpartum questionnaire

    Behavioral: Education on Breast Feeding

  • No intervention
    B - Standard of Care

    Complete a pre-questionnaire, a pre-delivery and a postpartum questionnaire

Interventions

  • BehavioralEducation on Breast Feeding

    Subjects in the intervention arm will complete 3 activity sheets prenatally-study related.

06

What researchers measure

Primary outcomes

  1. improving duration of BF.

    It was propose using a 3-part prenatal self-help guide to educate and prepare mothers for breastfeeding.

    Time frame: 16 Months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02989766
Lead sponsor
St. Louis University
Responsible party
Jaye Shyken, MD (MD, St. Louis University) — Principal investigator
First posted
Dec 12, 2016
Start date
Aug 20, 2015
Primary completion
Jul 27, 2017
Completion
Jul 27, 2017
Last update
Nov 21, 2017

Study contacts

Jaye Shyken, MD
principal investigator · St. Louis University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion