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Breast FeedingPED-PROM-BFNCT06323759

Perinatal EDucation: Pedagogical Strategy and Facilitators for the PROMotion of BreastFeeding

A study testing educational intervention in people with Breast Feeding, run by Lépine Alexandra at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Breastfeeding up to 6 months of a child's life, for its benefits to mother and child, has become a global public health goal. However, there is a disparity in the prevalence of breastfeeding (BF) in different regions of the world. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Feeding
What is being tested?
educational intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteFrance
Study dates
6 Feb 2023to 1 Mar 2024
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • for women for all pregnant women in Control Group \& Intervention Group:
  • Aged ≥ 18, French-speaking, with access to and use of the internet
  • Pregnant woman followed in one of the maternity wards, presenting with a simple pregnancy, physiological course
  • Consenting to participate in the research For Liberal Midwives
  • Participation on a voluntary basis
  • Experience teaching parenting and breastfeeding classes

Who cannot join

  • for women for all pregnant women in Control Group \& Intervention Group
  • Medical-gynecological history requiring medication management incompatible with lactation
  • History of breast surgery that contraindicates breastfeeding
  • Women without access to the Internet and who do not speak French.
  • Women refusing to participate in research.
  • For Liberal Midwives
  • Liberal midwives refusing to participate in research

Trial locations and contacts

1 site in 1 country.

France1 site
  • Université Sorbonne Paris Nord - Laboratoire d'Educations et Promotion de la Santé - UR 3412

    Bobigny, 93017

Other trials in France

About this study

Breastfeeding up to 6 months of a child's life, for its benefits to mother and child, has become a global public health goal. However, there is a disparity in the prevalence of breastfeeding (BF) in different regions of the world. According to French perinatal surveys, the rate of BF at birth decreased significantly between 2010 and 2016. Even if that figure remains stable according to the last perinatal survey in 2021, it decreases sharply, to 34.4%, at 2 months.While many plans at the national level advocate for BF, it is rare to see an action plan or an education intervention for women and couples aimed at promoting BF. However, women's needs to educate about BF and the need for professionals to reflect on their practices are highlighted by numerous perinatal surveys. It should be noted that despite the importance given to the promotion of BF found in all National Nutrition and Health Programs, none of them provide pedagogical means or an education program to achieve the objectives set. At present, in France, there is no breastfeeding education program and professionals accompany women by implementing experimental actions without considering the complexity of the promotional dimension (producing a behavioral change) and the educational dimension (understanding the pedagogy of the proposed actions)

Read the detailed description

The benefits of exclusive breastfeeding for infants and mothers are widely recognized by the scientific community.

As a result, its promotion has become a global public health goal: 75% of newborns should be breastfed by 2030. According to the World Health Organization (WHO), the global average for exclusive breastfeeding has increased from 14% in 1985 to 37% in 2015. The WHO report also notes a disparity in the prevalence of exclusive breastfeeding at birth and at six months of age.

According to the National Health Nutrition Programs and the recommendations of Public Health France and the French Society of Pediatrics, the promotion of exclusive breastfeeding remains the main preventive measure to combat health inequalities from childhood to ensure healthy and equitable development. They emphasize the education of mothers and/or couples, providing women with "know-how to act" by acquiring knowledge, developing management skills, and building self-confidence and motivation. However, these plans set quantified objectives, but do not propose educational actions or interventions to promote BF, and even less indicate the means for professionals to achieve these objectives.

In France, couples and/or women can, if they wish, benefit from birth and parenting preparation sessions offered by midwives in the prenatal period. One of these sessions is dedicated to encouraging and educating pregnant women to breastfeed. In the postnatal period, despite an increase in the number of staff trained to support breastfeeding mothers, more than 84% of couples are referred to breastfeeding support networks outside the maternity unit (PMI, private midwives, associations). Even the practice of early discharge (stay < 2 days) for low-risk women has inevitably reduced the time spent by hospital staff in educating women. At present, this activity is outsourced and carried out by private midwives, who carry out between 2 and 3 early postnatal follow-up consultations to assess the mother's and newborn's needs on a medical, psycho-educational level. These consultations are not mandatory but are strongly recommended.

Further scientific research:

A scoping review of international publications carried out in 2020 made it possible to draw a map of the pedagogical methods practiced, to identify some of their characteristics favoring the initiation and duration of BF, and to demonstrate that professionals rarely refer to a pedagogical strategy and conditions favorable to learning to ensure a better promotion of BF. The areas for improvement identified can be considered in order to better adapt educational strategies in terms of their pedagogical design. In addition to this literature review, a multicenter and prospective survey will be carried out among breastfeeding women and hospital midwives who led the childbirth preparation sessions to identify, on the one hand, the educational needs of breastfeeding women and, on the other hand, the educational strategies proposed by caregivers to promote BF. This study has been approved by the Ethics Committee of the Sorbonne University N°CER-2021-119 and is registered in the ClinicalTrials.gov registry: NCT05271812.

The survey highlights that, overall, the educational needs expressed by breastfeeding women and the educational approaches taken by midwives correlate with the educational characteristics identified in the Scope Review. Midwives' pedagogical attitudes as well as the educational strategies they propose seem to have an impact on the reinforcement of the decision to breastfeed and the continuation of this decision in the longer term. The perceived usefulness of the educational session is expressed in the reinforcement of the motivation to breastfeed, the development of self-esteem and the feeling of self-management (competence to manage their breastfeeding). We also identified the pedagogical characteristics of the educational sessions offered by midwives. Thus, this review of the literature, coupled with the survey of women's educational strategies and needs, has allowed us to draw up pedagogical guidelines that can be built around a more adapted engineering to promote BF.

Based on the results of the scoping review and the primary study, we modeled an educational intervention based on a strategy, including favorable conditions, to promote breastfeeding.

The research question is therefore: Can an adapted educational intervention based on an educational strategy and conducive learning conditions improve the promotion of breastfeeding? Theoretical framework: This research focuses on the pedagogical dimension and, more specifically, on improving the pedagogical engineering of current educational interventions (in the context of antenatal and postnatal follow-up of women) and their contribution to the maintenance of breastfeeding from the point of view of women and professionals.

This is a systemic approach based on evaluations of therapeutic education programs. It allows for a more comprehensive and different approach to biomedical and clinical research that attempts to demonstrate the effectiveness of a program or intervention in BF promoting without explaining the didactics of the programs.

The evaluation framework of this model is based on critical realism. It is proposed by Greenhalgh, Harvey and Walshe and explained in the RAMESES II reporting standards for realist evaluations. Numerous publications, by Ridde.V and Robert.E, confirm the relevance of the pragmatic approach, which allows researchers to explain what works in a program, for what reasons and in what contexts. It makes it possible to establish an explanatory theory for a program model, according to the contexts that influence it and the mechanisms that hinder effects. Bearing in mind that these operations are not linear and that the expected effects (results) may be different depending on the conditions of time, place, individuals themselves, social, cultural, political, and economic organizations. It is a multi-center, comparative, mixed-methods study with a comprehensive approach. Realistic evaluation shows what works and what does not work in a program, and how and to what effect. It enables the construction of an explanatory theory in terms of contexts of influence, generative mechanisms, and effects produced in the BF ecosystem.

This is a sequential and explanatory mixed-methods study (QUANTI-Quali). Quantitative data will be analyzed using R software, while qualitative data analysis will be conducted using Atlas-Ti software.

Conditions
Breast Feeding
Being tested
educational intervention
Keywords
Breast Feeding Promotion, Pedagogical Strategy
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • educational interventionOther

    In antenatal breastfeeding education: Theoretical contributions on BF (physiology of lactation, frequency complications), hands-on workshop, Provision of educational tools to promote the learning environment: breastfeeding booklet, educational video on breastfeeding, link to a BF specific platform, access to a telephone platform. In short-term postnatal breastfeeding education: Three systematic fallow-up at home or at midwives' office are planned. During these visits, a time of systematic discussion is planned with the nursing mothers. Their knowledge and ability to manage their breastfeeding are checked. The physiology of lactation, the gestures of breastfeeding and the occurrence of common complications are systematically recalled by the liberal midwife. In long-term postnatal breastfeeding education: Invitation of nursing mothers to breastfeeding information meetings at 2nd and 4th month after birth. These meetings will be facilitated either by the liberal midwives.

Study groups in NCT06323759
Study groupRoleWhat they receive
CONTROL GROUPNo interventionPregnant women have taken a routine parenthood preparation courses and follow-up by independent midwives in antenatally
INTERVENTION GROUPOtherPregnant women have taken a new parenthood preparation courses and follow-up by independent midwives in antenatality, postnatality short term, and postnatality long term)
Receives: Other: educational intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To find out the contribution of educational engineering to the choice and continuation of breastfeeding from the point of view of women until 4 months after the birth of the child.

    The percentage of women who are exclusively breastfeeding. They will be asked about their breastfeeding status at 15 days, 1 month, 2 months, and 4 months.

    Measured: T1: Prenatal: during the 9th month of pregnancy T2: Postnatal: during the 1st week after returning home T3: Postnatal: during the 3rd week of returning home T4: Postnatal: during the 8th week of return home, i.e. 2nd month after the birth of the child

Secondary outcomes (3)
  1. To explain contexts and generative mechanisms of pedagogical design that influence breastfeeding management up to 4 months afther birth.

    To measure women's perception of usefulness in the pedagogical design of the educational intervention for the management of breastfeeding and its complications.Women will be surveyed using closed-ended questions to assess their level of competence in breastfeeding management based on what they have learned, the content of the course, and practice of the gestures they have learned.

    Level of understanding, level of importance felt by breastfeeding women, and level of satisfaction with the courses are measured on a 4-point Likert scale. The level of influence of the courses on women's motivation to continue breastfeeding is measured on a 10-point nuance scale. Closed-ended questions about self-efficacy in breastfeeding management are administered to women.

    Measured: T2: Postnatal: during the 1st week after returning home T3: Postnatal: during the 3rd week of returning home T4: Postnatal: during the 8th week of return home, i.e. 2nd month after the birth of the child

  2. To explain interactions between existing contexts, generative mechanisms and effects on women's breastfeeding management skills.

    To measure the development of women's conative skills through the educational intervention and in different breastfeeding situations.Women will be interviewed using closed-ended questions to assess their feelings of self-esteem and commitment to breastfeeding based on 9 and 11 items respectively using 10-point nuanced scales. Two open-ended questions about self-esteem and breastfeeding commitment are included so that interviewed women can explain their responses.

    Measured: T2: Postnatal: during the 1st week after returning home T3: Postnatal: during the 3rd week of returning home T4: Postnatal: during the 8th week of return home, i.e. 2nd month after the birth of the child

  3. To determine contexts and generative mechanisms of pedagogical design that influence women's knowledge of breastfeeding up to 4 months afther birth.

    The perception of learning to manage breastfeeding and its most common complications. Women will be interviewed using closed-ended questions to assess their self-efficacy in managing their breastfeeding. This involves the short version of the breastfeeding self-efficacy scale. Fourteen items are evaluated on a 4-point Likert scale. An open-ended question is included so that interviewed women can explain their responses.

    Measured: T2: Postnatal: during the 1st week after returning home T3: Postnatal: during the 3rd week of returning home T4: Postnatal: during the 8th week of return home, i.e. 2nd month after the birth of the child

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2024
  2. Study start6 Feb 2023
  3. Primary completion1 Mar 2024
  4. Study completion1 Mar 2024

Resources

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
Other
Allocation
Non-randomised
Intervention model
Sequential
Model description
This intervention is based on a pedagogical engineering that proposes a favorable learning environment more adapted than the courses already offered in preparing for parenthood and promoting breastfeeding
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06323759
Sponsor's protocol ID
2022-14
Acronym
PED-PROM-BF
Status last verified
Mar 2024
First submitted
10 Mar 2024
Last updated
21 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual data collected will be shared with other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing educational intervention in people with Breast Feeding, run by Lépine Alexandra at 1 site in France.

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 6 inclusion and 7 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 Mar 2024. 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 France. 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.

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?

To find out the contribution of educational engineering to the choice and continuation of breastfeeding from the point of view of women until 4 months after the birth of the child. (time frame: T1: Prenatal: during the 9th month of pregnancy T2: Postnatal: during the 1st week after returning home T3: Postnatal: during the 3rd week of returning home T4: Postnatal: during the 8th week of return home, i.e. 2nd month after the birth of the child). 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 Mar 2024.

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