NCT06323759

Brief 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. 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

March 10, 2024

Last Update Submit

March 14, 2024

Conditions

Keywords

Breast Feeding PromotionPedagogical Strategy

Outcome Measures

Primary Outcomes (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.

    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)

  • To explain contexts and generative mechanisms of pedagogical design that influence breastfeeding management up to 4 months afther birth.

    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

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

    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

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

    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

Other Outcomes (1)

  • To evaluate the level of satisfaction about the educational intervention among nursing mothers.

    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

Study Arms (2)

CONTROL GROUP

NO INTERVENTION

Pregnant women have taken a routine parenthood preparation courses and follow-up by independent midwives in antenatally

INTERVENTION GROUP

OTHER

Pregnant women have taken a new parenthood preparation courses and follow-up by independent midwives in antenatality, postnatality short term, and postnatality long term)

Other: educational intervention

Interventions

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.

INTERVENTION GROUP

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bobigny, 93017, France

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Mehrnoosh Yazdanbakhsh

    Université Sorbonne Paris Nord Laboratoire d'Educations et Promotion de la santé - UR3412

    PRINCIPAL INVESTIGATOR
  • Rémi Gaganyre

    Université Sorbonne Paris Nord Laboratoire d'Educations et Promotion de la santé - UR3412

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
responsable-bred@univ-paris.fr

Study Record Dates

First Submitted

March 10, 2024

First Posted

March 21, 2024

Study Start

February 6, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

No individual data collected will be shared with other researchers.

Locations