Peer-Support Breastfeeding Program for Mothers in Severe... | NCT07499466

NCT07499466

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
25-5239	Other Identifier	HCL

Status Module

Description Module

Brief Summary

Breastfeeding provides well-established and "irreplaceable" health benefits for both mothers and infants. However, breastfeeding rates in France remain among the lowest in Europe and are strongly associated with socioeconomic status. Mothers experiencing severe socioeconomic deprivation, including those facing housing instability or migration-related challenges, may encounter additional barriers to breastfeeding, such as social isolation, limited access to health information, and linguistic or cultural obstacles.

Peer and community support have been shown to positively influence breastfeeding initiation and continuation. The Relais Allaitement Program (PRALL) is a peer-support program designed to promote breastfeeding and support early parenting through trained volunteer mothers. The PARTAGE project aims to adapt and pilot the PRALL program for mothers experiencing severe socioeconomic deprivation receiving care at the maternity unit of the Hôpital Femme Mère Enfant (HFME), in Bron, France.

This prospective, interventional, non-comparative feasibility study will evaluate the acceptability and feasibility of a peer-support breastfeeding program delivered by trained experienced mothers (peer supporters).

The intervention includes:

the adaptation of PRALL educational materials and training to the needs of vulnerable populations using participatory approaches and accessible communication principles,
the recruitment and training of two nursery nurses from the maternity unit to become network coordinators of the peer-support network,
the recruitment of experienced mothers who will be trained by the 2 network coordinators, to become breastfeeding peer supporters,
and the implementation of breastfeeding support by peer supporters for eligible mothers.

Eligible mothers experiencing severe socioeconomic deprivation will be offered support from a trained peer supporter during the postpartum period.

The primary outcome is the number of completed support interventions, defined as to have at least two in-person mother/peer supporter contacts and to last at least one month, unless breastfeeding cessation or infant death occurs earlier. Qualitative interviews with participating mothers and peer supporters will also be conducted to explore barriers and facilitators to breastfeeding support in this population.

The results will inform the adaptation of the PRALL program for vulnerable populations and assess the feasibility of implementing a peer-support breastfeeding intervention in this context. Findings may guide the development of a larger multicenter study to evaluate the impact of peer-support programs on breastfeeding outcomes among socially disadvantaged populations in France and potentially across Europe.

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Network coordinators	Healthcare professional working in the maternity unit of the Hôpital Femme Mère Enfant (HFME) Who has completed breastfeeding training of at least 3 days within the last 5 years Who is involved in the care and support of families with infants and young children, experiencing severe socioeconomic deprivation Previous experience facilitating a support group (optional) And having support from the employing institution to participate in the project and contribute to the development and coordination of a mother peer-support network
Peer supporters	Having breastfed at least one child while experiencing severe socioeconomic deprivation Having experienced breastfeeding as a positive experience Currently experiencing or having previously experienced severe socioeconomic deprivation Age ≥ 18 years Sufficient proficiency in French to communicate with network coordinators and supported mothers Availability to complete the peer-support training and to provide in-person support to mothers, including at least two face-to-face contacts during the support period
Supported mothers	Inclusion Criteria: Mother with at least one infant hospitalized in the maternity or neonatal unit at the Hôpital Femme Mère Enfant (HFME) Who Intents to breastfeed Who is in a severe socioeconomic deprivation Having sufficient proficiency in French or in one of the languages spoken by the available peer supporters to allow communication Aged 18 years or older Given verbal consent to participate in the study Exclusion Criteria: Having a medical contraindication to breastfeeding Having an infant with a known congenital condition with life-threatening prognosis Having a severe psychiatric condition considered incompatible with participation in the peer-support intervention Being under legal guardianship	Behavioral: Peer-Support Breastfeeding Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peer-Support Breastfeeding Intervention	Behavioral	The intervention consists of a peer-to-peer breastfeeding support, delivered over a 2-month period, designed to ensure continuity of support after discharge from the maternity ward, particularly for mothers in highly socioeconomic deprivation who are at high risk of losing access to care. An initial face-to-face meeting with a trained peer supporter is offered during the hospital stay. Another peer supporter may be reassigned if necessary, in accordance with the network coordinators. The intervention includes weekly contacts during the first month and biweekly contacts during the second month (approximately 6 contacts total), unless breastfeeding cessation or infant death occurs earlier. Contacts are preferably conducted face-to-face at a location chosen by the mother; telephone or video contacts may be used when needed, with at least 2 in-person meetings expected. The intervention is flexible and tailored to individual needs to support breastfeeding and maternal well-being.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of completed peer-support breastfeeding interventions defined by at least two in-person mother/peer supporter contacts and a duration and to last at least one month (unless breastfeeding cessation or infant death occurs earlier)	Acceptability will be assessed through the number of completed peer-support interventions and monitoring of peer supporter activity. Data regarding contacts (type of contact, topic discussed, and duration) will be reported by the peer mentors via phone/SMS to the coordination center and monthly meetings with network coordinators. Implementation data will be collected and analyzed descriptively by the coordination team to assess feasibility, fidelity, and maintenance of the adapted program. Confidentiality will be ensured.	Up to 2 months (duration of the intervention)

Eligibility Module

ID	Term
D005247	Feeding Behavior
D001519	Behavior