NCT07499466 Peer-Support Breastfeeding Program for Mothers in Severe Socioeconomic Deprivation: Feasibility Study
| NCT ID | NCT07499466 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Breastfeeding |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-12-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07499466 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breastfeeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07499466 currently recruiting?
Yes, NCT07499466 is actively recruiting participants. Contact the research team at sophie.laborie@chu-lyon.fr for enrollment information.
Where is the NCT07499466 trial being conducted?
This trial is being conducted at Bron, France.
Who is sponsoring the NCT07499466 clinical trial?
NCT07499466 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 50 participants.