跳至主要内容
临床试验/NCT07499466
NCT07499466招募中不适用

Feasibility Study of a Peer-Support Breastfeeding Resource and Support Program for Mothers Experiencing Severe Socioeconomic Deprivation

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
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)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • - 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

结局指标

主要结局

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)

时间窗: Up to 2 months (duration of the intervention)

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验