BreastfeedingPARTAGENCT07499466
Peer-Support Breastfeeding Program for Mothers in Severe Socioeconomic Deprivation: Feasibility Study
An observational study of Breastfeeding and Breastfeeding Support, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Breastfeeding Support, Health Disparities
- What is being tested?
- Peer-Support Breastfeeding Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of mothers experiencing severe socioeconomic deprivation with an infant hospitalized in the maternity or neonatal unit at the Hôpital Femme Mère Enfant (HFME), France. Eligible participants are adult mothers (≥18 years) who intend to breastfeed, have sufficient proficiency in French or a language spoken by available peer supporters, and provide oral agreement to participate. Mothers will be identified and recruited during their hospital stay. Approximately 20 eligible mothers are seen monthly in the unit. Based on eligibility criteria, expected refusal rates, and peer supporter availability (maximum two concurrent supports per peer), an estimated 5 to 8 mothers will be enrolled per month over 6 months, for a total sample of approximately 30 to 50 participants. Exclusion criteria include medical contraindications to breastfeeding, infants with life-threatening conditions, severe psychiatric conditions incompatible with participation, and legal guardianship.
Who may be able to join
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de néonatologie Hôpital Femme Mère Enfant
Bron, France, 69500
Marine BUTIN, Pr, 0427855286, Marine.butin@chu-lyon.fr
About this study
Official title: Feasibility Study of a Peer-Support Breastfeeding Resource and Support Program for Mothers Experiencing Severe Socioeconomic Deprivation
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.
Read more
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.
- Being tested
- Peer-Support Breastfeeding Intervention
- Keywords
- Peer support, Breastfeeding promotion, Socially deprived mothers
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-Support Breastfeeding InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Peer-Support Breastfeeding Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 months (duration of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Dec 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499466
- Sponsor's protocol ID
- 69HCL25_0764
- Other IDs
- 25-5239
- Acronym
- PARTAGE
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Peer-Support Breastfeeding Resource and Support Program for Mothers Experiencing Severe Socioeconomic Deprivation
- ClinicalTrials.gov ID
- NCT07499466
- Acronym / sponsor ID
- PARTAGE / 69HCL25_0764
- Keywords
- Peer support, Breastfeeding promotion, Socially deprived mothers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Behavioral: Peer-Support Breastfeeding InterventionInclusion 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of mothers experiencing severe socioeconomic deprivation with an infant hospitalized in the maternity or neonatal unit at the Hôpital Femme Mère Enfant (HFME), France. Eligible participants are adult mothers (≥18 years) who intend to breastfeed, have sufficient proficiency in French or a language spoken by available peer supporters, and provide oral agreement to participate. Mothers will be identified and recruited during their hospital stay. Approximately 20 eligible mothers are seen monthly in the unit. Based on eligibility criteria, expected refusal rates, and peer supporter availability (maximum two concurrent supports per peer), an estimated 5 to 8 mothers will be enrolled per month over 6 months, for a total sample of approximately 30 to 50 participants. Exclusion criteria include medical contraindications to breastfeeding, infants with life-threatening conditions, severe psychiatric conditions incompatible with participation, and legal guardianship.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-Support Breastfeeding InterventionThe 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. | Behavioural | Supported mothers |
Primary outcome
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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breastfeeding and Breastfeeding Support, run by Hospices Civils de Lyon 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 4 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie S LABORIE, MD (+33 (0)472115115, sophie.laborie@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Up to 2 months (duration of the intervention)). 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 30 Mar 2026.