NCT07806942

Brief Summary

The first months of life are considered a critical period that has a lasting impact on a child's future health. Breastfeeding is one of the fundamental factors contributing to healthy growth in children. It is reducing infant mortality, and supporting neurocognitive development. As part of the Nutri Pou Ti'moun program, a study on breastfeeding practices was conducted in French Guiana in 2024 to assess the current state of affairs. A complementary qualitative study of 15 mothers in situations of multidimensional vulnerability revealed barriers to exclusive breastfeeding, such as the perception of a lack of milk, the newborn's perceived refusal to breastfeed, or a lack of support from family and friends. The findings of these 2 studies encourage the investigators to support mothers in their choice to breastfeed from the moment they give birth, so that infant feeding practices align more closely with national and international recommendations and are as beneficial as possible for the child's health. The objective of this study is to compare the rate of exclusive breastfeeding at 1 month between women who received the intervention (exposed group) and those who did not (unexposed group). The study hypothesis is that the health intervention will improve the rate of exclusive breastfeeding.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
960

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started May 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
May 2026May 2029

Study Start

First participant enrolled

May 26, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 2, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

3 years

First QC Date

June 2, 2026

Last Update Submit

September 1, 2026

Conditions

Keywords

mediationbreastfeedingpost-partumpopulation health intervention research

Outcome Measures

Primary Outcomes (1)

  • Rate of exclusive breastfeeding at 1 month postpartum in the group of women who received health mediation support (exposed group) and in the group of women who did not receive such support (unexposed group).

    Measurement of the rate of exclusive breastfeeding using a questionnaire administred to mothers included in the study

    1 month

Secondary Outcomes (10)

  • Rate of exclusive breastfeeding

    1 month; 3 months

  • Duration of exclusive breasfeeding

    1 month; 3 months

  • Characteristics of the exposed group, including socioeconomic and medical data and the level of health literacy.

    At enrollment

  • Level of satisfaction within the maternity ward

    At enrollment

  • Level of support for breastfeeding

    At enrollment

  • +5 more secondary outcomes

Study Arms (2)

exposed group

women who received health mediation services

Other: postpartum breastfeeding support from a health mediator

control group

women who did not receive health mediation services

Other: routine health care without health mediation

Interventions

routine health care for postpartum breastfeeding

control group

This pilot mediation program consists of the following activities: * Supporting healthcare teams in providing postpartum care for women, particularly those in vulnerable situations. * Providing in-room support to women to assist them with breastfeeding in collaboration with the healthcare teams. The content of the support is tailored to the woman's needs and follows national guidelines. This support may be provided multiple times during the hospital stay. This individual in-room support is provided at the request of the woman and/or the healthcare team. The initial request and the content of the intervention are recorded in the woman's electronic medical record. * Participate weekly in the childbirth and parenting preparation workshop on breastfeeding, organized by the maternity ward and led by midwives and/or childcare assistants.

exposed group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who gave birth at the French Guiana University Hospital Center

You may qualify if:

  • Women who gave birth at the French Guiana University Hospital Center

You may not qualify if:

  • Women refusal to participate to the study or lack of opposition collected
  • lack of authorization from legal representatives for underage women or from legal guardians for women under legal protection
  • foetal death, stillbirth, or neonatal death
  • feeding with formula from birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier de Cayenne

Cayenne, Guyane, 97300, French Guiana

RECRUITING

Related Publications (10)

  • Basu S, Meghani A, Siddiqi A. Evaluating the Health Impact of Large-Scale Public Policy Changes: Classical and Novel Approaches. Annu Rev Public Health. 2017 Mar 20;38:351-370. doi: 10.1146/annurev-publhealth-031816-044208.

  • Dennis CL, McQueen K, Dol J, Brown H, Beck C, Shorey S. Psychometrics of the breastfeeding self-efficacy scale and short form: a systematic review. BMC Public Health. 2024 Feb 29;24(1):637. doi: 10.1186/s12889-024-17805-6.

  • Pugh LC, Serwint JR, Frick KD, Nanda JP, Sharps PW, Spatz DL, Milligan RA. A randomized controlled community-based trial to improve breastfeeding rates among urban low-income mothers. Acad Pediatr. 2010 Jan-Feb;10(1):14-20. doi: 10.1016/j.acap.2009.07.005. Epub 2009 Oct 23.

  • Chapman DJ, Morel K, Anderson AK, Damio G, Perez-Escamilla R. Breastfeeding peer counseling: from efficacy through scale-up. J Hum Lact. 2010 Aug;26(3):314-26. doi: 10.1177/0890334410369481.

  • McLeish J, Redshaw M. Peer support during pregnancy and early parenthood: a qualitative study of models and perceptions. BMC Pregnancy Childbirth. 2015 Oct 12;15:257. doi: 10.1186/s12884-015-0685-y.

  • Basurko C, Lyonnais E, Proquot M, Forsans G, Hcini N, Camara N, Galindo MS, Gatti C, Adenis A; NPTM study team; Nacher M, Savy M. Prevalence and risk factors of food insecurity during pregnancy: a multicenter survey in French Guiana. BMC Public Health. 2025 May 23;25(1):1910. doi: 10.1186/s12889-025-23173-6.

  • Suri S, Verlato G, Ray S. Editorial: The first 1000 days: window of opportunity for child health and development. Front Nutr. 2025 Aug 18;12:1673003. doi: 10.3389/fnut.2025.1673003. eCollection 2025. No abstract available.

  • Duijts L, Jaddoe VW, Hofman A, Moll HA. Prolonged and exclusive breastfeeding reduces the risk of infectious diseases in infancy. Pediatrics. 2010 Jul;126(1):e18-25. doi: 10.1542/peds.2008-3256. Epub 2010 Jun 21.

  • Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.

  • Gavine A, Shinwell SC, Buchanan P, Farre A, Wade A, Lynn F, Marshall J, Cumming SE, Dare S, McFadden A. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2022 Oct 25;10(10):CD001141. doi: 10.1002/14651858.CD001141.pub6.

Related Links

MeSH Terms

Conditions

Breast FeedingNegotiating

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorCommunication

Study Officials

  • Célia BASURKO, MD

    Centre Hospitalier de Cayenne

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2026

First Posted

September 8, 2026

Study Start

May 26, 2026

Primary Completion (Estimated)

May 31, 2029

Study Completion (Estimated)

May 31, 2029

Last Updated

September 8, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations