Infant Feeding in French Guiana (ANJE Nutri)

July 26, 2024 updated by: Centre Hospitalier de Cayenne

Food Insecurity During Pregnancy in French Guiana - Focus on Infant Feeding

This is a comparative, observal study among the population of pregant women who participated to the study "Nutri Pou Ti Moun" on food insecurity during pregnancy in French Guiana

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The international literature has already demonstrated the benefits of breastfeeding (BF) in the short, medium and long term for the health of children and mothers alike. For children, breastfeeding helps to reduce mortality from infections, prevents hospitalisations, particularly for gastroenteritis and respiratory illnesses, and prevents diabetes and childhood obesity. Breastfeeding also plays an important role in children's cognitive development, with an impact on IQ and academic success. For mothers, not breastfeeding is associated with an increased risk of breast and ovarian cancer, type II diabetes, obesity and cardiovascular disorders. Similarly, the WHO recommends optimal feeding practices for infants up to 2 years of age, i.e. early initiation of breastfeeding to allow the child to receive colostrum, exclusive BF for 4 to 6 months, and the timely introduction of liquid, semi-solid or solid foods, the continuation of BF for up to 2 years and beyond, the consumption of age-appropriate infant formula (IF) as an alternative to breastfeeding, and a minimum acceptable intake of complementary food to breast or infant milk.

On a national scale, the 'first 1000 days' initiative (from the 4th month of pregnancy to the child's 2nd birthday) that emerged at the symposium on 23 September 2021 organised by Santé Publique France and the French Ministry of Solidarity and Health includes the objective of promoting good BF practices. Similarly, the 2019-2023 national nutrition and health plan (PNNS4) aims to increase the percentage of children breastfed at birth by at least 15% and to extend the median duration of total breastfeeding by 2 weeks. In French Guyana, the 2023-2028 regional health plan points out that perinatal indicators in the French overseas territories are worse than in mainland France, and that improving mother and child health must involve improving the environment in which children live during their first 1,000 days.

In 2005, an initial retrospective study of breastfeeding practices was carried out in western part of French Guiana and showed a rate of exclusive breastfeeding at 4 months of age of 3% and a rate of continued breastfeeding of 16.7% up to 1 year and 6.5% up to 2 years. Between 2010 and 2012, a prospective survey of the whole of French Guiana found an exclusive BF rate of 27% at 1 month, 9% at 3 months and 5% at 6 months. In the Epifane survey conducted in France between 2010 and 2012, the rate of exclusive breastfeeding at 1 month and 3 months was close to that in French Guiana (28% and 10% respectively), with an average duration of exclusive or predominant breastfeeding of 3 weeks.

The rate of continued breastfeeding for up to 1 year was estimated at 16% in the Guiana study, compared with 9% in France. The rate of mixed breastfeeding concerned 30% of women breastfeeding from the maternity hospital in French Guiana, compared with 20% in France. The main reasons for introducing bottles of infant formula (IF) in both French Guiana and France were the impression of a lack of milk (the child's feeling of dissatisfaction) and the return to work. On the other hand, almost 1 in 2 women in French Guiana stated that no healthcare professional had shown any interest in their breastfeeding at 1 month post-partum.

Since January 2023, the Nutri Pou Ti'moun study ('Nutri 1 project' ID-RCB 2022-A01772-41), carried out in 3 maternity units in French Guiana and involving 800 women who have given birth - the 'Nutri 1 women's group' - aims to take stock of women's food insecurity during pregnancy and to describe the medical consequences observed on the course and outcome of pregnancy and on infant health in the immediate post-partum period. In the course of this project, the links between vitamin and mineral deficiencies, heavy metal impregnation and maternal dietary diversification are being studied. In the Guianese context of multidimensional precariousness, the Guianese perinat network, in partnership with local and institutional players, aimed to set up a health and nutrition pathway from the 4th month of pregnancy in October 2023, comprising weekly workshops co-hosted by a health mediator (on diet, well-being, adapted physical activities and the promotion of breastfeeding) and the distribution of baskets of fresh, local fruit and vegetables.

This health promotion intervention is offered to pregnant women attending the maternal and child health protection centre (PMI) in the Communauté d'agglomération du centre littoral (CACL) - the 'Nutri 2 women's group'. This intervention gave rise to an ancillary research project to the Nutri Pou Ti'moun research project, the Nutri pou ti'moun 2 project (Nutri 2 project; ID-RCB 2023-A00167-38) aimed at assessing the impact of this action on women's diet (diversity and food insecurity) by comparing the data from the Nutri 1 women's group with that from the Nutri 2 women's group. These projects only cover the period from pregnancy to the immediate post-partum period. By 31 December 2023, 786 women had been included in the Nutri 1 project and 57 women in the ancillary Nutri 2 project.

The relevance and interest of conducting research in French Guiana on breastfeeding practices and, more broadly, on infant feeding are justified:

  • On the one hand, by the absence of recent published data on infant feeding practices in French Guiana. The second national Epifane survey, to be carried out in 2021 and focusing on infant nutrition during the first year of life, is a study being conducted in parallel with the national perinatal survey in France. An extension of this survey was carried out in the French overseas departments and territories, but French Guiana was not included.
  • On the other hand, the Nutri Pou Ti Moun project represents an opportunity to collect data on infant feeding from a representative sample of women giving birth in French Guiana, in the three public maternity hospitals (Nutri 1 group of women). Medical, biomedical and socio-demographic data, as well as data relating to food safety and nutrition during pregnancy already collected during the Nutri Pou Ti moun project, will be analysed with regard to infant feeding practices and child development data (staturo-weight, cranial perimeter, psychomotor development). The impact of a prenatal intervention on nutrition could also be assessed by comparing infant feeding data for children in the Nutri 1 group and those in the Nutri 2 group.

In a socio-economic and health context that is different from that in mainland France, food insecurity in French Guiana during pregnancy, as assessed in the Nutri Pou Ti moun project, is likely to have consequences for young children that it would be relevant to measure and compare with national and international data. In the short term, the impact of this food insecurity would influence the use and duration of breastfeeding, the occurrence of anaemia in young children and dietary practices; and in the medium term, the child's staturo-weight development and cognitive development.

Study Type

Observational

Enrollment (Estimated)

380

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • French Guiana
      • Cayenne, French Guiana, 97300
        • Recruiting
        • Centre Hospitalier de Cayenne
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-Daniel HINI, MD
        • Principal Investigator:
          • Nfassory CAMARA, MD
        • Principal Investigator:
          • Lindsay OSEI, MD
        • Principal Investigator:
          • Najeh HCINI, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women living in French Guiana who participated to the Nutri Pou Ti Moun project and who benefited or not from a health promotion intervention on nutrition

Description

Inclusion Criteria:

  • Intervention group : women included in Nutri Pou Ti Moun project and who benefited from health promotion intervention
  • Control group : women included in Nutri Pou Ti Moun project and who did not benefit from health promotion intervention

Exclusion Criteria:

  • Women refusing to participate to the study
  • Women who moved out of French Guiana
  • Women lost for follow up or who could not be contacted for the participation to the study
  • Minor women who could not obtain authorisation from legal representatives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1 - control
Pregant women included in Nutri Pou Ti Moun 1 project who did not benefit from the health promotion intervention
Group 2 - intervention
Pregant women included in Nutri Pou Ti Moun 1 project who benefited from the health promotion intervention
Other: Health promotion intervention
Health promotion intervention with activites linked to nutrition, and distribution of baskets of fresh fruits and vegetables

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of exclusive breastfeeding at 3 months of age in French Guiana
Time Frame: At inclusion
To estimate the prevalence of exlusive breastfeeding at 3 months of age in French Guiana in the group control and the group intervention
At inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of exclusive breastfeeding practices
Time Frame: At inclusion
To describe exclusive breasfeeding practices by questionnaire
At inclusion
Description of artificial breastfeeding practices
Time Frame: At inclusion
To describe artificial breastfeeding practices by questionnaire
At inclusion
Description of dietary diversity in infants
Time Frame: At inclusion
To describe dietary diversity in infants by questionnaire
At inclusion
Description of the minimal dietary diversity
Time Frame: 12 months
To describe the minimal dietary diversity for children 6-23 months (MDD-IYCF) at 12 months of age by questionnaire
12 months
Description of the minimal dietary diversity of mothers
Time Frame: 12 months
To describe the minimal dietary diversity of mothers (MDD-W) at 12 months of age of the baby by questionnaire
12 months
Description of staturo-ponderal and psychomotor development indicators
Time Frame: 12 months
Prevalence of staturo-ponderal and psychomotor development indicators among infants during their 1st year of age
12 months
Breastfeeding rate, exclusive and artificial breastfeeding duration, dietary diversity between groups
Time Frame: 12 months
Comparison of breastfeeding rate, exclusive and artificial breastfeeding duration, dietary diversity and age at diversity between the 2 groups
12 months
Description of breastfeeding practices from mothers point of view
Time Frame: At inclusion
To describe views on breastfeeding practices in intervention group by semi-structured interview
At inclusion
Description of breastfeeding practices from professionals point of view
Time Frame: At inclusion
To describe views on breastfeeding practices in professionals by semi-structured interview
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Cayenne

Investigators

  • Principal Investigator: Celia BASURKO, MD, Centre Hospitalier de Cayenne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 23, 2024

First Submitted That Met QC Criteria

July 26, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 26, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ANJE Nutri

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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