Clinical trial NCT06528275: Infant Feeding in French Guiana
Official title: Food Insecurity During Pregnancy in French Guiana - Focus on Infant Feeding
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Food Insecurity
Pregnancy Related
Keywords: Infant feeding
Breastfeeding
Food insecurity
Pregnancy
French Guiana
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 380
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of exclusive breastfeeding at 3 months of age in French Guiana
timeFrame: At inclusion
Secondary outcomes:
measure: Description of exclusive breastfeeding practices
timeFrame: At inclusion
measure: Description of artificial breastfeeding practices
timeFrame: At inclusion
measure: Description of dietary diversity in infants
timeFrame: At inclusion
measure: Description of the minimal dietary diversity
timeFrame: 12 months
measure: Description of the minimal dietary diversity of mothers
timeFrame: 12 months
measure: Description of staturo-ponderal and psychomotor development indicators
timeFrame: 12 months
measure: Breastfeeding rate, exclusive and artificial breastfeeding duration, dietary diversity between groups
timeFrame: 12 months
measure: Description of breastfeeding practices from mothers point of view
timeFrame: At inclusion
measure: Description of breastfeeding practices from professionals point of view
timeFrame: At inclusion
Other outcomes:
Locations:
city: Cayenne
country: French Guiana
facility: Centre Hospitalier de Cayenne
Study officials:
affiliation: Centre Hospitalier de Cayenne
name: Celia BASURKO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sankar MJ, Sinha B, Chowdhury R, Bhandari N, Taneja S, Martines J, Bahl R. Optimal breastfeeding practices and infant and child mortality: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):3-13. doi: 10.1111/apa.13147.
citation: Horta BL, Loret de Mola C, Victora CG. Long-term consequences of breastfeeding on cholesterol, obesity, systolic blood pressure and type 2 diabetes: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):30-7. doi: 10.1111/apa.13133.
citation: Binns C, Lee M, Low WY. The Long-Term Public Health Benefits of Breastfeeding. Asia Pac J Public Health. 2016 Jan;28(1):7-14. doi: 10.1177/1010539515624964.
citation: Chowdhury R, Sinha B, Sankar MJ, Taneja S, Bhandari N, Rollins N, Bahl R, Martines J. Breastfeeding and maternal health outcomes: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):96-113. doi: 10.1111/apa.13102.
citation: Basurko C, Dupart O, Savy M, Obert-Marby C, Mvogo A, Gonzalez A, Trepont A, Cann L, Boceno C, Osei L, Creton PM, Dufit V, Thelusme L, Adenis A, Van-Melle A, Huber F, Nacher M. Hunger in French Guiana's Vulnerable Urban Neighborhoods: A Neglected Consequence of COVID-19. Food Nutr Bull. 2023 Mar;44(1):3-11. doi: 10.1177/03795721231156641. Epub 2023 Feb 23.
citation: Nacher M, Basurko C, Muhigirwa GB, Lambert V, Osei L, Njuieyon F, Louis A, Dotou D, Thomas N, Bernard S, Leneuve M, Elenga N, Hcini N. Infant mortality in French Guiana between 2001 and 2017 : Trends and comparisons with mainland France. Rev Epidemiol Sante Publique. 2023 Dec;71(6):102175. doi: 10.1016/j.respe.2023.102175. Epub 2023 Oct 31.