Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528275
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Infant Feeding in French Guiana
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Food Insecurity During Pregnancy in French Guiana - Focus on Infant Feeding
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANJE Nutri
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 childrens 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 ie 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 childs 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 1000 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 167 up to 1 year and 65 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 childs 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 Timoun 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 womens group - aims to take stock of womens 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 dagglomération du centre littoral CACL - the Nutri 2 womens group This intervention gave rise to an ancillary research project to the Nutri Pou Timoun research project the Nutri pou timoun 2 project Nutri 2 project ID-RCB 2023-A00167-38 aimed at assessing the impact of this action on womens diet diversity and food insecurity by comparing the data from the Nutri 1 womens group with that from the Nutri 2 womens 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 childs staturo-weight development and cognitive development
On a national scale the first 1000 days initiative from the 4th month of pregnancy to the childs 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 1000 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 167 up to 1 year and 65 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 childs 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 Timoun 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 womens group - aims to take stock of womens 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 dagglomération du centre littoral CACL - the Nutri 2 womens group This intervention gave rise to an ancillary research project to the Nutri Pou Timoun research project the Nutri pou timoun 2 project Nutri 2 project ID-RCB 2023-A00167-38 aimed at assessing the impact of this action on womens diet diversity and food insecurity by comparing the data from the Nutri 1 womens group with that from the Nutri 2 womens 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 childs staturo-weight development and cognitive development
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None