Clinical trial NCT06528535: Evaluation of a Health Promotion Intervention on Food Safety in Women During Pregnancy
Official title: Evaluation of a Health Promotion Intervention on Food Safety in Women During Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Food Safety
Pregnancy Related
Health Promotion
Keywords: French Guiana
Pregnancy
Food safety
Health promotion
Nutrition
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 200
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: Pregnant women living in French Guiana at the moment of the study, who have benefited or not from health promotion intervention on nutrition

Brief summary: This is a comparative, observational study aiming to compare the diversity of the diet during pregnancy of women who have benefited from a health promotion intervention and who have not

Detailed description: In the Nutri Pou Ti'moun 1 project on food and nutritional insecurity during pregnancy, the inclusion of pregnant women began at the end of January 2023. As of 24 July 2023, 625 pregnant women had been included in the study. The main aim of this study is to estimate the prevalence of household food insecurity among pregnant women admitted for childbirth in one of Guyana's maternity units. Of the women included in this project, 13% were being monitored by one of French Guiana's mother and child protection centres (PMI).

In order to improve pregnancy monitoring for women and adapt to the specific characteristics of the region, the range of antenatal care services is diversified and complementary. For example, the PMI centres mainly monitor pregnant women who are not, or are no longer, entitled to social security benefits or who are affiliated to the State Medical Aid (AME) scheme, while the private sector mainly monitors women who are affiliated to one of the social security schemes. In the sub-group of women followed up by the PMI, the proportion of women in a precarious situation is therefore higher. In view of the issues raised by the Nutri Pou Ti'moun 1 project, it would seem appropriate to describe the situation of food and economic insecurity with greater statistical power in this sub-group of interest, and therefore to over-represent the women followed up by the PMI in the total sample.

The French Guiana Perinatal Network is one of the health networks defined by the law of 4 March 2002, relating to patients' rights and the quality of the health system, as follows: 'The purpose of health networks is to promote access to care, coordination, continuity or interdisciplinarity of health care provision, particularly that which is specific to certain populations, pathologies or health activities. They provide care tailored to the needs of the individual in terms of health education, prevention, diagnosis and care. They may take part in public health initiatives.

The French Guiana Perinatal Network is an association, created in 2002, whose main objective is to improve the quality of care and monitoring of pregnant women and newborn babies, as well as vulnerable children in French Guyana.

The French Guiana Perinatal Network implements a health promotion initiative on nutrition during pregnancy (between the 4th and 7th months) based on :

* Health mediation;
* Group workshops on nutrition, self-esteem, appropriate physical exercise, food budget management, breastfeeding and parenthood;
* Distribution of a basket of fresh fruit and vegetables

The patients benefiting from this intervention will be women attending one of the PMI centres taking part in the study.

These actions are likely to modify the prevalence of food insecurity among beneficiaries. Thus, it seems relevant :

* To identify, among the patients included, those who had benefited from this intervention in order to avoid introducing a bias when measuring the judgement criteria;
* To include patients followed up in the PMI centres of one of the participating centres and who had benefited from the intervention;
* To compare the prevalence of food insecurity between those who had benefited from the Réseau Périnat intervention and those who had not.

Eligibility criteria: Inclusion Criteria:

* Intervention group : Pregant women living in French Guiana during their pregancy and who benefited from the intervention
* Control group : Pregant women living in French Guiana during their pregancy and who did not benefit from the intervention

Exclusion Criteria:

* Refusal to participate to the study
* No authorisation of participation from legal representatives for minor participants
* Participants under guardianship or trusteeship

Primary outcomes:
measure: Description of diet during pregancy
timeFrame: At inclusion
Secondary outcomes:
measure: Prevalence of food insecurity
timeFrame: At inclusion
measure: Description of socio-demographic characteristics of participants
timeFrame: At inclusion
measure: Description of pregnancy outcomes
timeFrame: At inclusion
measure: Description of immediate post-partum outcomes
timeFrame: At inclusion
measure: Concentration of micronutrients
timeFrame: At inclusion
measure: Concentration of heavy metal
timeFrame: At inclusion
measure: Description of self-esteem
timeFrame: At inclusion
measure: Description of knowledge of pregnant women on diet
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:
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citation: Austin PC. The relative ability of different propensity score methods to balance measured covariates between treated and untreated subjects in observational studies. Med Decis Making. 2009 Nov-Dec;29(6):661-77. doi: 10.1177/0272989X09341755. Epub 2009 Aug 14.