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Evaluation of a Health Promotion Intervention on Food Safety in Women During Pregnancy

Evaluation of a Health Promotion Intervention on Food Safety in Women During Pregnancy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06528535
Acronym
NPTM2
Enrollment
200
Registered
2024-07-30
Start date
2023-09-22
Completion date
2025-09-30
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Safety, Health Promotion, Pregnancy Related

Keywords

French Guiana, Pregnancy, Food safety, Health promotion, 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.

Interventions

Health promotion activities on nutrition with distribution of baskets of fresh fruits and vegetables

Sponsors

Centre Hospitalier de Cayenne
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Description of diet during pregancyAt inclusionTo describe the diet of pregnant women among women who benefited from the health promotion intervention and those who didn't from a questionnaire

Secondary

MeasureTime frameDescription
Description of socio-demographic characteristics of participantsAt inclusionTo compare the socio-demographic characteristics of pregnant women who benefited from the intervention with those who didn't
Description of pregnancy outcomesAt inclusionTo describe pregnancy outcomes (gestational diabetis, foetal cardiac rhythm abnormalities, pre-eclampsia/eclampsia, foetal weight abnormalities) of pregnant women who benefited from the intervention with those who didn't, documented from medical file
Description of immediate post-partum outcomesAt inclusionTo describe immediate post-partum outcomes (vaginal delivery, C-section, post partum bleeding) of pregnant women who benefited from the intervention with those who didn't, documented from medical file
Prevalence of food insecurityAt inclusionTo estimate food insecurity of pregnant women monitored in PMI using the Minimum Dietary Diversity for Women (MDD-W) score
Concentration of heavy metalAt inclusionTo measure concentration of heavy metal (mercury, lead) of pregnant women
Description of self-esteemAt inclusionTo describe the self-esteem of pregnant women using the Rosenberg self esteem questionnaire
Description of knowledge of pregnant women on dietAt inclusionTo describe the level of knowledge on diet of pregant women who benefited from the helath promotion intervention
Concentration of micronutrientsAt inclusionTo measure concentration of micronutrients (iron, iodine, zinc, magnesium, vitamins...) of pregnant women

Countries

French Guiana

Contacts

Primary ContactCelia BASURKO, MD
celia.basurko@ch-cayenne.fr+594 5 94 39 57 66
Backup ContactMathieu NACHER, PhD
mathieu.nacher@ch-cayenne.fr+594 5 94 39 53 85

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 19, 2026