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NCT Number: NCT06528535

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

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

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Centre Hospitalier de Cayenne

Cayenne, 97300, French Guiana

Location status: Recruiting

Location contact

Celia BASURKO, MD

CONTACT

[email protected]

+594 5 94 39 57 66

Emeline MONTJARDE, Midwife

PRINCIPAL_INVESTIGATOR

Jean-Daniel HINI, MD

PRINCIPAL_INVESTIGATOR

Lindsay OSEI, MD

PRINCIPAL_INVESTIGATOR

Mathieu NACHER, PhD

CONTACT

[email protected]

+594 5 94 39 53 85

Nfassory CAMARA, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health promotion intervention

Other

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

Primary outcomes

  1. Description of diet during pregancy

    Time frame: At inclusion

    To describe the diet of pregnant women among women who benefited from the health promotion intervention and those who didn't from a questionnaire

Secondary outcomes

  1. Prevalence of food insecurity

    Time frame: At inclusion

    To estimate food insecurity of pregnant women monitored in PMI using the Minimum Dietary Diversity for Women (MDD-W) score

  2. Description of socio-demographic characteristics of participants

    Time frame: At inclusion

    To compare the socio-demographic characteristics of pregnant women who benefited from the intervention with those who didn't

  3. Description of pregnancy outcomes

    Time frame: At inclusion

    To 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

  4. Description of immediate post-partum outcomes

    Time frame: At inclusion

    To 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

  5. Concentration of micronutrients

    Time frame: At inclusion

    To measure concentration of micronutrients (iron, iodine, zinc, magnesium, vitamins...) of pregnant women

  6. Concentration of heavy metal

    Time frame: At inclusion

    To measure concentration of heavy metal (mercury, lead) of pregnant women

  7. Description of self-esteem

    Time frame: At inclusion

    To describe the self-esteem of pregnant women using the Rosenberg self esteem questionnaire

  8. Description of knowledge of pregnant women on diet

    Time frame: At inclusion

    To describe the level of knowledge on diet of pregant women who benefited from the helath promotion intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Celia BASURKO, MD

CONTACT

[email protected]

+594 5 94 39 57 66

Mathieu NACHER, PhD

CONTACT

[email protected]

+594 5 94 39 53 85

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Cayenne

Other

Registry information

Acronym: NPTM2

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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