Food SafetyNPTM2NCT06528535
Evaluation of a Health Promotion Intervention on Food Safety in Women During Pregnancy
An observational study of Food Safety and Pregnancy Related, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
Trial 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 Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Food Safety, Pregnancy Related, Health Promotion
- What is being tested?
- Health promotion intervention
- How many people
- 200 participants
- Where
- 1 siteFrench Guiana
- Study dates
- 22 Sep 2023to Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Refusal to participate to the study
- No authorisation of participation from legal representatives for minor participants
- Participants under guardianship or trusteeship
Trial locations and contacts
1 site in 1 country.
French Guiana1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Cayenne
Cayenne, 97300
Celia BASURKO, MD, +594 5 94 39 57 66, celia.basurko@ch-cayenne.fr
Mathieu NACHER, PhD, +594 5 94 39 53 85, mathieu.nacher@ch-cayenne.fr
About this study
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
Read the 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.
- Conditions
- Food Safety, Pregnancy Related, Health Promotion
- Being tested
- Health promotion intervention
- Keywords
- French Guiana, Pregnancy, Food safety, Health promotion, Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health promotion interventionOther
Health promotion activities on nutrition with distribution of baskets of fresh fruits and vegetables
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - intervention | Pregant women living in French Guiana who benefited from a health promotion intervention Receives: Other: Health promotion intervention | |
| Group 2 - control | Pregant women living in French Guiana who did not benefit from a health promotion intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of diet during pregancy
To describe the diet of pregnant women among women who benefited from the health promotion intervention and those who didn't from a questionnaire
Measured: At inclusion
Secondary outcomes (8)
Prevalence of food insecurity
To estimate food insecurity of pregnant women monitored in PMI using the Minimum Dietary Diversity for Women (MDD-W) score
Measured: At inclusion
Description of socio-demographic characteristics of participants
To compare the socio-demographic characteristics of pregnant women who benefited from the intervention with those who didn't
Measured: At inclusion
Description of pregnancy outcomes
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
Measured: At inclusion
Description of immediate post-partum outcomes
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
Measured: At inclusion
Concentration of micronutrients
To measure concentration of micronutrients (iron, iodine, zinc, magnesium, vitamins...) of pregnant women
Measured: At inclusion
Concentration of heavy metal
To measure concentration of heavy metal (mercury, lead) of pregnant women
Measured: At inclusion
Description of self-esteem
To describe the self-esteem of pregnant women using the Rosenberg self esteem questionnaire
Measured: At inclusion
Description of knowledge of pregnant women on diet
To describe the level of knowledge on diet of pregant women who benefited from the helath promotion intervention
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start22 Sep 2023
- Primary completionMar 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Food SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Celia BASURKO, MD, Principal investigator, Centre Hospitalier de Cayenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528535
- Sponsor's protocol ID
- NutriPouTiMoun2
- Acronym
- NPTM2
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Radimer KL, Radimer KL. Measurement of household food security in the USA and other industrialised countries. Public Health Nutr. 2002 Dec;5(6A):859-64. doi: 10.1079/PHN2002385.
PubMed 12633509Basu S, Meghani A, Siddiqi A. Evaluating the Health Impact of Large-Scale Public Policy Changes: Classical and Novel Approaches. Annu Rev Public Health. 2017 Mar 20;38:351-370. doi: 10.1146/annurev-publhealth-031816-044208.
PubMed 28384086Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8.
PubMed 21818162Austin 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.
PubMed 19684288Galindo MS, Gatti C, Dupart O, Debruyker A, Thomas N, Nacher M, Basurko C. Implementation fidelity of a pilot group-based nutrition intervention for pregnant women (Nutri Pou Ti' Moun 2): a mixed methods assessment. BMC Public Health. 2026 Jul 17. doi: 10.1186/s12889-026-28456-0. Online ahead of print.
PubMed 42469759
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Health Promotion Intervention on Food Safety in Women During Pregnancy
- ClinicalTrials.gov ID
- NCT06528535
- Acronym / sponsor ID
- NPTM2 / NutriPouTiMoun2
- Conditions
- Food Safety, Pregnancy Related, Health Promotion
- Keywords
- French Guiana, Pregnancy, Food safety, Health promotion, Nutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - intervention | – | Other: Health promotion interventionPregant women living in French Guiana who benefited from a health promotion intervention |
| Group 2 - control | – | –Pregant women living in French Guiana who did not benefit from a health promotion intervention |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Refusal to participate to the study
- No authorisation of participation from legal representatives for minor participants
- Participants under guardianship or trusteeship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health promotion interventionHealth promotion activities on nutrition with distribution of baskets of fresh fruits and vegetables | Other | Group 1 - intervention |
Primary outcome
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
8 secondary outcomes
Prevalence of food insecurity
Time frame: At inclusion
Description of socio-demographic characteristics of participants
Time frame: At inclusion
Description of pregnancy outcomes
Time frame: At inclusion
Description of immediate post-partum outcomes
Time frame: At inclusion
Concentration of micronutrients
Time frame: At inclusion
Concentration of heavy metal
Time frame: At inclusion
Description of self-esteem
Time frame: At inclusion
Description of knowledge of pregnant women on diet
Time frame: At inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Background: PubMed 12633509Radimer KL, Radimer KL. Measurement of household food security in the USA and other industrialised countries. Public Health Nutr. 2002 Dec;5(6A):859-64. doi: 10.1079/PHN2002385.
- Background: PubMed 28384086Basu S, Meghani A, Siddiqi A. Evaluating the Health Impact of Large-Scale Public Policy Changes: Classical and Novel Approaches. Annu Rev Public Health. 2017 Mar 20;38:351-370. doi: 10.1146/annurev-publhealth-031816-044208.
- Background: PubMed 21818162Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8.
- Background: PubMed 19684288Austin 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.
- Derived from this study: PubMed 42469759Galindo MS, Gatti C, Dupart O, Debruyker A, Thomas N, Nacher M, Basurko C. Implementation fidelity of a pilot group-based nutrition intervention for pregnant women (Nutri Pou Ti' Moun 2): a mixed methods assessment. BMC Public Health. 2026 Jul 17. doi: 10.1186/s12889-026-28456-0. Online ahead of print.
- Global health in French Guiana : descriptive and comparative study of main health indicatorsLink provided by the sponsor.
- Mother and child prevention in French Guiana : coping solutions in response to deteriorating living conditions of local populationsLink provided by the sponsor.
- Society and the adolescent senf-imageLink provided by the sponsor.
- Heavy metal impregnations in French population. Biosurveillance national program Esteban 2014-2016Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celia BASURKO, MD principal investigator
Centre Hospitalier de Cayenne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Safety and Pregnancy Related, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in French Guiana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Celia BASURKO, MD (+594 5 94 39 57 66, celia.basurko@ch-cayenne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of diet during pregancy (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06528535, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.