- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05653128
Food and Nutrition Insecurity During Pregnancy in French Guiana (NutriPouTiMoun)
Study Overview
Status
Conditions
Detailed Description
According to the FAO, the gender gap in the prevalence of moderate and severe food insecurity widened in the year of the pandemic, with the prevalence of food insecurity among women 10% higher than among men. Scientific projections have estimated that the increased prevalence of wasting with the pandemic in low- and middle-income countries would result in 18-23% more deaths among children. Worst-case scenarios predict an increase of 8.3 to 38.6% in maternal deaths per month in low- and middle-income countries.
The systemic nature of food insecurity among pregnant women underlines the need to address it in a comprehensive and cross-cutting manner. It seems relevant to consider it as a major determinant of the health of populations that closely follows and feeds other health determinants (precariousness, low standard of living, housing conditions, etc.) or other health consequences (pregnancy monitoring, quality of life, deficiencies, body weight, etc.).
The quality of life would be affected with an increase in stress, anxiety and depression. The link between malnutrition and household food insecurity has already been suggested. Iron deficiency anaemia was significantly associated with food insecurity in the pregnant woman's household; it also predisposes to the risk of anaemia in children under 5. According to the WHO, anaemia is a major public health problem worldwide. It affects 40% of pregnant women, with a risk of irreversible effects on the child's brain development. According to longitudinal studies, the risk of premature delivery seemed to be more frequent when the pregnant woman was in a situation of food insecurity. A diet deficient in essential micronutrients is also thought to increase the risk of low birth weight, according to studies conducted on the African continent.
In Guiana between 2019 and 2020, the CARMA study measured micronutrient deficiencies (Iodine, Iron, Zinc, Vitamin A, folic acid, Vitamin 12) in women at the time of their delivery in Cayenne. This study revealed a high prevalence of micronutrient deficiencies with 81% of parturients having at least 1 deficiency and 46% having at least 2 deficiencies. The authors suggest that the negative impact of heavy metal impregnation is a factor that aggravates deficiencies.
This research takes a global approach to the problem of food security and does not focus on one type of nutritional deficiency or on a pregnancy-related pathology. The idea is to study the links, aggravating effects and interactions between access to food, situations of precariousness, deficiencies, lead or mercury intoxication and the impact with pathologies. This strategy is based on the hypothesis that there are permanent interactions between minerals, vitamins and heavy metals and that their impact on the health of the pregnant woman and the newborn is conditioned by these interactions and by the maternal and family background.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cayenne, French Guiana, 97300
- Centre Hospitalier de Cayenne
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Kourou, French Guiana, 97380
- Centre Hospitalier de Kourou
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Saint-Laurent-du-Maroni, French Guiana, 97320
- Centre Hospitalier de l'Ouest Guyanais
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women admitted for delivery in one of the maternity hospitals in French Guiana
Exclusion Criteria:
- refusal to participate or lack of collected non-opposition
- lack of parental consent for women under 18 years of age.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Household food insecurity
Time Frame: At inclusion
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The primary measure of household food security was conducted using the Household Food Security Scale (HFSSM) validated by the United States Department of Agriculture (USDA) at inclusion
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At inclusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Evaluation of coping strategies
Time Frame: At inclusion
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Description of the coping strategies using the Coping Strategies Index (CSI) in the past 3 months The Coping Strategy Index (CSI) is an indicator of a household's food security assessing the extent to which households use harmful coping strategies when they do not have enough food or enough money to buy food.
The result is reported by a numeric score
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At inclusion
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Evaluation of the Food Insecurity Experience
Time Frame: At inclusion
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Description of the food insecurity experience using the Food Insecurity Experience Scale (FIES) in the past 3 months The FIES-SM questions refer to the experiences of the individual respondent or of the respondent's household as a whole.
The questions focus on self-reported food-related behaviors and experiences associated with increasing difficulties in accessing food due to resource constraints
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At inclusion
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Evaluation of the food consumption frequencies in the past 3 months
Time Frame: At inclusion
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Description of the food consumption frequencies in the past 3 months using a face-to-face questionnaire
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At inclusion
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Evaluation of the socio-demographic profile of the household
Time Frame: At inclusion
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Description of the socio-demographic profile of the household at inclusion according to food insecurity level, by face-to-face questionnaire
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At inclusion
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Evaluation of the economic profile of the household
Time Frame: At inclusion
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Description of the economic profile of the household at inclusion according to food insecurity level, by face-to-face questionnaire
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At inclusion
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Evaluation of the micronutrient deficiencies
Time Frame: At inclusion
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Evaluation of the micronutrient deficiencies by measuring biomarkers of nutritional status : vitamins and mineral levels, toxic metals in blood and urine
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At inclusion
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Evaluation of the self esteem
Time Frame: At inclusion
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Description of the self esteem using the Rosenberg Self-Esteem scale by a face-to-face questionnaire The scale ranges from 0-30, with 30 indicating the highest score possible Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem
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At inclusion
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Celia BASURKO, MD, Centre Hospitalier de Cayenne
Publications and helpful links
General Publications
- Pena-Rosas JP, De-Regil LM, Garcia-Casal MN, Dowswell T. Daily oral iron supplementation during pregnancy. Cochrane Database Syst Rev. 2015 Jul 22;2015(7):CD004736. doi: 10.1002/14651858.CD004736.pub5.
- Roberton T, Carter ED, Chou VB, Stegmuller AR, Jackson BD, Tam Y, Sawadogo-Lewis T, Walker N. Early estimates of the indirect effects of the COVID-19 pandemic on maternal and child mortality in low-income and middle-income countries: a modelling study. Lancet Glob Health. 2020 Jul;8(7):e901-e908. doi: 10.1016/S2214-109X(20)30229-1. Epub 2020 May 12.
- Aghajafari F, Nagulesapillai T, Ronksley PE, Tough SC, O'Beirne M, Rabi DM. Association between maternal serum 25-hydroxyvitamin D level and pregnancy and neonatal outcomes: systematic review and meta-analysis of observational studies. BMJ. 2013 Mar 26;346:f1169. doi: 10.1136/bmj.f1169.
- Hofmeyr GJ, Lawrie TA, Atallah AN, Torloni MR. Calcium supplementation during pregnancy for preventing hypertensive disorders and related problems. Cochrane Database Syst Rev. 2018 Oct 1;10(10):CD001059. doi: 10.1002/14651858.CD001059.pub5.
- Wu G, Bazer FW, Cudd TA, Meininger CJ, Spencer TE. Maternal nutrition and fetal development. J Nutr. 2004 Sep;134(9):2169-72. doi: 10.1093/jn/134.9.2169.
- Richterman A, Raymonville M, Hossain A, Millien C, Joseph JP, Jerome G, Franke MF, Ivers LC. Food insecurity as a risk factor for preterm birth: a prospective facility-based cohort study in rural Haiti. BMJ Glob Health. 2020 Jul;5(7):e002341. doi: 10.1136/bmjgh-2020-002341.
- Moafi F, Kazemi F, Samiei Siboni F, Alimoradi Z. The relationship between food security and quality of life among pregnant women. BMC Pregnancy Childbirth. 2018 Aug 6;18(1):319. doi: 10.1186/s12884-018-1947-2.
- Augusto ALP, de Abreu Rodrigues AV, Domingos TB, Salles-Costa R. Household food insecurity associated with gestacional and neonatal outcomes: a systematic review. BMC Pregnancy Childbirth. 2020 Apr 17;20(1):229. doi: 10.1186/s12884-020-02917-9.
- Khoshgoo M, Eslami O, Khadem Al-Hosseini M, Shidfar F. The Relationship between Household Food Insecurity and Depressive Symptoms among Pregnant Women: A Cross Sectional Study. Iran J Psychiatry. 2020 Apr;15(2):126-133.
- Perez-Escamilla R, Cunningham K, Moran VH. COVID-19 and maternal and child food and nutrition insecurity: a complex syndemic. Matern Child Nutr. 2020 Jul;16(3):e13036. doi: 10.1111/mcn.13036.
- Jones AD, Ngure FM, Pelto G, Young SL. What are we assessing when we measure food security? A compendium and review of current metrics. Adv Nutr. 2013 Sep 1;4(5):481-505. doi: 10.3945/an.113.004119.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NutriPouTi'moun
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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