Food InsecurityNutriPouTiMounNCT05653128
Food and Nutrition Insecurity During Pregnancy in French Guiana
An observational study of Food Insecurity and Pregnancy Related, run by Centre Hospitalier de Cayenne at 3 sites in French Guiana.
Trial summary
This is a cross-sectional study of a representative sample of women who gave birth in the 3 maternity hospitals of French Guiana. The main objective is to estimate the prevalence of food insecurity among pregnant women admitted for delivery in one of the maternity hospitals of French Guiana. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity, Pregnancy Related
- How many people
- 788 participants
- Where
- 3 sitesFrench Guiana
- Study dates
- 19 Jan 2023to 11 Sep 2023
- 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: Women admitted for delivery in one of the maternity hospitals in French Guiana
Who may be able to join
- Women admitted for delivery in one of the maternity hospitals in French Guiana
Who cannot join
- refusal to participate or lack of collected non-opposition
- lack of parental consent for women under 18 years of age.
Trial locations and contacts
3 sites in 1 country.
French Guiana3 sites
Centre Hospitalier de Cayenne
Cayenne, 97300
Centre Hospitalier de Kourou
Kourou, 97380
Centre Hospitalier de l'Ouest Guyanais
Saint-Laurent-du-Maroni, 97320
About this study
This is a cross-sectional study of a representative sample of women who gave birth in the 3 maternity hospitals of French Guiana. The main objective is to estimate the prevalence of food insecurity among pregnant women admitted for delivery in one of the maternity hospitals of French Guiana. A biological assay of deficiencies and toxic metals as well as the completion of a questionnaire will answer the research question
Read the 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.
- Conditions
- Food Insecurity, Pregnancy Related
- Keywords
- French Guiana, Pregnancy, Food security, Cross-section study, Nutrition, Social inequality in health
What is being measured
The primary outcome is the main question the study is designed to answer.
Household food insecurity
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
Measured: At inclusion
Secondary outcomes (7)
Evaluation of coping strategies
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
Measured: At inclusion
Evaluation of the Food Insecurity Experience
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
Measured: At inclusion
Evaluation of the food consumption frequencies in the past 3 months
Description of the food consumption frequencies in the past 3 months using a face-to-face questionnaire
Measured: At inclusion
Evaluation of the socio-demographic profile of the household
Description of the socio-demographic profile of the household at inclusion according to food insecurity level, by face-to-face questionnaire
Measured: At inclusion
Evaluation of the economic profile of the household
Description of the economic profile of the household at inclusion according to food insecurity level, by face-to-face questionnaire
Measured: At inclusion
Evaluation of the micronutrient deficiencies
Evaluation of the micronutrient deficiencies by measuring biomarkers of nutritional status : vitamins and mineral levels, toxic metals in blood and urine
Measured: At inclusion
Evaluation of the self esteem
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
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 posted16 Dec 2022
- Study start19 Jan 2023
- Primary completion11 Sep 2023
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Food InsecurityStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 788 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Célia BASURKO, MD, Principal investigator, Centre Hospitalier de Cayenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653128
- Sponsor's protocol ID
- NutriPouTi'moun
- Acronym
- NutriPouTiMoun
- Status last verified
- Jul 2024
- First submitted
- 18 Nov 2022
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32405459Pena-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.
PubMed 26198451Aghajafari 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.
PubMed 23533188Hofmeyr 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.
PubMed 30277579Wu 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.
PubMed 15333699Richterman 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.
PubMed 32611679Moafi 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.
PubMed 30081856Augusto 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.
PubMed 32303221Khoshgoo 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.
PubMed 32426008Perez-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.
PubMed 32458574Jones 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.
PubMed 24038241
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food and Nutrition Insecurity During Pregnancy in French Guiana
- ClinicalTrials.gov ID
- NCT05653128
- Acronym / sponsor ID
- NutriPouTiMoun / NutriPouTi'moun
- Conditions
- Food Insecurity, Pregnancy Related
- Keywords
- French Guiana, Pregnancy, Food security, Cross-section study, Nutrition, Social inequality in health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 788 participants (actual)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 16 Dec 2022 (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 cross-sectional study of a representative sample of women who gave birth in the 3 maternity hospitals of French Guiana. The main objective is to estimate the prevalence of food insecurity among pregnant women admitted for delivery in one of the maternity hospitals of French Guiana. A biological assay of deficiencies and toxic metals as well as the completion of a questionnaire will answer the research question
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women admitted for delivery in one of the maternity hospitals in French Guiana
Key inclusion criteria (1 listed)
- Women admitted for delivery in one of the maternity hospitals in French Guiana
Key exclusion criteria (2 listed)
- refusal to participate or lack of collected non-opposition
- lack of parental consent for women under 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Household food insecurity
Time frame: At inclusion
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
7 secondary outcomes
Evaluation of coping strategies
Time frame: At inclusion
Evaluation of the Food Insecurity Experience
Time frame: At inclusion
Evaluation of the food consumption frequencies in the past 3 months
Time frame: At inclusion
Evaluation of the socio-demographic profile of the household
Time frame: At inclusion
Evaluation of the economic profile of the household
Time frame: At inclusion
Evaluation of the micronutrient deficiencies
Time frame: At inclusion
Evaluation of the self esteem
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Background: PubMed 32405459Roberton 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.
- Background: PubMed 26198451Pena-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.
- Background: PubMed 23533188Aghajafari 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.
- Background: PubMed 30277579Hofmeyr 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.
- Background: PubMed 15333699Wu 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.
- Background: PubMed 32611679Richterman 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.
- Background: PubMed 30081856Moafi 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.
- Background: PubMed 32303221Augusto 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.
- Background: PubMed 32426008Khoshgoo 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.
- Background: PubMed 32458574Perez-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.
- Background: PubMed 24038241Jones 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.
- Food security : information for action (practical guides). Introduction to food security conceptsLink provided by the sponsor.
- Summary of World food security status 2021Link provided by the sponsor.
- Hunger at Covid 19 times in Cayenne (French Guiana) and surroundingsLink 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.
Célia BASURKO, MD principal investigator
Centre Hospitalier de Cayenne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Insecurity and Pregnancy Related, run by Centre Hospitalier de Cayenne at 3 sites 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Household food insecurity (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 NCT05653128, which also lists 11 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 26 Jul 2024.