NCT06528275

Brief Summary

This is a comparative, observal study among the population of pregant women who participated to the study "Nutri Pou Ti Moun" on food insecurity during pregnancy in French Guiana

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Mar 2024Aug 2026

Study Start

First participant enrolled

March 14, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

July 23, 2024

Last Update Submit

July 26, 2024

Conditions

Keywords

Infant feedingBreastfeedingFood insecurityPregnancyFrench Guiana

Outcome Measures

Primary Outcomes (1)

  • Prevalence of exclusive breastfeeding at 3 months of age in French Guiana

    To estimate the prevalence of exlusive breastfeeding at 3 months of age in French Guiana in the group control and the group intervention

    At inclusion

Secondary Outcomes (9)

  • Description of exclusive breastfeeding practices

    At inclusion

  • Description of artificial breastfeeding practices

    At inclusion

  • Description of dietary diversity in infants

    At inclusion

  • Description of the minimal dietary diversity

    12 months

  • Description of the minimal dietary diversity of mothers

    12 months

  • +4 more secondary outcomes

Study Arms (2)

Group 1 - control

Pregant women included in Nutri Pou Ti Moun 1 project who did not benefit from the health promotion intervention

Group 2 - intervention

Pregant women included in Nutri Pou Ti Moun 1 project who benefited from the health promotion intervention

Other: Health promotion intervention

Interventions

Health promotion intervention with activites linked to nutrition, and distribution of baskets of fresh fruits and vegetables

Group 2 - intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women living in French Guiana who participated to the Nutri Pou Ti Moun project and who benefited or not from a health promotion intervention on nutrition

You may qualify if:

  • Intervention group : women included in Nutri Pou Ti Moun project and who benefited from health promotion intervention
  • Control group : women included in Nutri Pou Ti Moun project and who did not benefit from health promotion intervention

You may not qualify if:

  • Women refusing to participate to the study
  • Women who moved out of French Guiana
  • Women lost for follow up or who could not be contacted for the participation to the study
  • Minor women who could not obtain authorisation from legal representatives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Cayenne

Cayenne, 97300, French Guiana

RECRUITING

Related Publications (7)

  • Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.

    PMID: 26869575BACKGROUND
  • Sankar MJ, Sinha B, Chowdhury R, Bhandari N, Taneja S, Martines J, Bahl R. Optimal breastfeeding practices and infant and child mortality: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):3-13. doi: 10.1111/apa.13147.

    PMID: 26249674BACKGROUND
  • Horta BL, Loret de Mola C, Victora CG. Long-term consequences of breastfeeding on cholesterol, obesity, systolic blood pressure and type 2 diabetes: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):30-7. doi: 10.1111/apa.13133.

    PMID: 26192560BACKGROUND
  • Binns C, Lee M, Low WY. The Long-Term Public Health Benefits of Breastfeeding. Asia Pac J Public Health. 2016 Jan;28(1):7-14. doi: 10.1177/1010539515624964.

    PMID: 26792873BACKGROUND
  • Chowdhury R, Sinha B, Sankar MJ, Taneja S, Bhandari N, Rollins N, Bahl R, Martines J. Breastfeeding and maternal health outcomes: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):96-113. doi: 10.1111/apa.13102.

    PMID: 26172878BACKGROUND
  • Basurko C, Dupart O, Savy M, Obert-Marby C, Mvogo A, Gonzalez A, Trepont A, Cann L, Boceno C, Osei L, Creton PM, Dufit V, Thelusme L, Adenis A, Van-Melle A, Huber F, Nacher M. Hunger in French Guiana's Vulnerable Urban Neighborhoods: A Neglected Consequence of COVID-19. Food Nutr Bull. 2023 Mar;44(1):3-11. doi: 10.1177/03795721231156641. Epub 2023 Feb 23.

    PMID: 36824041BACKGROUND
  • Nacher M, Basurko C, Muhigirwa GB, Lambert V, Osei L, Njuieyon F, Louis A, Dotou D, Thomas N, Bernard S, Leneuve M, Elenga N, Hcini N. Infant mortality in French Guiana between 2001 and 2017 : Trends and comparisons with mainland France. Rev Epidemiol Sante Publique. 2023 Dec;71(6):102175. doi: 10.1016/j.respe.2023.102175. Epub 2023 Oct 31.

    PMID: 37918040BACKGROUND

Related Links

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Celia BASURKO, MD

    Centre Hospitalier de Cayenne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2024

First Posted

July 30, 2024

Study Start

March 14, 2024

Primary Completion

March 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

July 30, 2024

Record last verified: 2024-07

Locations