NCT06528535

Brief 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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

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 Start

First participant enrolled

September 22, 2023

Completed
10 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
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

July 23, 2024

Last Update Submit

July 31, 2024

Conditions

Keywords

French GuianaPregnancyFood safetyHealth promotionNutrition

Outcome Measures

Primary Outcomes (1)

  • 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

    At inclusion

Secondary Outcomes (8)

  • Prevalence of food insecurity

    At inclusion

  • Description of socio-demographic characteristics of participants

    At inclusion

  • Description of pregnancy outcomes

    At inclusion

  • Description of immediate post-partum outcomes

    At inclusion

  • Concentration of micronutrients

    At inclusion

  • +3 more secondary outcomes

Study Arms (2)

Group 1 - intervention

Pregant women living in French Guiana who benefited from a health promotion intervention

Other: Health promotion intervention

Group 2 - control

Pregant women living in French Guiana who did not benefit from a health promotion intervention

Interventions

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

Group 1 - intervention

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Refusal to participate to the study
  • No authorisation of participation from legal representatives for minor participants
  • Participants under guardianship or trusteeship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Cayenne

Cayenne, 97300, French Guiana

RECRUITING

Related Publications (4)

  • 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.

    PMID: 12633509BACKGROUND
  • Basu 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.

    PMID: 28384086BACKGROUND
  • Austin 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.

    PMID: 21818162BACKGROUND
  • Austin 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.

    PMID: 19684288BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, urine, serum, plasma, hair, placenta

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

September 22, 2023

Primary Completion

March 1, 2025

Study Completion

September 1, 2025

Last Updated

August 1, 2024

Record last verified: 2024-07

Locations