NCT05982132

Brief Summary

Assessment of body weight change among prisoners in Martinique between admission in jail and 3 months later expressed as a percentage of admission weight. Intensity of physical activities, nutrition intakes and psychological state are also studied to describe associated factors to body weight change.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
227

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 11, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

2.6 years

First QC Date

November 14, 2022

Last Update Submit

February 20, 2025

Conditions

Weight GainWeight Loss

Keywords

PrisonersBody weightMaleFrench West IndiesEpidemiology

Outcome Measures

Primary Outcomes (1)

  • Weight change between baseline and Month 3 visit among men aged 18 to 44, newly incarcerated in martinican jail

    Weight change between baseline and Month 3 visit expressed as a percentage

    The primary outcome will be collected at baseline (entrance medical examination) and Month 3 visit

Secondary Outcomes (11)

  • Body mass index measurement change between baseline and Month 3 visit

    This outcome will be collected at baseline (entrance medical examination) and Month 3 visit

  • Waist size measurement change between baseline and Month 3 visit

    This outcome will be collected at baseline (entrance medical examination) and visit at 3 months

  • Lean mass measurement change between baseline and Month 3 visit

    This outcome will be collected at baseline (entrance medical examination) and visit at 3 months

  • Body fat measurement change between baseline and Month 3 visit

    This outcome will be collected at baseline (entrance medical examination) and visit at 3 months

  • Percentage body water measurement change between baseline and Month 3 visit

    This outcome will be collected at baseline (entrance medical examination) and visit at 3 months

  • +6 more secondary outcomes

Interventions

anthropometric measurementOTHER

Measurement of weight and other anthropometrics data

Eligibility Criteria

Age18 Years - 44 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsEligibility is based on gender : only men
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

all men aged from 18 to 44 incarcerated in martinican jail during inclusion period and consenting

You may qualify if:

  • age between 18 and 44 years old
  • having given his consent

You may not qualify if:

  • female
  • years old and up
  • not understanding or speaking French or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Martinique

Ducos, 97224, Martinique

RECRUITING

MeSH Terms

Conditions

Weight GainWeight LossBody Weight

Condition Hierarchy (Ancestors)

Body Weight ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anaïs BOURGUIGNON D'HERBIGNY, MD

    Martinique University Hospital Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronique PELONDE-ERIMEE, RCA

CONTACT

0596592697veronique.pelonde-erimee@chu-martinique.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2022

First Posted

August 8, 2023

Study Start

January 11, 2023

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

MA(1)