Weight Changes Among Martinican Prisoners (NUTRI-LAJÔL)

February 20, 2025 updated by: University Hospital Center of Martinique
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Several studies described how weight of prisoners may vary during incarceration. Taking or losing weight both have health consequences but are also a warning signal for several pathologies. Female prisoners are more likely getting fat, data are rare and contradictory about male prisoners. A single study was conducted in mainland France and including few men. Furthermore, Martinique is a department where the prevalence of overweight and diabetes in the general population are higher than the national average. Prisoners most often have socio-demographic featuring and morbidity different from the general population (more men, some over-represented age groups, addictive behaviors and more frequent mental health problems ...). Aspects nutritional information is less often documented. What about the weight variation of people held in Martinique? Is incarceration always accompanied by weight gain? What are factors associated with weight variation? This study aims to answer to those questions by including all men newly admit in the only martinican jail aged from 18 to 44 years and consenting. During admission medical consultation, prisoners will fill guided by the investigator doctor of self-questionnaires of the evaluation of the level of physical activity, assessment of nutritional intakes and psychological state before incarceration. Measurement of weight and other anthropometrics data will be done, investigator doctor will collect data about socio-economic featuring, medical history and treatment. Three months later, a research technician will interview included prisoners in their life place and guide them to fill new self-questionnaires of the evaluation of the level of physical activity, assessment of nutritional intakes and psychological state during incarceration. Measure weight and other anthropometrics data and collecting data about new treatment, stopping tobacco will be done during this interview.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
227

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Martinique
      • Ducos, Martinique, 97224
        • Recruiting
        • CHU Martinique
        • Contact:
        • Contact:
          • Anaïs BOURGUIGNON D'HERBIGNY, MD
        • Contact:
          • Sylvie ABEL, MD
        • Contact:
          • Armelle JEAN-ETIENNE, MD
        • Contact:
          • Sarah CHALONO, MD
        • Contact:
          • Hélène FIZE, MD
        • Contact:
          • Aurélien LEBEC, MD
        • Contact:
          • Samuel PEREAU, MD
        • Contact:
          • Luisa CARNINO, MD
        • Contact:
          • Alexia DAMIENS, MD
        • Contact:
          • Fanny QUENARD, MD
        • Contact:
          • Matthieu PONSOYE, MD
        • Contact:
          • Romain MORTIER, MD
        • Contact:
          • Gabriel LAVAYSSIERE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • all men newly incarcerated in martinican jail during inclusion period
  • age between 18 and 44 years old
  • having given his consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight change between baseline and Month 3 visit among men aged 18 to 44, newly incarcerated in martinican jail
Time Frame: The primary outcome will be collected at baseline (entrance medical examination) and Month 3 visit
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body mass index measurement change between baseline and Month 3 visit
Time Frame: This outcome will be collected at baseline (entrance medical examination) and Month 3 visit
BMI in kg/m^2
This outcome will be collected at baseline (entrance medical examination) and Month 3 visit
Waist size measurement change between baseline and Month 3 visit
Time Frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
Waist size in centimeters
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
Time Frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
Lean body mass is measured with a body composition scale in kg
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
Time Frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
Body fat is measured with a body composition scale in percentage
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
Time Frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
Percentage body water is measured with a body composition scale
This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
Visceral fat measurement change between baseline and Month 3 visit
Time Frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
Visceral fat is measured with a body composition scale in level
This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
Basal metabolic rate measurement change between baseline and Month 3 visit
Time Frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
Basal metabolic rate is measured with a body composition scale in kCal
This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
Sportive activities intensity change can be associated with weight change between baseline and Month 3 visit
Time Frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
Change in intensity of sports activities measured using a self-questionnaire according to RICCI & GAGNON
This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
The variation of nutrition intakes change can be associated with weight change between baseline and Month 3 visit
Time Frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
The variation in nutritional intake is assessed by means of a questionnaire
This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
Psychological state change can be associated with weight change between baseline and Month 3 visit
Time Frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
Change in psychological state will be assessed by the STAY self-questionnaire
This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
New treatment can be associated with weight change between baseline and Month 3 visit
Time Frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
Introduction or not of new treatment that may have an impact on the weight per data collection. Name of new treatment (in case of) will be notifed in order to search if weigth change is one of his sides effect known.
This outcome will be collected at baseline (entrance medical examination) and visit at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Center of Martinique

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anaïs BOURGUIGNON D'HERBIGNY, MD, Martinique University Hospital Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19_RIPH3_13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings