Weight Changes Among Martinican Prisoners (NUTRI-LAJÔL)

October 16, 2023 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

Recruiting

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 Locations

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

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

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

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.

Investigators

  • 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)

January 11, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

November 14, 2022

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19_RIPH3_13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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