Weight GainNUTRI-LAJÔLNCT05982132
Weight Changes Among Martinican Prisoners
An observational study of Weight Gain and Weight Loss, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Gain, Weight Loss
- What is being tested?
- anthropometric measurement
- How many people
- 227 participants
- Where
- 1 siteMartinique
- Study dates
- 11 Jan 2023to Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: all men aged from 18 to 44 incarcerated in martinican jail during inclusion period and consenting
Who may be able to join
- all men newly incarcerated in martinican jail during inclusion period
- age between 18 and 44 years old
- having given his consent
Who cannot join
- female
- 44 years old and up
- not understanding or speaking French or English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Martinique1 site, 1 recruiting
- Recruiting
CHU Martinique
Ducos, 97224
Anaïs BOURGUIGNON D'HERBIGNY, anais.bourguignon@chu-martinique.fr
Anaïs BOURGUIGNON D'HERBIGNY, MD
About this study
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.
Read the 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.
- Conditions
- Weight Gain, Weight Loss
- Being tested
- anthropometric measurement
- Keywords
- Prisoners, Body weight, Male, French West Indies, Epidemiology
- Medical subject headings
- Weight Gain, Weight Loss, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anthropometric measurementOther
Measurement of weight and other anthropometrics data
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
BMI in kg/m^2
Measured: This outcome will be collected at baseline (entrance medical examination) and Month 3 visit
Waist size measurement change between baseline and Month 3 visit
Waist size in centimeters
Measured: 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
Lean body mass is measured with a body composition scale in kg
Measured: 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
Body fat is measured with a body composition scale in percentage
Measured: 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
Percentage body water is measured with a body composition scale
Measured: 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
Visceral fat is measured with a body composition scale in level
Measured: 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
Basal metabolic rate is measured with a body composition scale in kCal
Measured: 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
Change in intensity of sports activities measured using a self-questionnaire according to RICCI \& GAGNON
Measured: 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
The variation in nutritional intake is assessed by means of a questionnaire
Measured: 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
Change in psychological state will be assessed by the STAY self-questionnaire
Measured: 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
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.
Measured: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start11 Jan 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 227 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anaïs BOURGUIGNON D'HERBIGNY, MD, Principal investigator, Martinique University Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982132
- Sponsor's protocol ID
- 19_RIPH3_13
- Acronym
- NUTRI-LAJÔL
- Status last verified
- Feb 2025
- First submitted
- 14 Nov 2022
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Changes Among Martinican Prisoners
- ClinicalTrials.gov ID
- NCT05982132
- Acronym / sponsor ID
- NUTRI-LAJÔL / 19_RIPH3_13
- Conditions
- Weight Gain, Weight Loss
- Keywords
- Prisoners, Body weight, Male, French West Indies, Epidemiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 227 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- all men aged from 18 to 44 incarcerated in martinican jail during inclusion period and consenting
Key inclusion criteria (3 listed)
- all men newly incarcerated in martinican jail during inclusion period
- age between 18 and 44 years old
- having given his consent
Key exclusion criteria (3 listed)
- female
- 44 years old and up
- not understanding or speaking French or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anthropometric measurementMeasurement of weight and other anthropometrics data | Other | – |
Primary outcome
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
11 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anaïs BOURGUIGNON D'HERBIGNY, MD principal investigator
Martinique University Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Gain and Weight Loss, run by University Hospital Center of Martinique at 1 site in Martinique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veronique PELONDE-ERIMEE, RCA (0596592697 ext. +596, veronique.pelonde-erimee@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.