- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05982132
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
Conditions
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
- Name: Veronique PELONDE-ERIMEE, RCA
- Phone Number: +596 0596592697
- Email: veronique.pelonde-erimee@chu-martinique.fr
Study Locations
-
-
-
Ducos, Martinique, 97224
- Recruiting
- CHU Martinique
-
Contact:
- Anaïs BOURGUIGNON D'HERBIGNY
- Email: anais.bourguignon@chu-martinique.fr
-
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.
Clinical Trials on Weight Loss
-
United States Army Research Institute of Environmental...USDA Grand Forks Human Nutrition Research Center; Eastern Michigan UniversityCompletedWeight Loss | Bone Loss | Muscle LossUnited States
-
Case Comprehensive Cancer CenterUniversity Hospitals Seidman Cancer CenterRecruitingUnintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking CombinUnintended Weight LossUnited States
-
Zhen Jun WangUnknownSleeve Gastrectomy | Excessive Weight Loss | Total Weight Loss | Jejunojejunal Bypass | UncutChina
-
HealthPartners InstituteNational Cancer Institute (NCI)Completed
-
Dana-Farber Cancer InstituteCompletedWeight Loss Program After Cancer DiagnosisUnited States
-
Medical University of ViennaCompleted
-
Power Life Sciences Inc.Not yet recruitingGastric Bypass | Weight Loss Surgery
-
University at BuffaloHarvard Medical School (HMS and HSDM)TerminatedWeight Loss | Appetite LossUnited States
-
Duke UniversityNational Institute on Aging (NIA)Suspended
-
Drexel UniversityUniversity of PennsylvaniaCompletedObesity | Overweight | Weight Loss MaintenanceUnited States
Clinical Trials on anthropometric measurement
-
National Council of Scientific and Technical Research...Active, not recruitingCerebral Palsy | Nutrition Disorders | ChildArgentina
-
Yuksek Ihtisas UniversityCompleted
-
Leonardo Paroche de MatosJadhy Aquino Antunes; Bianca Prado de Lima Ramos; Daniele Fernanda Mantovani; Milla... and other collaboratorsNot yet recruitingGeriatrics | Health Services for the AgedBrazil
-
Hasanuddin UniversityRecruitingVitamin D DeficiencyIndonesia
-
Hacettepe UniversityEnrolling by invitation
-
Centre Henri BecquerelCompletedDiffuse Large B Cell Lymphoma | Grade IIIB Follicular LymphomaFrance
-
Lotung Poh-Ai HospitalCompletedObesity | Gastroesophageal Reflux DiseaseTaiwan
-
Kirsehir Ahi Evran UniversitesiNot yet recruiting
-
Sohag UniversityNot yet recruitingMalnutrition, Child
-
Assiut UniversityUnknown