Weight Changes Among Martinican Prisoners

Weight Loss Clinical Trial

— NUTRI-LAJÔL  

Official title:

Weight Changes Among Martinican Prisoners

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05982132
• Other study ID #: 19_RIPH3_13
• Status: Recruiting
• Start date: January 11, 2023
• Est. completion date: April 2024

Study information

• Verified date: October 2023
• Source: University Hospital Center of Martinique
• Contact: Veronique PELONDE-ERIMEE, RCA
• Phone: 0596592697
• Email: veronique.pelonde-erimee[@]chu-martinique.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 227
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Weight Gain
• Weight Loss

Intervention

Other:
• anthropometric measurement
Measurement of weight and other anthropometrics data

Locations

Country	Name	City	State
Martinique	CHU Martinique	Ducos

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Center of Martinique

Country where clinical trial is conducted

Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Body mass index measurement change between baseline and Month 3 visit	BMI in kg/m^2	This outcome will be collected at baseline (entrance medical examination) and Month 3 visit
Secondary	Waist size measurement change between baseline and Month 3 visit	Waist size in centimeters	This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
Secondary	Lean mass measurement change between baseline and Month 3 visit	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
Secondary	Body fat measurement change between baseline and Month 3 visit	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
Secondary	Percentage body water measurement change between baseline and Month 3 visit	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
Secondary	Visceral fat measurement change between baseline and Month 3 visit	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
Secondary	Basal metabolic rate measurement change between baseline and Month 3 visit	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
Secondary	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	This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
Secondary	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	This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
Secondary	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	This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
Secondary	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.	This outcome will be collected at baseline (entrance medical examination) and visit at 3 months