Weight Loss Clinical Trial
— NUTRI-LAJÔLOfficial title:
Weight Changes Among Martinican Prisoners
NCT number | NCT05982132 |
Other study ID # | 19_RIPH3_13 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 11, 2023 |
Est. completion date | April 2024 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Martinique | CHU Martinique | Ducos |
Lead Sponsor | Collaborator |
---|---|
University Hospital Center of Martinique |
Martinique,
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 |
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