- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06543875
Overweight, Obesity and Weight Variation Among Incarcerated Women in French Guiana: a Study of Factors Associated With Weight Gain (PPFCPG)
Overweight and obesity are a public health issue, given the morbi-mortality they entail: increase in chronic diseases such as cardiovascular disease, diabetes, musculoskeletal disorders, certain cancers.
According to the 2019 European Health Survey, French Guiana has a high rate of overweight and obesity, affecting 51% of its population (compared with 47% in mainland France), with a higher prevalence among women (23%), this phenomenon being partly attributed to unfavorable eating habits and a sedentary lifestyle. Another study in French Guiana showed that 54.7% of those surveyed were overweight or obese, with a higher risk of obesity among single women, often from non-French Caribbean and South American immigrant backgrounds, unemployed or poorly educated. Some of these risk factors are found in the general prison population: immigrant population, unemployed, low socio-educational level.
A meta-analysis published in 2017 analyzed weight variations in individuals during their period of incarceration. All but one study reported an increase in BMI and weight gain, in a significant proportion of participants. Weight gain was associated with gender, and was higher in women. A systematic review of 2020 on cardiovascular risks associated with incarceration revealed, through meta-regression, a mean weight increase of 5.3 kg (CI95%: 0.5 to 10.1) and a variation in Body Mass Index (BMI) of 1.8 kg/m2 (CI95%: -0.9 to 4.6) after two years of incarceration, attributed to a sedentary lifestyle, inappropriate diet, forced smoking cessation, use of psychotropic medication and high levels of stress.
The higher prevalence of obesity among women is a trend observed both in French Guiana and in the prison environment, where weight gain is associated with the female gender. There are currently no studies examining the weight of female prisoners in French Guiana, its evolution and the identification of risk factors linked to weight gain in the CPG.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Guyane Française
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Cayenne, Guyane Française, French Guiana, 97306
- Centre Hospitalier de Cayenne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Female adult in prison for more than 7 days at the time of the interviews
Exclusion Criteria:
- Refusal to participate
- Cognitive impairment or lack of communication resulting in inability to complete questionnaire
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Women incarcerated at the Penitentiary Center of French Guiana
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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overall weight of women incarcerated
Time Frame: from date of incarceration until the date of inclusion, at least 7 days and no upper limit
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This variation is calculated by subtracting the initial weight on entry into the current weight at the time of the interview. T Weight measurements are taken in kilograms (kg to one decimal place) at two decimal place) at two key points: o These measurements are valid and reproducible: weight taken on a standardized scale scale, in light clothing and barefoot, The primary endpoint will quantify changes in weight I during the period of incarceration, and will serve as a basis for to assess the impact of various factors on weight gain in female women prisoners. |
from date of incarceration until the date of inclusion, at least 7 days and no upper limit
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overall BMI trends of women incarcerated
Time Frame: from date of incarceration until the date of inclusion, at least 7 days and no upper limit
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This variation is calculated by subtracting the initial weight on entry into the current weight at the time of the interview for BMI. Weight measurements are taken in kilograms (kg to one decimal place) at two decimal place) at two key points: on entry into detention and at the time of the and during the interview, based on medical records and individual individual interviews. BMI will be calculated using weight and height: calculation of body mass index (BMI) body mass index (BMI): weight (kg) / height (m2). |
from date of incarceration until the date of inclusion, at least 7 days and no upper limit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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1) Study changes in weight over time
Time Frame: from date of incarceration until the date of inclusion, at least 7 days and no upper limit
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Intermediate weights (kg to one decimal place) available in the medical record between entry into detention and inclusion will be recorded This will enable a more precise study of changes in weight as a function of time and length of incarceration.
The frequency with which intermediate weights are recorded in a woman's medical record may vary from one patient, as they are not systematically recorded during medical consultations, when they take place.
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from date of incarceration until the date of inclusion, at least 7 days and no upper limit
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1) Study changes in BMI over time
Time Frame: from date of incarceration until the date of inclusion, at least 7 days and no upper limit
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Intermediate weights (kg to one decimal place) available in the medical record between entry into detention and inclusion will be recorded, and intermediate BMIs calculated.
This will enable a more precise study of changes in weight and BMI as a function of time and length of incarceration.
The frequency with which intermediate weights are recorded in a woman's medical record may vary from one patient, as they are not systematically recorded during medical consultations, when they take place.
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from date of incarceration until the date of inclusion, at least 7 days and no upper limit
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prevalence of overweight and obesity, including those at high risk of metabolic and vascular disease:
Time Frame: from date of incarceration until the date of inclusion, at least 7 days and no upper limit
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On the one hand, at entry into detention, and on the other, at inclusion. Calculation of body mass index (BMI): weight (kg) / height (m2). Interpretation of BMI according to WHO recommendations:
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from date of incarceration until the date of inclusion, at least 7 days and no upper limit
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3) Describe the population of female inmates incarcerated
Time Frame: from date of incarceration until the date of inclusion, at least 7 days and no upper limit
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collect socio-demographic and economic data, lifestyle habits, medical history, medication intake, using the medical record and questionnaire. Judicial information : Socio-demographic information : Clinical information : Habitus information : Medical information : |
from date of incarceration until the date of inclusion, at least 7 days and no upper limit
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factors associated with weight gain during incarceration: Comparison between women who have gained weight, to those who have not gained weight
Time Frame: from date of incarceration until the date of inclusion, at least 7 days and no upper limit
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Weight gain is evidenced by by an increase in BMI >/= 1 point (or definition of a delta in of a delta in kilograms). a Questionnaire will be carried out during the interview with the patient. Results concerning the following variable will be aggregated in order to identify which factor is implicated in weight change between physical activity, sleep quantity and quality, eating habits, habits linked to incarceration, number of female cellmates cell, presence of intra- and extra-custodial contacts access to visiting room and telephone, whether or not trial has been completed, work at CPG |
from date of incarceration until the date of inclusion, at least 7 days and no upper limit
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPFCPG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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