NCT06543875

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

July 31, 2024

Last Update Submit

August 5, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • overall weight of women incarcerated

    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

  • overall BMI trends of women incarcerated

    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

Secondary Outcomes (5)

  • 1) Study changes in weight over time

    from date of incarceration until the date of inclusion, at least 7 days and no upper limit

  • 1) Study changes in BMI over time

    from date of incarceration until the date of inclusion, at least 7 days and no upper limit

  • prevalence of overweight and obesity, including those at high risk of metabolic and vascular disease:

    from date of incarceration until the date of inclusion, at least 7 days and no upper limit

  • 3) Describe the population of female inmates incarcerated

    from date of incarceration until the date of inclusion, at least 7 days and no upper limit

  • factors associated with weight gain during incarceration: Comparison between women who have gained weight, to those who have not gained weight

    from date of incarceration until the date of inclusion, at least 7 days and no upper limit

Study Arms (1)

Women incarcerated at the Penitentiary Center of French Guiana

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Exhaustive selection method including all women incarcerated at the prison when the interviews were conducted.

You may qualify if:

  • Female adult in prison for more than 7 days at the time of the interviews

You may not qualify if:

  • Refusal to participate
  • Cognitive impairment or lack of communication resulting in inability to complete questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Cayenne

Cayenne, Guyane Française, 97306, French Guiana

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 9, 2024

Study Start

December 14, 2023

Primary Completion

February 26, 2024

Study Completion

February 26, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Locations