ObesityPPFCPGNCT06543875
Overweight, Obesity and Weight Variation Among Incarcerated Women in French Guiana: a Study of Factors Associated With Weight Gain
An observational study of Obesity and Overweight, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- How many people
- 85 participants
- Where
- 1 siteFrench Guiana
- Study dates
- 14 Dec 2023to 26 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Exhaustive selection method including all women incarcerated at the prison when the interviews were conducted.
Who may be able to join
- Female adult in prison for more than 7 days at the time of the interviews
Who cannot join
- Refusal to participate
- Cognitive impairment or lack of communication resulting in inability to complete questionnaire
Trial locations and contacts
1 site in 1 country.
French Guiana1 site
Centre Hospitalier de Cayenne
Cayenne, Guyane Française, 97306
About this study
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.
Read more
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.
- Conditions
- Obesity, Overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women incarcerated at the Penitentiary Center of French Guiana | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
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.
Measured: from date of incarceration until the date of inclusion, at least 7 days and no upper limit
1) Study changes in BMI over time
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.
Measured: 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:
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:
- < 18.5 kg/m²: underweight ;
- = or > 18.5 and < 25 kg/m²: normal build;
- = or > 25 and < 30 kg/m²: overweight;
- = or > 30 kg/m²: obese; Waist circumference will be measured in cm during the interview only, using a tape measure (midway between the lower edge of the last palpable rib and the top of the iliac crest, with a tape measure placed horizontally, at the end of a normal exhalation according to the Belgian Association for the Study of Obesity recommended by HAS). HAS classification: high waist circumference in women when >/= 80 cm.
Measured: 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
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 :
Measured: 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
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
Measured: from date of incarceration until the date of inclusion, at least 7 days and no upper limit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start14 Dec 2023
- Primary completion26 Feb 2024
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543875
- Sponsor's protocol ID
- PPFCPG
- Acronym
- PPFCPG
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overweight, Obesity and Weight Variation Among Incarcerated Women in French Guiana: a Study of Factors Associated With Weight Gain
- ClinicalTrials.gov ID
- NCT06543875
- Acronym / sponsor ID
- PPFCPG / PPFCPG
- Conditions
- Obesity, Overweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women incarcerated at the Penitentiary Center of French Guiana | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Exhaustive selection method including all women incarcerated at the prison when the interviews were conducted.
Key inclusion criteria (1 listed)
- Female adult in prison for more than 7 days at the time of the interviews
Key exclusion criteria (2 listed)
- Refusal to participate
- Cognitive impairment or lack of communication resulting in inability to complete questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall weight of women incarcerated
Time frame: from date of incarceration until the date of inclusion, at least 7 days and no upper limit
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.
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
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).
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Overweight, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in French Guiana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall weight of women incarcerated (time frame: from date of incarceration until the date of inclusion, at least 7 days and no upper limit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.