OverweightPRALIMAP-INESNCT01688453
Overweight Management and Social Inequalities
A study testing The strengthened care management in people with Overweight, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Background: The prevalence of overweight and obesity continues to increase in socially less advantaged populations but is stabilizing even is decreasing in socially more advantaged populations. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- The strengthened care management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,689 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Nov 2015
- Phase
- Interventional
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Attending grade 9 or 10 in one of the 35 state-run school of the Vosges department and be in a general, technological or vocational course,
- Aged ≤ 18 years old,
- not giving written refusal to participate in the trial,
- able to complete a questionnaire,
- overweight or obese according to the IOTF criteria (for BMI) and the McCarthy criteria (for waist circumference) and/or have a high eating disorder score, and/or express the need for management of excess weight,
- confirmed as corresponding to the 4 previous inclusion criteria by the physician, with elimination of adolescents with false-positive BMI (particularly athletic adolescents),
- agree to an overweight and obesity care management program.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Inequalities in Overweight and Obesity Management Care Access Among High School Adolescents
Background: The prevalence of overweight and obesity continues to increase in socially less advantaged populations but is stabilizing even is decreasing in socially more advantaged populations. The PRALIMAP trial highlighted the effectiveness of structured screening and care management in decreasing the prevalence of overweight and obesity in high school adolescents over 2 years. The PRALIMAP-INES trial aims to investigate whether a strengthened care management (CM) for socially less advantaged adolescents in school in the short and long term has an equivalent effect as a standard-CM on decreasing the prevalence of overweight and obesity among socially advantaged adolescents.
Intervention: PRALIMAP-INÉS is a mixed prospective and multicenter trial of 1,250 overweight and obese adolescents aged 13 to 18 years who are attending grade 9 and 10 in the 35 state-run schools of the Vosges department (northeastern France) for the academic years 2012-2013 2013-2014 and 2014-2015. Overweight adolescents (including obese) classified as advantaged are allocated to the standard-CM and those less advantaged are randomized to standard CM or strengthened-CM. The standard-CM consists of 5 collective sessions of 2 hr each performed in high school and supervised by a healthcare mobile team specialised in overweight and obesity care management for adolescents. The strengthened-CM consists of 5 collective sessions with the same standard operating procedure as the standard-CM with supplementary interventions between each session: strengthened solicitation with the adolescent and the family, peer-led educational sessions, motivational interviews, financial support for physical activity practice, cooking classes and multidisciplinary consultation meetings. Data on sociodemographics, anthropometrics, physical activity and mental health are collected at 3 visits: at the entry to grade 9 or 10 (before the intervention=T0), at the end of grade 9 or 10 (at the end of the intervention=T1) and at the end of grade 11 (1 year after the intervention=T2). Process evaluation data are also collected during the trial.
Expected results: To confirm the effectiveness of overweight CM for adolescents in a school setting and to highlight or not the effectiveness of specific strengthened interventions adapted for socially less advantaged adolescents to maintain social equality in access to overweight care.
Read the detailed description
Background: The prevalence of overweight and obesity continues to increase in socially less advantaged populations but is stabilizing even is decreasing in socially more advantaged populations. The PRALIMAP trial confirmed major social inequalities in overweight and obesity frequency in adolescents in grade 10. The trial highlighted the effectiveness of structured screening and care management in decreasing the prevalence of overweight and obesity in high school adolescents over 2 years. The PRALIMAP-INES trial aims to investigate whether a strengthened care management strategy for socially less advantaged adolescents in school in the short and long term (just after the intervention and 1 year later) has an equivalent effect as a standard-care management strategy on decreasing the prevalence of overweight and obesity among socially advantaged adolescents.
Hypothesis: A strengthened overweight and obesity care management strategy for overweight and obesity (risk factors of cancer) can improve care access for socially less advantaged adolescents and maintain social equality in terms of overweight and obesity prevalence.
Intervention: PRALIMAP-INÉS is a mixed prospective and multicenter trial (one randomised part and one non-randomised part) of 1,250 overweight and obese adolescents aged 13 to 18 years who are attending grade 9 and 10 in the 35 state-run schools of the Vosges department (northeastern France) for the academic years 2012-2013, 2013-2014 and 2014-2015. After a session to detect overweight and obese adolescents, the social status of included adolescents as "advantaged" or "less advantaged" is determined. Adolescents classified as advantaged are allocated to the standard-care management and those less advantaged are randomized to standard-care management or strengthened-care management. The standard-care management consists of 5 collective sessions of 2 hr each performed in high school and supervised by a healthcare mobile team specialised in overweight and obesity care management for adolescents. The team consists of physicians, dietitians, psychologists and sports educators from the AVRS Association. The content of sessions was validated in the PRALIMAP trial. The strengthened-care management consists of 5 collective sessions with the same standard operating procedure as the standard-care management with supplementary interventions between each session: strengthened solicitation with the adolescent and the family, peer-led educational sessions, motivational interviews, financial support for physical activity practice, cooking classes and multidisciplinary consultation meetings (adjusting the care management according to the social status). Data on sociodemographics, anthropometrics, physical activity and mental health are collected at 3 visits: at the entry to grade 9 or 10 (before the intervention = T0), at the end of grade 9 or 10 (at the end of the intervention = T1) and at the end of grade 10 or 11 (1 year after the intervention = T2). T1 measurement allows for evaluating the short-term effect of the intervention and T2, the long-term effect of a 1-year break from the intervention. Data on participation and from questionnaires, as well as focus group and activity reports, necessary for evaluation, are collected during the trial.
Expected results: With this trial, the investigators expect to confirm the effectiveness of overweight and obesity care management for adolescents in a school setting and to highlight or not the effectiveness of specific strengthened interventions adapted for socially less advantaged adolescents to maintain social equality in access to overweight and obesity care.
- Conditions
- Overweight
- Being tested
- Standard care management, The strengthened care management
- Keywords
- overweight/obesity, adolescence, care management
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard care managementBehavioural
The standard-care management program consists of 5 collective sessions of 2 hr each about nutritional practices (food and physical activity) and on changes of nutritional behaviours. The sessions are organized in high schools by the healthcare team in collaboration with pediatricians, dietitians and the Sickness Insurance Primary Fund.
The strengthened care managementBehavioural
The strengthened care management is the addition of the standard care management and of additional interventions.
The standard-care management program consists of 5 collective sessions of 2 hr each about nutritional practices (food and physical activity) and on changes of nutritional behaviours. The sessions are organized in high schools by the healthcare team in collaboration with pediatricians, dietitians and the Sickness Insurance Primary Fund.
The additional interventions are strengthened solicitation and accompaniment, peer-led education, motivational interview, financial support for physical activity practice, cooking classes and meetings of multidisciplinary consultation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: | Active comparator | Socially advantaged overweight or obese adolescents are allocated to the standard care management. Receives: Behavioral: Standard care management |
| Group 2 | Experimental | Socially less advantaged overweight or obese adolescents are allocated to the standard care management. Receives: Behavioral: Standard care management |
| Group 3 | Experimental | Socially less advantaged overweight or obese adolescents are allocated to the strengthened care management. Receives: Behavioral: The strengthened care management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index from to baseline to 1 and 2 years
BMI is measured at baseline(on grade 10 entry) and after 1 and 2 follow up years(at the end of grades 10 and 11).
Measured: 0-1-2 years
Change in overweight and obesity status according to IOTF norms
overweight and obesity status is calculated from BMI at each measurement time according to the IOTF norms for age and sex
Measured: up to 2 years
Change in BMI Z score from baseline to one and two years
BMI Z score is calculated from BMI at each time measurement using WHO reference and SAS macro
Measured: up to 2 years
Secondary outcomes (3)
Change in waist circumference
waist circumference is measured two times at each measurement point by trained nurses and validated by a practitioner
Measured: 2 years
change in eating attitude score from baseline to 1 and 2 years
Eating attitudes are measured at each measurement point using then EAT40 questionnaire
Measured: up to 2 years
Change in anxiety and depression scores from baseline to 1 and 2 years
HAD questionnaire is used to measure score at each follow-up point
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,689 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Serge Briançon, Pr, Principal investigator, University of Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688453
- Sponsor's protocol ID
- C11-46
- Acronym
- PRALIMAP-INES
- Status last verified
- Aug 2021
- First submitted
- 7 Sep 2012
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Saez L, Langlois J, Legrand K, Quinet MH, Lecomte E, Omorou AY, Briancon S; PRALIMAP-INES Trial Group. Reach and Acceptability of a Mobile Reminder Strategy and Facebook Group Intervention for Weight Management in Less Advantaged Adolescents: Insights From the PRALIMAP-INES Trial. JMIR Mhealth Uhealth. 2018 May 18;6(5):e110. doi: 10.2196/mhealth.7657.
PubMed 29776897Saez L, Legrand K, Alleyrat C, Ramisasoa S, Langlois J, Muller L, Omorou AY, De Lavenne R, Kivits J, Lecomte E, Briancon S; PRALIMAP-INES Trial Group. Using facilitator-receiver peer dyads matched according to socioeconomic status to promote behaviour change in overweight adolescents: a feasibility study. BMJ Open. 2018 Jun 22;8(6):e019731. doi: 10.1136/bmjopen-2017-019731.
PubMed 29934380Legrand K, Lecomte E, Langlois J, Muller L, Saez L, Quinet MH, Bohme P, Spitz E, Omorou AY, Briancon S; PRALIMAP-INES trial group. Reducing social inequalities in access to overweight and obesity care management for adolescents: The PRALIMAP-INES trial protocol and inclusion data analysis. Contemp Clin Trials Commun. 2017 Jun 16;7:141-157. doi: 10.1016/j.conctc.2017.05.010. eCollection 2017 Sep.
PubMed 29696179Manneville F, Omorou AY, Legrand K, Lecomte E, Rydberg JA, Briancon S, Guillemin F; PRALIMAP Trial Group. Sociodemographic and psychological characteristics associated with discrepancy between body satisfaction and weight change among adolescents. Prev Med. 2021 Sep;150:106668. doi: 10.1016/j.ypmed.2021.106668. Epub 2021 Jun 1.
PubMed 34087324Omorou AY, Manneville F, Langlois J, Legrand K, Bohme P, Muller L, Guillemin F, Briancon S, Lecomte E; PRALIMAP-INES Trial Group. Physical activity rather than sedentary behaviour is socially determined in French adolescents with overweight and obesity. Prev Med. 2020 May;134:106043. doi: 10.1016/j.ypmed.2020.106043. Epub 2020 Feb 22.
PubMed 32097754Dakin M, Manneville F, Langlois J, Briancon S, Lecomte E, Spitz E, Legrand K, Bohme P, Guillemin F, Omorou A. Role of dietary intake and physical activity in reducing weight social inequalities among adolescents: an application of G-formula to PRALIMAP-INES trial. Br J Nutr. 2024 Jul 28;132(2):182-191. doi: 10.1017/S0007114524001090. Epub 2024 May 27.
PubMed 38800976Julia C, Omorou A, Lecomte E, Langlois J, Touvier M, Hercberg S, Briancon S, Kesse-Guyot E, Guillemin F; PRALIMAP-INES Trial Group. Behavioural risk patterns in adolescents with excess weight participating in the PRALIMAP-INES trial. Public Health Nutr. 2023 Jan;26(1):96-105. doi: 10.1017/S136898002200057X. Epub 2022 Mar 11.
PubMed 35272723
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Inequalities in Overweight and Obesity Management Care Access Among High School Adolescents
- ClinicalTrials.gov ID
- NCT01688453
- Acronym / sponsor ID
- PRALIMAP-INES / C11-46
- Conditions
- Overweight
- Keywords
- overweight/obesity, adolescence, care management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,689 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Apr 2012 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 19 Sep 2012 (estimated)
- 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.
Background: The prevalence of overweight and obesity continues to increase in socially less advantaged populations but is stabilizing even is decreasing in socially more advantaged populations. The PRALIMAP trial highlighted the effectiveness of structured screening and care management in decreasing the prevalence of overweight and obesity in high school adolescents over 2 years. The PRALIMAP-INES trial aims to investigate whether a strengthened care management (CM) for socially less advantaged adolescents in school in the short and long term has an equivalent effect as a standard-CM on decreasing the prevalence of overweight and obesity among socially advantaged adolescents.
Intervention: PRALIMAP-INÉS is a mixed prospective and multicenter trial of 1,250 overweight and obese adolescents aged 13 to 18 years who are attending grade 9 and 10 in the 35 state-run schools of the Vosges department (northeastern France) for the academic years 2012-2013 2013-2014 and 2014-2015. Overweight adolescents (including obese) classified as advantaged are allocated to the standard-CM and those less advantaged are randomized to standard CM or strengthened-CM. The standard-CM consists of 5 collective sessions of 2 hr each performed in high school and supervised by a healthcare mobile team specialised in overweight and obesity care management for adolescents. The strengthened-CM consists of 5 collective sessions with the same standard operating procedure as the standard-CM with supplementary interventions between each session: strengthened solicitation with the adolescent and the family, peer-led educational sessions, motivational interviews, financial support for physical activity practice, cooking classes and multidisciplinary consultation meetings. Data on sociodemographics, anthropometrics, physical activity and mental health are collected at 3 visits: at the entry to grade 9 or 10 (before the intervention=T0), at the end of grade 9 or 10 (at the end of the intervention=T1) and at the end of grade 11 (1 year after the intervention=T2). Process evaluation data are also collected during the trial.
Expected results: To confirm the effectiveness of overweight CM for adolescents in a school setting and to highlight or not the effectiveness of specific strengthened interventions adapted for socially less advantaged adolescents to maintain social equality in access to overweight care.
Detailed description
Background: The prevalence of overweight and obesity continues to increase in socially less advantaged populations but is stabilizing even is decreasing in socially more advantaged populations. The PRALIMAP trial confirmed major social inequalities in overweight and obesity frequency in adolescents in grade 10. The trial highlighted the effectiveness of structured screening and care management in decreasing the prevalence of overweight and obesity in high school adolescents over 2 years. The PRALIMAP-INES trial aims to investigate whether a strengthened care management strategy for socially less advantaged adolescents in school in the short and long term (just after the intervention and 1 year later) has an equivalent effect as a standard-care management strategy on decreasing the prevalence of overweight and obesity among socially advantaged adolescents.
Hypothesis: A strengthened overweight and obesity care management strategy for overweight and obesity (risk factors of cancer) can improve care access for socially less advantaged adolescents and maintain social equality in terms of overweight and obesity prevalence.
Intervention: PRALIMAP-INÉS is a mixed prospective and multicenter trial (one randomised part and one non-randomised part) of 1,250 overweight and obese adolescents aged 13 to 18 years who are attending grade 9 and 10 in the 35 state-run schools of the Vosges department (northeastern France) for the academic years 2012-2013, 2013-2014 and 2014-2015. After a session to detect overweight and obese adolescents, the social status of included adolescents as "advantaged" or "less advantaged" is determined. Adolescents classified as advantaged are allocated to the standard-care management and those less advantaged are randomized to standard-care management or strengthened-care management. The standard-care management consists of 5 collective sessions of 2 hr each performed in high school and supervised by a healthcare mobile team specialised in overweight and obesity care management for adolescents. The team consists of physicians, dietitians, psychologists and sports educators from the AVRS Association. The content of sessions was validated in the PRALIMAP trial. The strengthened-care management consists of 5 collective sessions with the same standard operating procedure as the standard-care management with supplementary interventions between each session: strengthened solicitation with the adolescent and the family, peer-led educational sessions, motivational interviews, financial support for physical activity practice, cooking classes and multidisciplinary consultation meetings (adjusting the care management according to the social status). Data on sociodemographics, anthropometrics, physical activity and mental health are collected at 3 visits: at the entry to grade 9 or 10 (before the intervention = T0), at the end of grade 9 or 10 (at the end of the intervention = T1) and at the end of grade 10 or 11 (1 year after the intervention = T2). T1 measurement allows for evaluating the short-term effect of the intervention and T2, the long-term effect of a 1-year break from the intervention. Data on participation and from questionnaires, as well as focus group and activity reports, necessary for evaluation, are collected during the trial.
Expected results: With this trial, the investigators expect to confirm the effectiveness of overweight and obesity care management for adolescents in a school setting and to highlight or not the effectiveness of specific strengthened interventions adapted for socially less advantaged adolescents to maintain social equality in access to overweight and obesity care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: | Active comparator | Behavioral: Standard care managementSocially advantaged overweight or obese adolescents are allocated to the standard care management. |
| Group 2 | Experimental | Behavioral: Standard care managementSocially less advantaged overweight or obese adolescents are allocated to the standard care management. |
| Group 3 | Experimental | Behavioral: The strengthened care managementSocially less advantaged overweight or obese adolescents are allocated to the strengthened care management. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Attending grade 9 or 10 in one of the 35 state-run school of the Vosges department and be in a general, technological or vocational course,
- Aged ≤ 18 years old,
- not giving written refusal to participate in the trial,
- able to complete a questionnaire,
- overweight or obese according to the IOTF criteria (for BMI) and the McCarthy criteria (for waist circumference) and/or have a high eating disorder score, and/or express the need for management of excess weight,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard care managementThe standard-care management program consists of 5 collective sessions of 2 hr each about nutritional practices (food and physical activity) and on changes of nutritional behaviours. The sessions are organized in high schools by the healthcare team in collaboration with pediatricians, dietitians and the Sickness Insurance Primary Fund. | Behavioural | Group 1:, Group 2 |
| The strengthened care managementThe strengthened care management is the addition of the standard care management and of additional interventions. The standard-care management program consists of 5 collective sessions of 2 hr each about nutritional practices (food and physical activity) and on changes of nutritional behaviours. The sessions are organized in high schools by the healthcare team in collaboration with pediatricians, dietitians and the Sickness Insurance Primary Fund. The additional interventions are strengthened solicitation and accompaniment, peer-led education, motivational interview, financial support for physical activity practice, cooking classes and meetings of multidisciplinary consultation. | Behavioural | Group 3 |
Primary outcome
Change in Body Mass Index from to baseline to 1 and 2 years
Time frame: 0-1-2 years
BMI is measured at baseline(on grade 10 entry) and after 1 and 2 follow up years(at the end of grades 10 and 11).
Change in overweight and obesity status according to IOTF norms
Time frame: up to 2 years
overweight and obesity status is calculated from BMI at each measurement time according to the IOTF norms for age and sex
Change in BMI Z score from baseline to one and two years
Time frame: up to 2 years
BMI Z score is calculated from BMI at each time measurement using WHO reference and SAS macro
3 secondary outcomes
Change in waist circumference
Time frame: 2 years
change in eating attitude score from baseline to 1 and 2 years
Time frame: up to 2 years
Change in anxiety and depression scores from baseline to 1 and 2 years
Time frame: up to 2 years
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 10 Dec 2025.
- Results publication: PubMed 29776897Saez L, Langlois J, Legrand K, Quinet MH, Lecomte E, Omorou AY, Briancon S; PRALIMAP-INES Trial Group. Reach and Acceptability of a Mobile Reminder Strategy and Facebook Group Intervention for Weight Management in Less Advantaged Adolescents: Insights From the PRALIMAP-INES Trial. JMIR Mhealth Uhealth. 2018 May 18;6(5):e110. doi: 10.2196/mhealth.7657.
- Results publication: PubMed 29934380Saez L, Legrand K, Alleyrat C, Ramisasoa S, Langlois J, Muller L, Omorou AY, De Lavenne R, Kivits J, Lecomte E, Briancon S; PRALIMAP-INES Trial Group. Using facilitator-receiver peer dyads matched according to socioeconomic status to promote behaviour change in overweight adolescents: a feasibility study. BMJ Open. 2018 Jun 22;8(6):e019731. doi: 10.1136/bmjopen-2017-019731.
- Results publication: PubMed 29696179Legrand K, Lecomte E, Langlois J, Muller L, Saez L, Quinet MH, Bohme P, Spitz E, Omorou AY, Briancon S; PRALIMAP-INES trial group. Reducing social inequalities in access to overweight and obesity care management for adolescents: The PRALIMAP-INES trial protocol and inclusion data analysis. Contemp Clin Trials Commun. 2017 Jun 16;7:141-157. doi: 10.1016/j.conctc.2017.05.010. eCollection 2017 Sep.
- Results publication: PubMed 34087324Manneville F, Omorou AY, Legrand K, Lecomte E, Rydberg JA, Briancon S, Guillemin F; PRALIMAP Trial Group. Sociodemographic and psychological characteristics associated with discrepancy between body satisfaction and weight change among adolescents. Prev Med. 2021 Sep;150:106668. doi: 10.1016/j.ypmed.2021.106668. Epub 2021 Jun 1.
- Results publication: PubMed 32097754Omorou AY, Manneville F, Langlois J, Legrand K, Bohme P, Muller L, Guillemin F, Briancon S, Lecomte E; PRALIMAP-INES Trial Group. Physical activity rather than sedentary behaviour is socially determined in French adolescents with overweight and obesity. Prev Med. 2020 May;134:106043. doi: 10.1016/j.ypmed.2020.106043. Epub 2020 Feb 22.
- Derived from this study: PubMed 38800976Dakin M, Manneville F, Langlois J, Briancon S, Lecomte E, Spitz E, Legrand K, Bohme P, Guillemin F, Omorou A. Role of dietary intake and physical activity in reducing weight social inequalities among adolescents: an application of G-formula to PRALIMAP-INES trial. Br J Nutr. 2024 Jul 28;132(2):182-191. doi: 10.1017/S0007114524001090. Epub 2024 May 27.
- Derived from this study: PubMed 35272723Julia C, Omorou A, Lecomte E, Langlois J, Touvier M, Hercberg S, Briancon S, Kesse-Guyot E, Guillemin F; PRALIMAP-INES Trial Group. Behavioural risk patterns in adolescents with excess weight participating in the PRALIMAP-INES trial. Public Health Nutr. 2023 Jan;26(1):96-105. doi: 10.1017/S136898002200057X. Epub 2022 Mar 11.
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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.
Serge Briançon, Pr principal investigator
University of Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The strengthened care management in people with Overweight, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 7 inclusion and 0 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 10 Dec 2025. 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 France. 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?
Change in Body Mass Index from to baseline to 1 and 2 years (time frame: 0-1-2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01688453, which also lists 7 linked publications.
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 10 Dec 2025.