Overweight Management and Social Inequalities
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

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. 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.
    

Intervention name(s): Standard care management; The strengthened care management
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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 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.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: overweight/obesity; adolescence; care management