Contemporary Clinical Trials Communications (Sep 2017)
Reducing social inequalities in access to overweight and obesity care management for adolescents: The PRALIMAP-INÈS trial protocol and inclusion data analysis
Abstract
Background: Despite social inequalities in overweight/obesity prevalence, evidence-based public health interventions to reduce them are scarce. The PRALIMAP-INÈS trial aimed to investigate whether a strengthened-care management for adolescents with low socioeconomic status has an equivalent effect in preventing and reducing overweight as a standard-care management for high socioeconomic status adolescents. Methods: PRALIMAP-INÈS was a mixed, prospective and multicenter trial including 35 state-run schools. It admitted overweight or obese adolescents, age 13–18 years old, for 3 consecutive academic years. One-year interventions were implemented. Data were collected before (T0), after (T1) and post (T2) intervention. Among 2113 eligible adolescents who completed questionnaires, 1639 were proposed for inclusion and 1419 were included (220 parental refusals). Two groups were constituted according to the Family Affluence Scale (FAS) score: the less advantaged (FAS≤5) were randomly assigned to 2 groups in a 2/1 ratio. The 3 intervention groups were: advantaged with standard-care management (A.S, n = 808), less advantaged with standard-care management (LA.S, n = 196), and less advantaged with standard and strengthened-care management (LA.S.S, n = 415). The standard-care management was based on the patient education principle and consisted of 5 collective sessions. The strengthened-care management was based on the proportionate universalism principle and consisted of activities adapted to needs. Inclusion results: The written parental refusal was less frequent among less advantaged and more overweight adolescents. A dramatic linear social gradient in overweight was evidenced. Discussion: The PRALIMAP-INÈS outcomes should inform how effectively a socially adapted public health program can avoid worsening social inequalities in overweight adolescents attending school. Trial registration: ClinicalTrials.gov (NCT01688453). Keywords: Adolescents, Overweight and obesity, Social class, Standard care, Strengthened care