BackgroundThe PROFRUVE study is a controlled intervention based on the Theory of Planned Behavior (TPB), which follows those behavioral theories that have proved to be the most effective at changing infant fruit and vegetable (FV) intake pattern. The main purpose of the study is to evaluate the effectiveness of an intervention program in increasing FV consumption in schoolchildren aged 8 to 10 and based on TPB.MethodsEligible classrooms within schools from Vitoria-Gasteiz (Basque Country, Spain) will be randomly assigned to the intervention (classrooms n = 4; children n = 86) or control (classrooms n = 4; children n = 86) group. The intervention group will receive 14 sessions of 60 min during an academic year (October to June). These sessions, designed by a multidisciplinary team, are based on TPB and are directed at modifying determinants of behavior (attitudes, subjective norms, perceived behavioral control and intention of consumption), and intake of FV itself. Both the process and the evolution of consumption and determinants of behavior will be evaluated (before, during, shortly after and a year after) using validated surveys, 7 day food records, 24 h reminders and questionnaires.DiscussionThis study will provide a valid and useful tool to achieve changes in the consumption of FV at school level. A negative result will be helpful in redefining new strategies in the framework of changing habits in the consumption of FV.Trial RegistrationThis study has been retrospectively registered at ClinicalTrials.gov. Identifier: NCT03400891. Data registered: 17/01/2018.
Purpose: The main objective of the PROFRUVE study is to evaluate the effectiveness of a TPB-based intervention program at increasing fruit and vegetable (FV) consumption in schoolchildren aged 7 to 10. Methods: Eight eligible classrooms were randomly assigned to the intervention (classrooms n=4; children n=90) or control group (classrooms n=4; children n=95). The intervention group received 14 sessions of one hour during an academic year (from October to June) but the control group did not. Sessions were based on the Theory of Planned Behavior (TPB) and focused on modifying FV intake. FV consumption was evaluated before, shortly after and one year after intervention ended using validated 7day food records. Powered by Editorial Manager® and ProduXion Manager® from Aries Systems CorporationResults: FV intake increased significantly in the intervention group (+0.45 servings/day; 95% CI 0.17 to 0.74; p=0.001) but not in the control group (+0.01 servings/day; 95% CI -0.20 to 0.22; p=0.409) shortly after the intervention. Long-term measurement showed that one year after intervention finished, the intervention group maintained the effect (+0.52 servings/day from baseline; 95% CI 0.22 to 0.78; p=0.003). Multiple lineal regression showed that receiving the intervention (B=0.345, p=0.045) was associated with higher FV intake change after adjusting the model by FV baseline intake, gender and family social economic status (SES) (R2=0.196). Conclusions: The intervention program based on TPB seems to be moderately effective in increasing FV intake and successful in maintaining the effect of the reached increase. Moreover, baseline FV intake determines the effect size of the intervention.
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