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Background: Depression is one of the leading causes of illness and disability among young people. In the Netherlands, one in twelve Dutch adolescents has experienced depression in the last 12 months. Pre-vocational students are at higher risk for elevated depressive symptoms. Effective interventions, especially for this risk group, are therefore needed to prevent the onset of depression or mitigate the adverse long-term effects of depression. The aim of this study is to examine the effectiveness and implementation of a school-based program Happy Lessons (HL), that aims to prevent depression and promote well-being among pre-vocational students.Methods: A cluster randomized controlled trial (RCT) with students randomized to HL or to care as usual will be conducted. Pre-vocational students in their first or second year (aged 12 to 14) will participate in the study. Subjects in both conditions will complete assessments at baseline and at 3- and 6-months follow-up. The primary outcome will be depressive symptoms using the Center for Epidemiologic Studies Depression Scale (CES-D) at 6-months follow-up. Secondary outcomes are well-being using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) and life satisfaction (Cantril Ladder) measured at 6-months follow-up. Alongside the trial, an implementation study will be conducted to evaluate the implementation of HL, using both quantitative and qualitative methods (interviews, survey, and classroom observations).Discussion: The results from both the RCT and implementation study will contribute to the limited evidence base on effective school-based interventions for the prevention of depression and promotion of well-being among pre-vocational adolescents. In addition, insights from the implementation study will aid identifying factors relevant for optimizing the future implementation and scale-up of HL to other schools and contexts.Trial Registration: This study was registered on 20 September 2021 in the Dutch Trial Register ( NL9732 ). [ABSTRACT FROM AUTHOR]

Background: The preconception period provides a window of opportunity for interventions aiming to reduce unhealthy lifestyle behaviours and their negative effect on pregnancy outcomes. This study aimed to assess the effectiveness of a locally tailored preconception care (PCC) intervention in a hybrid-II effectiveness implementation design.Methods: A stepped-wedge cluster randomized controlled trial was performed in four Dutch municipalities. The intervention contained a social marketing strategy aiming to improve the uptake (prospective parents) and the provision (healthcare providers) of PCC. Prospective parents participated by administering a questionnaire in early pregnancy recalling their preconceptional behaviours. Experiences of healthcare providers were also evaluated through questionnaires. The composite primary outcome was adherence to at least three out of four preconceptional lifestyle recommendations (early initiation of folic acid supplements, healthy nutrition, no smoking or alcohol use). Secondary outcomes were preconceptional lifestyle behaviour change, (online) reach of the intervention and improved knowledge among healthcare providers.Results: A total of 850 women and 154 men participated in the control phase and 213 women and 39 men in the intervention phase. The composite primary outcome significantly improved among women participating in the municipality where the reach of the intervention was highest (Relative Risk (RR) 1.57 (95% Confidence Interval (CI) 1.11-2.22). Among women, vegetable intake had significantly improved in the intervention phase (RR 1.82 (95%CI 1.14-2.91)). The aimed online reach- and engagement rate of the intervention was achieved most of the time. Also, after the intervention, more healthcare providers were aware of PCC-risk factors (54.5% vs. 47.7%; p = 0.040) and more healthcare providers considered it easier to start a conversation about PCC (75.0% vs. 47.9%; p = 0.030).Conclusion: The intervention showed some tentative positive effects on lifestyle behaviours among prospective parents. Primarily on vegetable intake and the knowledge and competence of healthcare providers. The results of this study contribute to the evidence regarding successfully implementing PCC-interventions to optimize the health of prospective parents and future generations.Trial Registration: Dutch Trial Register: NL7784 (Registered 06/06/2019). [ABSTRACT FROM AUTHOR]