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The Dutch Obesity Intervention in Teenagers (DOiT) cluster controlled implementation trial: Intervention effects and mediators and moderators of adiposity and energy balance-related behaviours

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The Dutch Obesity Intervention in Teenagers (DOiT) programme is an evidence-based obesity prevention programme tailored to adolescents attending the first two years of prevocational education in the Netherlands. The initial programme showed promising results during an effectiveness trial. The programme was adapted and prepared for nationwide dissemination. To gain more insight into the process of translating evidence-based approaches into ‘real world’ (i.e., ‘natural’) conditions, our research aims were to evaluate the impact of the DOiT-implementation programme on adolescents’ adiposity and energy balance-related behaviours during natural dissemination and to explore the mediating and moderating factors underlying the DOiT intervention effects. We conducted a cluster-controlled implementation trial with 20 voluntary intervention schools (n=1002 adolescents) and 9 comparable control schools (n = 484 adolescents). We measured adolescents’ body height and weight, skinfold thicknesses, and waist circumference. We assessed adolescents’ dietary and physical activity behaviours by means of self-report. Data were collected at baseline and at 20-months follow-up. We used multivariable multilevel linear or logistic regression analyses to evaluate the intervention effects and to test the hypothesised behavioural mediating factors. We checked for potential effect modification by gender, ethnicity and education level. We found no significant intervention effects on any of the adiposity measures or behavioural outcomes. Furthermore, we found no mediating effects by any of the hypothesised behavioural mediators. Stratified analyses for gender showed that the intervention was effective in reducing sugar-containing beverage consumption in girls (B = -188.2 ml/day; 95% CI = -344.0; -32.3). In boys, we found a significant positive intervention effect on breakfast frequency (B = 0.29 days/week; 95% CI = 0.01; 0.58). Stratified analyses for education level showed an adverse intervention effect (B = 0.09; 95% CI = 0.02; 0.16) on BMI z-scores for adolescents attending the vocational education track. Although not successful in changing adolescents’ adiposity, the DOiT-implementation programme had some beneficial effects on specific obesity-related behaviours in subgroups. This study underlines the difficulty of translating intervention effectiveness in controlled settings to real world contexts. Adaptations to the implementation strategy are needed in order to promote implementation as intended by the teachers. Trial registration Current Controlled Trials ISRCTN92755979.
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... Study duration Four were of 3 to 4 years duration [10,12,13,18], nine studies 2 to <3 years of duration [11,14,17,19,22,24,26,31,37], seven studies duration of 1 to <2 years [20,21,23,25,30,34,36], eight studies were < 1-year duration [9, 16, 27-29, 32, 33, 35] and one study in 8 month mid-way assessment [15]. ...
... Ten were delivered by the school staff including physical education (PE) teachers [11-13, 17, 21, 26, 29-32], four were by the school teachers and research team members [9,24,28,36], two were by the PE teachers and research team members [16,37], seven were by the school teachers [15,18,20,23,25,33,35], two were by the trained research assistant [19,34], one study by school PE teachers and community guest instructor [14]; school project officer and student ambassadors 10 ; trained professionals and interviewers [22]; research staff [27]. ...
... Three studies were delivered by the school staff including PE teachers [11][12][13], three were by the research staff [27,32,37], two were by the dietician and psychologist [14,34], four were by the research team [9,16,19,24], and six were by the trained/ school teachers [15,18,20,23,25,36], intervention delivered by the dietician or final year U.G. dietetic students, school staff and PE teachers [21]; nursing expert [17]; accredited dietician [28]; school project officer and student ambassadors [10]; facilitator [29]; nutrition and dietetic students [33]; five studies were not measured and not delivered [22,26,30,31,35]. ...
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Purpose: It’s a known factor that obesity and overweight among adolescentsare major emerging global health problems associated with morbidityand mortality throughout their life in developed and developing countries. There is evidence that reducing overweight and obesity by increasing awareness, self-efficacy, and contemplation to adopt a health-promoting lifestyle.The aim of this review how the theory and model used to reduce this burden through vicarious interventional activities among adolescence (10-19 years)in a school setting. Methods: A literature search was performed in four databases to identify published studies between January 2009 and December 2019. Randomized control trial exploring the multiple interventional effects on obesity and overweight by utilization of with or without theoretical constructs and outcome on body mass index. Results: Originally references searched were 2112 abstracts and full-text articles. The total population was 34,846 adolescents. Most of the multiple interventionshad little positive effect onphysical activity, dietary intake, and sedentary behavior changes directly on BMI. Only three studies show changes in behavior through theory. Minimal studies reported the involvement and motivation of parents, friends, and teachers for themselves and adolescents. Conclusion: The contemporary review to visualizemultiple interventions, and how models and theory focused on various pragmatic activities in the delivery and outcome in school settings among adolescents.
... Seven studies recruited adolescents of the general populations (n = 3978), and nine studies recruited adolescents with low socio-economic status (SES) (n = 4826). Twelve studies were conducted at school [70][71][72][73][74][75][76][77][78][79][80][81]. All studies were educational/behavioral interventions. ...
... The quality of the studies ranged from 'good' to 'fair,' with nine studies ranging 'good' and seven ranging 'fair.' Eight studies did not perform or did not report proper randomization method [72,74,76,[78][79][80]83,85]. Only five studies concealed the treatment allocation, one blinded the participants and providers, and three blinded the outcome assessors to group assignments, mainly due to the nature of the study design and the education module [73,75,77,82,84]. ...
... The majority of the studies had similar baseline characteristics. All studies used validated and reliable measures to assess the outcomes [70][71][72][73][74][75][76][77][78][79][80][81][82][83][84][85]. Most of the studies had an overall dropout rate of less than 20% at the endpoint [70][71][72][73][74][75]77,78,[80][81][82][83]85]. ...
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Objective: To determine the impact of educational intervention in reducing the consumption of sugar-sweetened beverages (SSBs) and 100% fruit juice in children and adolescents. Design: We conducted a comprehensive Ovid Medline and Scopus search. Articles had to be peer-reviewed, full-text and published in English. Studies had to be controlled intervention, published between 1 January 2010 to 7 February 2021, and in children and adolescents. Study quality was measured using the Quality Assessment Tool for Controlled Intervention Studies. Results: Forty intervention articles were included in this review involving 25,069 children and adolescents. All studies employed a quantitative research method using the Randomized Controlled Trial designs. Twenty-eight out of forty interventions used psychosocial theories. Study quality ranged from 'fair' to 'good.' Results showed that education intervention effectively reduced SSBs, and reduced 100% fruit juice in children. Expert opinion: Reducing the SSBs consumption in children should be initiated by conducting school-based programs consisting of interactive learning process, psychosocial theories and the involvement of parents or caregivers. Theories that focus on personal, behavior and environment factors improve the effectiveness of the intervention. More research is warranted to investigate the impacts of 100% fruit juice on obesity, dental caries and risk of co-morbidities in children.
... The characteristics of the included studies are outlined in Table 3. [34][35][36][37][38][39][40][41][42][43] Of the 10 included scaled-up studies, 3 each were conducted in Australia 34-36 and the United States, 37-39 and 1 each was conducted in Canada, 40 the Netherlands, 41 Sweden, 42 and the United Kingdom. 43 One of the scaled-up interventions included preschool children (aged 3-5 years), 35 3 included primary-school children (aged 6-12 years), 37,40,42 and another focused on parent-child dyads. ...
... The characteristics of the included studies are outlined in Table 3. [34][35][36][37][38][39][40][41][42][43] Of the 10 included scaled-up studies, 3 each were conducted in Australia 34-36 and the United States, 37-39 and 1 each was conducted in Canada, 40 the Netherlands, 41 Sweden, 42 and the United Kingdom. 43 One of the scaled-up interventions included preschool children (aged 3-5 years), 35 3 included primary-school children (aged 6-12 years), 37,40,42 and another focused on parent-child dyads. ...
... PRISMA flow diagram of included studies DOiT 41 significantly improved in adolescent boys but not girls. Differences in effects established before and after scale-up (scale-up penalty)Four of the 10 included pairs of interventions did not provide sufficient information to enable an assessment of the scale-up effect on dietary outcomes.36,39,41,42 One did not have the same measure of F&V,39 another did not have a common measure for SSBs,36 and the other 2 (although they had a common measure of SSB 41 or F&V 42 intake at prescale and scale-up) did not have a significant effect on those measures at prescale. ...
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Context: Public health nutrition interventions shown to be effective under optimal research conditions need to be scaled up and implemented in real-world settings. Objectives: The primary aim for this review was to assess the effectiveness of scaled-up public health nutrition interventions with proven efficacy, as examined in a randomized controlled trial. Secondary objectives were to: 1) determine if the effect size of scaled-up interventions were comparable to the prescale effect, and; 2) identify any adaptations made during the scale-up process. Data sources: Six electronic databases were searched and field experts contacted. Study selection: An intervention was considered scaled up if it was delivered on a larger scale than a preceding randomized controlled trial ("prescale") in which a significant intervention effect (P ≤ 0.05) was reported on a measure of nutrition. Data extraction: Two reviewers independently performed screening and data extraction. Effect size differences between prescale and scaled-up interventions were quantified. Adaptations to scale-up studies were coded according to the Adaptome model. Results: Ten scaled-up nutrition interventions were identified. The effect size difference between prescale trials and scaled-up studies ranged from -32.2% to 222% (median, 50%). All studies made adaptations between prescale to scaled-up interventions. Conclusion: The effects of nutrition interventions implemented at scale typically were half that achieved in prior efficacy trials. Identifying effective scale-up strategies and methods to support retainment of the original prescale effect size is urgently needed to inform public health policy. Systematic review registration: PROSPERO registration no.CRD42020149267.
... However, as this was a noninferiority trial, and both arms received an active PACE intervention, any data collection limitations are associated with both trial arms and should not obscure the noninferiority analyses. Teacher logbooks have also been use for all evaluations of PACE to-date (originally chosen based on use in other school-based studies [40,51,68] and pragmatics [16,18]), and a consistent outcome measure may, in future, enable the assessment of any 'scaleup penalty' [20]. In addition, the generalisability of the findings are limited as the trial was undertaken within one health service region. ...
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Background To maximise their potential health benefits, school-based physical activity policies need to be implemented at scale. This paper describes the third in a sequence of trials that sought to optimise an effective strategy (PACE) to assist schools’ implementation of a physical activity policy. Specifically, it aimed to determine the probability that a multi-strategy intervention adapted to reduce in-person contact (Adapted PACE) was “as good as” the original intervention (PACE) in increasing the weekly minutes of structured physical activity implemented by classroom teachers. Methods A noninferiority cluster randomised controlled trial was undertaken with 48 primary schools in New South Wales, Australia. Schools were randomised to receive PACE or a model with adaptations made to the delivery modes (Adapted PACE). Teachers’ scheduled minutes of weekly physical activity was assessed at baseline (Oct 2018-Feb 2019) and 12-month follow-up (Oct-Dec 2019). The noninferiority margin was set at − 16.4 minutes based on previous data and decision panel consensus. A linear mixed model analysed within a Bayesian framework was used to explore noninferiority between the two PACE models. A cost minimisation analysis was conducted from the health service provider perspective, using the Australian dollar (AUD). Results The posterior estimate for the between group difference at follow-up was − 2.3 minutes (95% credible interval = − 18.02, 14.45 minutes). There was an estimated 96% probability of Adapted PACE being considered noninferior (only 4% of the posterior samples crossed the noninferiority margin of − 16.4 minutes). That is, the minutes of physical activity implemented by teachers at Adapted PACE schools was not meaningfully less than the minutes of physical activity implemented by teachers at PACE schools. The mean total cost was AUD$25,375 (95% uncertainty interval = $21,499, $29,106) for PACE and AUD$16,421 (95% uncertainty interval = $13,974, $19,656) for Adapted PACE; an estimated reduction of AUD$373 (95% uncertainty interval = $173, $560) per school. Conclusions It is highly probable that Adapted PACE is noninferior to the original model. It is a cost-efficient alternative also likely to be a more suitable approach to supporting large scale implementation of school physical activity policies. Trial registration Retrospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619001229167).
... Additionally, taking gender-sensitive intervention delivery, location and interventionists into account was shown to result in same/similar significant results for both boys and girls. For example, the included study of van Nassau et al. (2014) reported consideration sex/gender aspects regarding the person carrying out the intervention. In particular, all measurements of boys were done by male research assistants, whereas all measurements of girls were performed by female research assistants. ...
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Aim The main objectives of this systematic review were to evaluate the effects of interventions on leisure-time PA of boys and girls and to appraise the extent to which studies have taken sex/gender into account. Subject and methods PRISMA guidelines were followed. Two researchers independently screened studies for eligibility and assessed the risk of bias. Descriptive analyses were conducted to evaluate intervention effects in relation to the consideration of sex/gender in the studies based on a newly developed checklist. Additionally, meta-analyses were performed to determine the effect of interventions on girls’ and boys’ leisure-time PA. Results Overall 31 unique studies reported 44 outcomes on leisure-time PA and 20,088 participants were included in the current study. Consideration of sex/gender aspects in studies is low. PA outcomes with statistically significant same/similar effects in boys and girls showed higher quality of reporting sex/gender aspects of theoretical and/or conceptual linkages with sex/gender, measurement instruments, intervention delivery, location and interventionists and participant flow than PA outcomes without significant effects in both boys and girls or effects only in boys or girls. Interventions had a small but significant effect on girls (number of included studies (k) = 9, g = 0.220, p = .003) and boys (k = 7, g = 0.193, p = .020) leisure-time PA. Conclusion Higher reporting of sex/gender aspects may improve leisure-time PA of boys and girls. Nevertheless, there remains a need to address sufficient consideration of sex/gender aspects in interventions in the context of PA.
... The participatory approach is sparsely used in research when evaluating active lifestyle interventions among prevocational secondary education students [31,[40][41][42][43][44]. This is surprising, since the involvement of students in developing an intervention is considered an effective intervention characteristic [16]. ...
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The evidence-based Dutch Obesity Intervention in Teenagers (DOiT) program is a school-based obesity prevention program for 12 to 14-year olds attending the first two years of prevocational education. This paper describes the study protocol applied to evaluate (a) the nationwide dissemination process of DOiT in the Netherlands, and (b) the relationship between quality of implementation and effectiveness during nationwide dissemination of the program in the Netherlands. In order to explore facilitating factors and barriers for dissemination of DOiT, we monitored the process of adoption, implementation and continuation of the DOiT program among 20 prevocational schools in the Netherlands. The study was an education observational study using qualitative (i.e. semi-structured interviews) and quantitative methods (i.e. questionnaires and logbooks). Eight process indicators were assessed: recruitment, context, reach, dosage, fidelity, satisfaction, effectiveness and continuation. All teachers, students and parents involved in the implementation of the program were invited to participate in the study. As part of the process evaluation, a cluster-controlled trial with ten control schools was conducted to evaluate the effectiveness of the program on students' anthropometry and energy balance-related behaviours and its association with quality of implementation. The identified impeding and facilitating factors will contribute to an adjusted strategy promoting adoption, implementation and continuation of the DOiT program to ensure optimal use and, thereby, prevention of obesity in Dutch adolescents.Trial registration: Current Controlled Trials ISRCTN92755979.
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Publisher Summary There is considerable agreement about the importance of self-regulation to human survival. There is disagreement about how it can be analyzed and defined in a scientifically useful way. A social cognitive perspective differs markedly from theoretical traditions that seek to define self-regulation as a singular internal state, trait, or stage that is genetically endowed or personally discovered. Instead, it is defined in terms of context-specific processes that are used cyclically to achieve personal goals. These processes entail more than metacognitive knowledge and skill; they also include affective and behavioral processes, and a resilient sense of self-efficacy to control them. The cyclical interdependence of these processes, reactions, and beliefs is described in terms of three sequential phases: forethought, performance or volitional control, and self-reflection. An important feature of this cyclical model is that it can explain dysfunctions in self-regulation, as well as exemplary achievements. Dysfunctions occur because of the unfortunate reliance on reactive methods of self-regulation instead of proactive methods, which can profoundly change the course of cyclical learning and performance. An essential issue confronting all theories of self-regulation is how this capability or capacity can be developed or optimized. Social cognitive views place particular emphasis on the role of socializing agents in the development of self-regulation, such as parents, teachers, coaches, and peers. At an early age, children become aware of the value of social modeling experiences, and they rely heavily on them when acquiring needed skills.
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Background: The school-based Dutch Obesity Intervention in Teenagers (DOiT) program is an evidence-based obesity prevention program. In preparation for dissemination throughout the Netherlands, this study aimed to adapt the initial program and to develop an implementation strategy and materials. Methods: We revisited the Intervention Mapping (IM) protocol, using results of the previous process evaluation and additional focus groups and interviews with students, parents, teachers, and professionals. Results: The adapted 2-year DOiT program consists of a classroom, an environmental and a parental component. The year 1 lessons aim to increase awareness and knowledge of healthy behaviors. The lessons in year 2 focus on the influence of the (obesogenic) environment. The stepwise development of the implementation strategy resulted in objectives that support teachers' implementation. We developed a 7-step implementation strategy and supporting materials by translating the objectives into essential elements and practical strategies. Conclusions: This study illustrates how revisiting the IM protocol resulted in an adapted program and tailored implementation strategy based on previous evaluations as well as input from different stakeholders. The stepwise development of DOiT can serve as an example for other evidence-based programs in preparation for wider dissemination.