RESUMO
BACKGROUND: Physical activity (PA) can improve the physical and psychological health of prostate and colorectal cancer survivors, but PA behavior change maintenance is necessary for long-term health benefits. OncoActive is a print- and web-based intervention in which prostate and colorectal cancer patients and survivors receive automatically generated, personalized feedback aimed at integrating PA into daily life to increase and maintain PA. We evaluated the long-term outcomes of OncoActive by examining the 12-month follow-up differences between OncoActive and a control group, and we explored whether PA was maintained during a 6-month non-intervention follow-up period. METHODS: Prostate or colorectal cancer patients were randomly assigned to an OncoActive (n = 249) or a usual care waitlist control group (n = 229). OncoActive participants received PA advice and a pedometer. PA outcomes (i.e., ActiGraph and self-report moderate-to-vigorous intensity PA (MVPA) min/week and days with ≥30 min PA) and health-related outcomes (i.e., fatigue, depression, physical functioning) were assessed at baseline, 6 months, and 12 months. Differences between groups and changes over time were assessed with multilevel linear regressions for the primary outcome (ActiGraph MVPA min/week) and all additional outcomes. RESULTS: At 12 months, OncoActive participants did not perform better than control group participants at ActiGraph MVPA min/week, self-report MVPA min/week, or ActiGraph days with PA. Only self-report days with PA were significantly higher in OncoActive compared to the control group. For health-related outcomes only long-term fatigue was significantly lower in OncoActive. When exploratively examining PA within OncoActive, the previously found PA effects at the end of the intervention (6 months follow-up) were maintained at 12 months. Furthermore, all PA outcomes improved significantly from baseline to 12 months. The control group showed small but non-significant improvements from 6 months to 12 months (and from baseline to 12 months), resulting in a decline of differences between groups. CONCLUSION: The majority of previously reported significant between-group differences at 6 months follow-up were no longer present at long-term follow-up, possibly because of natural improvement in the control group. At long-term follow-up, fatigue was significantly lower in OncoActive compared to control group participants. Computer-tailored PA advice may give participants an early start toward recovery and potentially contributes to improving long-term health.
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Sobreviventes de Câncer , Neoplasias Colorretais , Masculino , Humanos , Próstata , Exercício Físico , Computadores , FadigaRESUMO
Vocational education and training (VET) educates students for a broad range of occupations, which may be associated with differences in habitual physical activity behavior (PAB). Research suggests that physical activity (PA) is positively and sedentary behavior (SB) is negatively associated with cognitive performance. Therefore, we aimed to compare habitual PAB in VET students from different educational tracks and investigate its association with cognitive performance in a cross-sectional study. Students wore an ActivPAL accelerometer continuously for seven days to measure PAB. Cognitive performance was assessed with objective tests for inhibition, shifting, and updating. Hairdresser and Sports students sat significantly less than Administrative and Nursing students. Hairdresser students stood significantly more than other tracks. Admin students stood significantly less than Sports/Nursing students. Sports students moved significantly more than Hairdresser and Nursing students. Time in bed was significantly lowest in Nursing students. No significant associations between any PAB and cognitive performance were found. In general, Admin students showed the unhealthiest habitual PAB. Higher PA or lower SB neither improve nor decrease cognitive performance. Thus, future health interventions focusing on exchanging SB for PA at schools can facilitate a healthier lifestyle of VET students, especially in Admin students, without interfering with cognitive performance.
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Estudantes , Educação Vocacional , Acelerometria , Cognição , Estudos Transversais , Exercício Físico , HumanosRESUMO
While it has been shown that interrupting a person's sedentary behaviour has the potential to improve cognitive, physical and mental health, a large part of time that students spend in school is sedentary. As research has shown that approximately 80% of vocational education and training (VET) students have an unhealthy sedentary lifestyle, implementing "sit-to-stand" (StS) desks could interrupt sedentary behaviour and promote healthier behaviour. Therefore, the acceptability and feasibility of using such desks in the VET setting should be investigated. Using semi-structured focus group interviews analysed via deductive content analysis, the opinions of 33 students for the following topics were assessed: (1) usage of the standing option of the desks (2) reasons for standing in class (3) experienced effect of standing behind the desk, and (4) fostering future StS desks usage. Although VET students are aware of the potential benefits of using StS desks, they need to be actively stimulated and motivated by teachers to use them. In addition, time is needed to get into the habit of standing. Thus, for successful implementation of StS desks in the VET setting, all stakeholders (i.e., students, teachers, schoolboards) should be actively involved in stimulating the healthy behaviour of VET students.
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Decoração de Interiores e Mobiliário , Educação Vocacional , Estudos de Viabilidade , Humanos , Comportamento Sedentário , Posição Ortostática , Local de TrabalhoRESUMO
Objective: To provide insight into the motivational working mechanisms (i.e. mediators) of an effective physical activity (PA) intervention for adults aged over fifty.Design: The mediation model (N = 822) was investigated in an RCT for the total intervention population, participants who were not norm-active at baseline (targeting PA initiation) and norm-active participants (targeting PA maintenance) separately.Main Outcome Measures: Potential mediators (attitude, self-efficacy, intention, action planning and coping planning) of the effect on PA (6-months) were assessed at baseline, 3 and/or 6 months.Results: The intervention resulted in a decrease in intention (B= -.209; p=.017), and an increase in action planning (B=.214; p=.018) and PA (B=.220; p=.002). Intention and action planning did not mediate the effect on PA. Self-efficacy, although not significantly influenced by the intervention, was found to be the only motivational variable that predicted change in PA (B=.164; p=.007). These results were confirmed among participants initiating PA. Among norm-active participants no significant intervention effects were identified.Conclusion: The motivational factors cannot explain the intervention effect on PA. Most likely, the effect can be explained by an interaction between the motivational factors together. Differences between participants initiating versus maintaining PA, highlight the importance of performing mediation analyses per subgroup.
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Exercício Físico/psicologia , Promoção da Saúde/métodos , Motivação , Idoso , Feminino , Humanos , Intenção , Masculino , Pessoa de Meia-Idade , AutoeficáciaRESUMO
BACKGROUND: Physical activity (PA) is beneficial in improving negative physical and psychological effects of cancer and cancer treatment, but adherence to PA guidelines is low. Computer-tailored PA interventions can reach large populations with little resources. They match with patients' preference for home-based, unsupervised PA programs and are thus promising for the growing population of cancer survivors. The current study assessed the efficacy of a computer-tailored PA intervention in (four subgroups of) prostate and colorectal cancer survivors. METHODS: Prostate and colorectal cancer patients and survivors were randomized to the OncoActive intervention group (N = 249), or a usual-care waiting-list control group (N = 229). OncoActive participants received a pedometer and computer-tailored PA advice, both Web-based via an interactive website and with printed materials. Minutes moderate-to-vigorous PA (MVPA) and days ≥30 min PA were assessed with an accelerometer (ActiGraph) at baseline and 6 months. Further, questionnaires were used to assess self-reported PA, fatigue, distress, and quality of life at baseline, 3 and 6 months. Differences between both groups were assessed using linear regression analyses (complete cases and intention-to-treat). In addition, efficacy in relation to age, gender, education, type of cancer, and time since treatment was examined. RESULTS: Three months after baseline OncoActive participants significantly increased their self-reported PA (PA days: d = 0.46; MVPA: d = 0.23). Physical functioning (d = 0.23) and fatigue (d = - 0.21) also improved significantly after three months. Six months after baseline, self-reported PA (PA days: d = 0.51; MVPA: d = 0.37) and ActiGraph MVPA (d = 0.27) increased significantly, and ActiGraph days (d = 0.16) increased borderline significantly (p = .05; d = 0.16). Furthermore, OncoActive participants reported significantly improvements in physical functioning (d = 0.14), fatigue (d = - 0.23) and depression (d = - 0.32). Similar results were found for intention-to-treat analyses. Higher increases in PA were found for colorectal cancer participants at 3 months, and for medium and highly educated participants' PA at 6 months. Health outcomes at 6 months were more prominent in colorectal cancer participants and in women. CONCLUSIONS: The OncoActive intervention was effective at increasing PA in prostate and colorectal cancer patients and survivors. Health-related effects were especially apparent in colorectal cancer participants. The intervention provides opportunities to accelerate cancer recovery. Long-term follow-up should examine further sustainability of these effects. TRIAL REGISTRATION: The study was registered in the Dutch Trial Register ( NTR4296 ) on October 17 2018.
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Sobreviventes de Câncer , Neoplasias Colorretais/terapia , Terapia por Exercício , Neoplasias da Próstata/terapia , Actigrafia , Idoso , Depressão/terapia , Fadiga/terapia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Tamanho da Amostra , Fatores Socioeconômicos , Inquéritos e Questionários , Resultado do TratamentoRESUMO
BACKGROUND: Physical activity (PA) is beneficial in improving negative physical and psychological effects of cancer. The rapidly increasing number of cancer survivors, resulting from aging and improved cancer care, emphasizes the importance to develop and provide low cost, easy accessible PA programs. Such programs could be provided through the Internet, but that could result in the exclusion of cancer survivors not familiar with the Internet. Therefore, we developed a computer-tailored PA intervention for prostate and colorectal cancer survivors in which both Web-based and print materials are provided, and participants can choose their own preferred delivery mode. OBJECTIVE: The aim of this study was to assess participants' characteristics related to delivery mode and use of intervention materials. METHODS: We studied characteristics of participants using Web-based and printed intervention materials in a randomized controlled trial (RCT). Prostate and colorectal cancer survivors recruited from hospitals were randomized to OncoActive (computer-tailored PA intervention) or a usual-care control group. OncoActive participants received both Web-based and printed materials. Participants were classified into initial print- or Web-based participants based on their preferred mode of completion of the first questionnaire, which was needed for the computer-tailored PA advice. Intervention material use during the remainder of the intervention was compared for initial print- or Web-based participants. Additionally, participants were classified into those using only print materials and those using Web-based materials. Differences in participant characteristics and intervention material use were studied through analysis of variance (ANOVAs), chi-square tests, and logistic regressions. RESULTS: The majority of the participants in the intervention group were classified as initial Web-based participants (170/249, 68.3%), and 84.9% (191/249) used Web-based intervention materials. Dropout was low (15/249, 6.0%) and differed between initial Web-based (4/170, 2.4%) and print-based (11/79, 14%) participants. Participants were less likely to start Web-based with higher age (odds ratio [OR]=0.93), longer time since last treatment (OR=0.87), and higher fatigue (OR=0.96), and more likely with higher education (OR=4.08) and having completed treatments (OR=5.58). Those who were older (OR=0.93) and post treatment for a longer time (OR=0.86) were less likely to use Web-based intervention materials. Initial print-based participants predominantly used print-based materials, whereas initial Web-based participants used both print- and Web-based materials. CONCLUSIONS: To our knowledge, this is one of the first studies that assessed participant characteristics related to delivery mode in an intervention in which participants had a free choice of delivery modes. Use of print-based materials among the initial Web-based participants was substantial, indicating the importance of print-based materials. According to our findings, it may be important to offer Web- and print-based materials alongside each other. Providing Web-based materials only may exclude older, less educated, more fatigued, or currently treated participants; these groups are especially more vulnerable and could benefit most from PA interventions.
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Sobreviventes de Câncer/educação , Neoplasias Colorretais/terapia , Computadores/estatística & dados numéricos , Exercício Físico/fisiologia , Internet/estatística & dados numéricos , Neoplasias da Próstata/terapia , Idoso , Feminino , Humanos , Masculino , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Physical inactivity is a significant predictor of several chronic diseases, becoming more prevalent as people age. Since the aging population increases demands on healthcare budgets, effectively stimulating physical activity (PA) against acceptable costs is of major relevance. This study provides insight into long-term health outcomes and cost-effectiveness of a tailored PA intervention among adults aged over fifty. METHODS: Intervention participants (N = 1729) received tailored advice three times within four months, targeting the psychosocial determinants of PA. The intervention was delivered in different conditions (i.e. print-delivered versus Web-based, and with or without additional information on local PA opportunities). In a clustered RCT, the effects of the different intervention conditions were compared to each other and to a control group. Effects on weekly Metabolic Equivalents (MET)-hours of PA obtained one year after the intervention started were extrapolated to long-term outcomes (5-year, 10-year and lifetime horizons) in terms of health effects and quality-adjusted life years (QALYs) and its effect on healthcare costs, using a computer simulation model. Combining the model outcomes with intervention cost estimates, this study provides insight into the long-term cost-effectiveness of the intervention. Incremental cost-effectiveness ratios (ICERs) were calculated. RESULTS: For all extrapolated time horizons, the printed and the Web-based intervention resulted in decreased incidence numbers for diabetes, colon cancer, breast cancer, acute myocardial infarctions, and stroke and increased QALYs as a result of increased PA. Considering a societal Willingness-to-Pay of 20,000/QALY, on a lifetime horizon the printed (ICER = 7,500/QALY) as well as the Web-based interventions (ICER = 10,100/QALY) were cost-effective. On a 5-year time horizon, the Web-based intervention was preferred over the printed intervention. On a 10-year and lifetime horizon, the printed intervention was the preferred intervention condition, since the monetary savings of the Web-based intervention did no longer outweigh its lower effects. Adding environmental information resulted in a lower cost-effectiveness. CONCLUSION: A tailored PA intervention in a printed delivery mode, without environmental information, has the most potential for being cost-effective in adults aged over 50. TRIAL REGISTRATION: The current study was registered at the Dutch Trial Register (NTR2297; April 26th 2010).
Assuntos
Doenças Cardiovasculares/prevenção & controle , Diabetes Mellitus/prevenção & controle , Custos de Cuidados de Saúde , Internet , Atividade Motora , Neoplasias/prevenção & controle , Comportamento de Redução do Risco , Terapia Assistida por Computador/economia , Idoso , Doenças Cardiovasculares/economia , Simulação por Computador , Análise Custo-Benefício , Diabetes Mellitus/economia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Neoplasias/economia , Anos de Vida Ajustados por Qualidade de VidaRESUMO
BACKGROUND: The adverse health effects of insufficient physical activity (PA) result in high costs to society. The economic burden of insufficient PA, which increases in our aging population, stresses the urgency for cost-effective interventions to promote PA among older adults. The current study provides insight in the cost-effectiveness and cost-utility of different versions of a tailored PA intervention (Active Plus) among adults aged over fifty. METHODS: The intervention conditions (i.e. print-delivered basic (PB; N = 439), print-delivered environmental (PE; N = 435), Web-based basic (WB; N = 423), Web-based environmental (WE; N = 432)) and a waiting-list control group were studied in a clustered randomized controlled trial. Intervention costs were registered during the trial. Health care costs, participant costs and productivity losses were identified and compared with the intervention effects on PA (in MET-hours per week) and quality-adjusted life years (QALYs) 12 months after the start of the intervention. Cost-effectiveness ratios (ICERs) and cost-utility ratios (ICURs) were calculated per intervention condition. Non-parametric bootstrapping techniques and sensitivity analyses were performed to account for uncertainty. RESULTS: As a whole (i.e. the four intervention conditions together) the Active Plus intervention was found to be cost-effective. The PB-intervention (ICER = -55/MET-hour), PE-intervention (ICER = -94/MET-hour) and the WE-intervention (ICER = -139/MET-hour) all resulted in higher effects on PA and lower societal costs than the control group. With regard to QALYs, the PB-intervention (ICUR = 38,120/QALY), the PE-intervention (ICUR = 405,892/QALY) and the WE-intervention (ICUR = -47,293/QALY) were found to be cost-effective when considering a willingness-to-pay threshold of 20,000/QALY. In most cases PE had the highest probability to be cost-effective. CONCLUSIONS: The Active Plus intervention was found to be a cost-effective manner to increase PA in a population aged over fifty when compared to no-intervention. The tailored Active Plus intervention delivered through printed material and with additional environmental information (PE) turned out to be the most cost-effective intervention condition as confirmed by the different sensitivity analyses. By increasing PA at relatively low costs, the Active Plus intervention can contribute to a better public health. TRIAL REGISTRATION: Dutch Trial Register: NTR2297.
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Análise Custo-Benefício , Promoção da Saúde/economia , Internet/economia , Atividade Motora , Idoso , Análise por Conglomerados , Feminino , Seguimentos , Custos de Cuidados de Saúde , Humanos , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Estudos Retrospectivos , Sensibilidade e EspecificidadeRESUMO
The public health impact of health behaviour interventions is highly dependent on large-scale implementation. Intermediaries-intervention providers-determine to a large extent whether an intervention reaches the target population, and hence its impact on public health. A cross-sectional study was performed to identify the correlates of intermediaries' intention to implement a computer-tailored physical activity intervention. According to theory, potential correlates are intervention characteristics, organisational characteristics, socio-political characteristics and intermediary characteristics. This study investigated whether intermediary characteristics mediated the association between the intervention, organisational and socio-political characteristics and intention to implement the intervention. Results showed that intervention characteristics (i.e., observability (B = 0.53; p = 0.006); relative advantage (B = 0.79; p = 0.020); complexity (B = 0.80; p < 0.001); compatibility (B = 0.70; p < 0.001)), organisational characteristics (i.e., type of organization (B = 0.38; p = 0.002); perceived task responsibility (B = 0.66; p ≤ 0.001); capacity (B = 0.83; p < 0.001)), and the social support received by intermediary organisations (B = 0.81; p < 0.001) were associated with intention to implement the intervention. These factors should thus be targeted by an implementation strategy. Since self-efficacy and social norms perceived by the intermediary organisations partially mediated the effects of other variables on intention to implement the intervention (varying between 29% and 84%), these factors should be targeted to optimise the effectiveness of the implementation strategy.
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Exercício Físico/psicologia , Intenção , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
BACKGROUND: This study provides insight into the long-term efficacy (i.e. 12 month results) of the Web-based or print-delivered tailored Active Plus intervention (with and without environmental approach) to promote physical activity (PA) among the over-fifties. Differences in effect among subgroups are studied as well. METHODS: Intervention groups (i.e. print-delivered basic (PB; N = 439), print-delivered environmental (PE; N = 435), Web-based basic (WB; N = 423), Web-based environmental (WE; N = 432)) and a waiting list control group (N = 411) were studied in a clustered randomized controlled trial. Intervention participants received tailored advice three times within 4 months. Long-term effects (12 months after the intervention has started, i.e. 8 months after the intervention was completed) on PA (i.e. self-reported weekly minutes and days of sufficient PA) were tested using multilevel linear regression analyses. Participants' age, gender, BMI, educational level, PA intention and the presence of a chronic physical limitation were considered to be potential moderators of the effect. RESULTS: Overall, the Active Plus intervention was effective in increasing weekly days of sufficient PA (B=0.49; p=.005), but ineffective in increasing weekly minutes of PA (B=84.59; p=.071). Per intervention condition analysis showed that the PB-intervention (B(days)=0.64; p=.002; B(min)=111.36; p=.017) and the PE-intervention (B(days)=0.70; p=.001; B(min)=157.41; p=.001) were effective in increasing days and minutes of PA. Neither Web-based conditions significantly increased PA, while the control group decreased their PA. In contrast to the intervention effect on minutes of PA, the effect on weekly days of PA was significantly moderated by the participants' baseline intention to be sufficiently physically active. CONCLUSIONS: In general, after 12 months the print-delivered interventions resulted in stronger effects than the Web-based interventions. The participants' baseline intention was the only significant moderator of the intervention effect. All other assessed user characteristics did not significantly moderate the effect of the intervention, which might indicate that the intervention is sufficiently tailored to the different participant characteristics. Additional efforts should be taken to increase the sustainability of Web-based interventions. TRIAL REGISTRATION: Dutch Trial Register: NTR2297.
Assuntos
Comportamentos Relacionados com a Saúde , Promoção da Saúde/métodos , Internet , Atividade Motora/fisiologia , Idoso , Análise por Conglomerados , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Fatores Socioeconômicos , Inquéritos e Questionários , TempoRESUMO
BACKGROUND: The Internet has the potential to provide large populations with individual health promotion advice at a relatively low cost. Despite the high rates of Internet access, actual reach by Web-based interventions is often disappointingly low, and differences in use between demographic subgroups are present. Furthermore, Web-based interventions often have to deal with high rates of attrition. OBJECTIVE: This study aims to assess user characteristics related to participation and attrition when comparing Web-based and print-delivered tailored interventions containing similar content and thereby to provide recommendations in choosing the appropriate delivery mode for a particular target audience. METHODS: We studied the distribution of a Web-based and a print-delivered version of the Active Plus intervention in a clustered randomized controlled trial (RCT). Participants were recruited via direct mailing within the participating Municipal Health Council regions and randomized to the printed or Web-based intervention by their region. Based on the answers given in a prior assessment, participants received tailored advice on 3 occasions: (1) within 2 weeks after the baseline, (2) 2 months after the baseline, and (3) within 4 months after the baseline (based on a second assessment at 3 months). The baseline (printed or Web-based) results were analyzed using ANOVA and chi-square tests to establish the differences in user characteristics between both intervention groups. We used logistic regression analyses to study the interaction between the user characteristics and the delivery mode in the prediction of dropout rate within the intervention period. RESULTS: The printed intervention resulted in a higher participation rate (19%) than the Web-based intervention (12%). Participants of the Web-based intervention were significantly younger (P<.001), more often men (P=.01), had a higher body mass index (BMI) (P=.001) and a lower intention to be physically active (P=.03) than participants of the printed intervention. The dropout rate was significantly higher in the Web-based intervention group (53%) compared to the print-delivered intervention (39%, P<.001). A low intention to be physically active was a strong predictor for dropout within both delivery modes (P<.001). The difference in dropout rate between the Web-based and the printed intervention was not explained by user characteristics. CONCLUSIONS: The reach of the same tailored physical activity (PA) intervention in a printed or Web-based delivery mode differed between sociodemographic subgroups of participants over 50 years of age. Although the reach of the Web-based intervention is lower, Web-based interventions can be a good channel to reach high-risk populations (lower PA intention and higher BMI). While the dropout rate was significantly higher in the Web-based intervention group, no specific user characteristics explained the difference in dropout rates between the delivery modes. More research is needed to determine what caused the high rate of dropout in the Web-based intervention. TRIAL REGISTRATION: Dutch Trial Register (NTR): 2297: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2297 (Archived by WebCite at http://www.webcitation.org/65TkwoESp).
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Internet , Humanos , Pessoa de Meia-IdadeRESUMO
BACKGROUND: The Active Plus project is a systematically developed theory- and evidence-based, computer-tailored intervention, which was found to be effective in changing physical activity behavior in people aged over 50 years. The process and effect outcomes of the first version of the Active Plus project were translated into an adapted intervention using the RE-AIM framework. The RE-AIM model is often used to evaluate the potential public health impact of an intervention and distinguishes five dimensions: reach, effectiveness, adoption, implementation, and maintenance. OBJECTIVE: To gain insight into the systematic translation of the first print-delivered version of the Active Plus project into an adapted (Web-based) follow-up project. The focus of this study was on the reach and effectiveness dimensions, since these dimensions are most influenced by the results from the original Active Plus project. METHODS: We optimized the potential reach and effect of the interventions by extending the delivery mode of the print-delivered intervention into an additional Web-based intervention. The interventions were adapted based on results of the process evaluation, analyses of effects within subgroups, and evaluation of the working mechanisms of the original intervention. We pretested the new intervention materials and the Web-based versions of the interventions. Subsequently, the new intervention conditions were implemented in a clustered randomized controlled trial. RESULTS: Adaptations resulted in four improved tailoring interventions: (1) a basic print-delivered intervention, (2) a basic Web-based intervention, (3) a print-delivered intervention with an additional environmental component, and (4) a Web-based version with an additional environmental component. Pretest results with participants showed that all new intervention materials had modest usability and relatively high appreciation, and that filling in an online questionnaire and performing the online tasks was not problematic. We used the pretest results to improve the usability of the different interventions. Implementation of the new interventions in a clustered randomized controlled trial showed that the print-delivered interventions had a higher response rate than the Web-based interventions. Participants of both low and high socioeconomic status were reached by both print-delivered and Web-based interventions. CONCLUSIONS: Translation of the (process) evaluation of an effective intervention into an adapted intervention is challenging and rarely reported. We discuss several major lessons learned from our experience. TRIAL REGISTRATION: Nederlands Trial Register (NTR): 2297; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2297 (Archived by WebCite at http://www.webcitation.org/65TkwoESp).