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To use theory to design and evaluate an intervention to promote sleep hygiene and health among adolescents. The Theory of Planned Behavior (TPB) and the Health Action Process Approach (HAPA) were used to develop an intervention, which was then evaluated in a cluster randomized trial. Participants were high school students (N = 2,841, M age = 15.12, SD = 1.50). Adolescents in the intervention group received four face-to-face sessions providing behavior change techniques targeting the theoretical determinants of sleep hygiene. Adolescents in the control group only received educational material at the end of the study. The primary outcome was sleep hygiene measured at 1 and 6 months postintervention. A number of secondary outcomes were also measured, including beliefs about sleep, self-regulatory processes, and outcomes related to health and wellbeing. Sleep hygiene was improved in the intervention group when compared with the control group at both follow-up points (coefficients = 0.16 and 0.19, 95% CIs = 0.12-0.20 and 0.15-0.23 at 1 and 6 months, respectively, for scores on the Adolescent Sleep Hygiene Scale), as were psychosocial and general aspects of health. Mediation analyses suggested that beliefs about sleep hygiene as specified by the TPB, along with self-regulatory processes from HAPA, both mediated the effect of the intervention on outcomes. In turn, the effects of the intervention on sleep hygiene mediated its impact on general health. Healthcare practitioners might consider intervention programs based on the TPB and the HAPA to improve sleep among adolescents. Clinicaltrials.gov (NCT02551913) https://clinicaltrials.gov/ct2/show/NCT02551913.

We conducted a critical review of the article “Effects on Children’s Physical and Mental Well-Being of a Physical-Activity-Based School Intervention Program: A Randomized Study”, published in the International Journal of Environmental Research and Public Health in 2023 as part of the Special Issue “Psychomotricity and Physical Education in School Health”. We identified multiple mistakes in the statistical analyses applied. First, the authors claim to have found a statistically significant association between the proposed intervention and change in body composition (body mass index (BMI) percentiles, relative fat mass, and BMI classes) by way of exhibiting differences in nominal significance between the pre- and post-intervention changes within the control and intervention groups, instead of exhibiting a significant difference between groups. Furthermore, the analysis described fails to account for clustering and nesting in the data. The reporting of the statistical methods and results include multiple elements that are variously incorrect, incoherent, or impossible. Revised statistical analyses are proposed which can render the study’s methods valid and its results substantiated, whereas the current methods and results are invalid and unsubstantiated, respectively.

Cluster randomization trials with relatively few clusters have been widely used in recent years for evaluation of health-care strategies. On average, randomized treatment assignment achieves balance in both known and unknown confounding factors between treatment groups, however, in practice investigators can only introduce a small amount of stratification and cannot balance on all the important variables simultaneously. The limitation arises especially when there are many confounding variables in small studies. Such is the case in the INSTINCT trial designed to investigate the effectiveness of an education program in enhancing the tPA use in stroke patients. In this article, we introduce a new randomization design, the balance match weighted (BMW) design, which applies the optimal matching with constraints technique to a prospective randomized design and aims to minimize the mean squared error (MSE) of the treatment effect estimator. A simulation study shows that, under various confounding scenarios, the BMW design can yield substantial reductions in the MSE for the treatment effect estimator compared to a completely randomized or matched-pair design. The BMW design is also compared with a model-based approach adjusting for the estimated propensity score and Robins-Mark-Newey E-estimation procedure in terms of efficiency and robustness of the treatment effect estimator. These investigations suggest that the BMW design is more robust and usually, although not always, more efficient than either of the approaches. The design is also seen to be robust against heterogeneous error. We illustrate these methods in proposing a design for the INSTINCT trial.

Background Hypertension affects one billion people globally and is one of the leading risk factors for cardiovascular and renal diseases. However, hypertension management remains poor, especially in rural China. Methods A clustered randomized controlled trial was conducted in six towns in China’s Qianjiang county between 7/2012 and 6/2014, including 5462 hypertension patients above 35 years old. Six towns were randomly assigned to three groups: Group 1 had the integrated care model including a multidisciplinary team and continuous care coordination, Group 2 had both the integrated care model and provider-level financial incentives, and the control group had the usual care. Primary outcomes were systolic blood pressure and health-related quality of life measured by SF36; secondary outcomes included hypertension-related hospitalization rate and inpatient spending. Blood pressure was measured sixteen times bimonthly between 12/1/2011 and 6/30/2014, and quality of life was measured on 7/1/2012 and 6/30/2014. Inpatient data between 7/1/2010 and 8/31/2014 were used. This trial is registered at the World Health Organization’s International Clinical Trials Registry, number ChiCTR-OOR-14005563. Results We found that the integrated care model effectively lowered blood pressure by 1.93 mmHg (95% CI 0.063–3.8), improved self-assessed health-related quality of life, and reduced the rate of hypertension-related hospitalization by 0.17 percentage points (95% CI 0.094–0.24). We also found that the provider-level financial contract further lowered blood pressure by 1.76 mmHg (95% CI 0.73–2.79) and reduced rates of hospitalization and inpatient spending, but it also reduced patients’ self-assessed health-related quality of life. Conclusions Integrated care and financial incentives are effective in lowering blood pressure and reducing hospitalization rate, but financial contracts may hurt patient quality of life. This trial was registered at the Chinese Clinical Trial Registry (ChiCTR-OOR-14005563) on November 23, 2014. It was a retrospective registration.

Purpose: A clustered-randomized controlled trial was conducted to determine the effects of a sodium reduction program in 120 rural villages in Northern China. This mixed-methods process evaluation was used to investigate the implementation and to evaluate the feasibility of the complex intervention to translate the findings from clinical study to the real world. Methods: A convergent mixed-methods process evaluation design was used in this study. Quantitative data were collected from activity logs and routine study records. Qualitative data were collected from 53 project stakeholders and 45 villagers from 10 intervention villages. Thematic analysis of qualitative interviews facilitated integration with the descriptive quantitative data analysis based on theory-informed domains of fidelity, delivery, reach, receipt, and contextual factors of intervention from a process evaluation framework. Results: The intervention was implemented with high fidelity, delivery, reach, and receipt. A total of 5,450 sheets of posters, 31,400 calendars, and 78,000 sheets of stickers were delivered as planned, and 11 promotion activities were conducted in each village. Contextual factors hindering full uptake of the intervention included preference for salty taste, higher cost of low-sodium salt, and low education levels of villagers. Other contextual factors, positive policy support, administrative support, and staff enthusiasm were the facilitators for implementation. Conclusions: This multifaceted intervention was implemented well and effectively in rural China. This process evaluation has indicated that conducting health education interventions in rural areas requires policy and administrative support, enthusiastic staff, easy-to-understand health education materials and activities, and key persons, but tempered expectations as behavior change requires time. This project demonstrates the feasibility and benefits of using mixed-methods process evaluation in large-scale studies.

Background Due to identifiability problems, statistical inference about treatment-by-period interactions has not been discussed for stepped wedge designs in the literature thus far. Unidirectional switch designs (USDs) generalize the stepped wedge designs and allow for estimation and testing of treatment-by-period interaction in its many flexible design forms. Methods Under different forms of the USDs, we simulated binary data at both aggregated and individual levels and studied the performances of the generalized linear mixed model (GLMM) and the marginal model with generalized estimation equations (GEE) for estimating and testing treatment-by-period interactions. Results The parallel group design had the highest power for detecting the treatment-by-period interactions. While there was no substantial difference between aggregated-level and individual-level analysis, the GLMM had better point estimates than the marginal model with GEE. Furthermore, the optimal USD for estimating the average treatment effect was not efficient for treatment-by-period interaction and the marginal model with GEE required a substantial number of clusters to yield unbiased estimates of the interaction parameters when the correlation structure is autoregressive of order 1 (AR1). On the other hand, marginal model with GEE had better coverages than GLMM under the AR1 correlation structure. Conclusion From the designs and methods evaluated, in general, parallel group design with a GLMM is, preferred for estimation and testing of treatment-by-period interaction in a clustered randomized controlled trial for a binary outcome.

Cluster randomized trials with relatively few clusters have been widely used in recent years for evaluation of health‐care strategies. The balance match weighted (BMW) design, introduced in Xu and Kalbfleisch (2010, Biometrics 66, 813–823), applies the optimal full matching with constraints technique to a prospective randomized design with the aim of minimizing the mean squared error (MSE) of the treatment effect estimator. This is accomplished through consideration of M independent randomizations of the experimental units and then selecting the one which provides the most balance evaluated by matching on the estimated propensity scores. Often in practice, clinical trials may involve more than two treatment arms and multiple treatment options need to be evaluated. Therefore, we consider extensions of the BMW propensity score matching method to allow for studies with three or more arms. In this article, we propose three approaches to extend the BMW design to clinical trials with more than two arms and evaluate the property of the extended design in simulation studies.

Staff working in residential care homes (RCHs) have played a significant role in preventing the spread of infection among residents, visitors, and staff. Providing continuous professional training to the staff is essential. Current infection control training mostly rests on short educational talks or one-to-one reminders in the RCHs. A blended mode of online interactive games and face-to-face consultations was now proposed as a new way to conduct infection control training in the RCHs. This study aims to assess the efficacy of the Blended Gaming COVID-19 Training System (BGCTS) on infection control practices and self-reported knowledge, attitude, and practices of standard precautions among health care workers in RCHs. A 2-arm, single-blinded, parallel cluster randomized controlled trial was designed, and 30 RCHs were recruited and randomized into an intervention group to receive the BGCTS and a control group to receive usual care on infection control training. Due to the COVID-19 pandemic and infected cases in the homes, 17 RCHs refused or delayed the on-site observations. The BGCTS intervention, developed based on \"The COVID-19 Risk Communication Package for Healthcare Facilities\" of the World Health Organization, consists of two parts: (1) an eHealth mode of a 120-minute web-based training system covering 8 topics, delivered in short-clip videos and games, and (2) two 30-minute face-to-face interactive sessions for concept clarification. The 2 infection control practices, \"use of gloves and personal protective equipment (PPE) and performing respiratory hygiene\" and \"hand rub,\" were assessed by on-site unobtrusive observations, and self-reported infection control practices and knowledge and attitude toward infection control were measured via online survey post intervention. A total of 212 staff from 13 RCHs were involved in the analysis, with 7 RCHs from the intervention group (n=114) and 6 RCHs from the control group (n=98). A significantly greater increase in the proportions of proper use of gloves and PPE and respiratory hygiene performance (β=.195, 95% CI 0.046-0.344; P=.02) and properly performed hand rub (β=.068, 95% CI 0.005-0.132; P=.04) was observed in the intervention group. The changes in the self-reported outcomes were not statistically significant. BGCTS improved RCH staff's performance in 2 infection control practices by objective measurement, \"gloves and PPE use and performance in respiratory hygiene\" and \"hand rub.\" BGCTS was shown to be an effective training, although it was a 2-week intervention. The BGCTS did not perform better than infection control briefing sessions in self-reported infection control knowledge, attitude, and practices. This electronic-based infection control training with 2 intensive interactive sessions has good potential to be adopted as regular training in RCHs. Clinicaltrials.gov NCT04783025; http://clinicaltrials.gov/ct2/show/NCT04783025.

Background DOLCE (Improving Decision making On Location of Care with the frail Elderly and their caregivers) was a post-intervention clustered randomised trial (cRT) to assess the effect of training home care teams on interprofessional shared decision-making (IP-SDM). Alongside the cRT, we sought to monitor healthcare providers’ level of behavioural intention to engage in an IP-SDM approach and to identify factors associated with this intention. Methods We conducted two cross-sectional surveys in the province of Quebec, Canada, one each at cRT entry and exit. Healthcare providers (e.g. nurses, occupational therapists and social workers) in the 16 participating intervention and control sites self-completed an identical paper-based questionnaire at entry and exit. Informed by the Integrated model for explaining healthcare professionals’ clinical behaviour by Godin et al. (2008), we assessed their behavioural intention to engage in IP-SDM to support older adults and caregivers of older adults with cognitive impairment to make health-related housing decisions. We also assessed psychosocial variables underlying their behavioural intention and collected sociodemographic data. We used descriptive statistics and linear mixed models to account for clustering. Results Between 2014 and 2016, 271 healthcare providers participated at study entry and 171 at exit. At entry, median intention level was 6 in a range of 1 (low) to 7 (high) (Interquartile range (IQR): 5–6.5) and factors associated with intention were social influence (β = 0.27, P  <  0.0001), beliefs about one’s capabilities (β = 0.43, P  <  0.0001), moral norm (β = 0.31, P  <  0.0001) and beliefs about consequences (β = 0.21, P  <  0.0001). At exit, median intention level was 5.5 (IQR: 4.5–6.5). Factors associated with intention were the same but did not include moral norm. However, at exit new factors were kept in the model: working in rehabilitation (β = − 0.39, P  = 0.018) and working as a technician (β = − 0.41, P  = 0.069) (compared to as a social worker). Conclusion Intention levels were high but decreased from entry to exit. Factors associated with intention also changed from study entry to study exit. These findings may be explained by the major restructuring of the health and social care system that took place during the 2 years of the study, leading to rapid staff turnover and organisational disturbance in home care teams. Future research should give more attention to contextual factors and design implementation interventions to withstand the disruption of system- and organisational-level disturbances. Trial registration Clinicaltrials.gov ( NCT02244359 ). Registered on September 19th, 2014.

Background Afar region is one of the pastoralist dominated regions in Ethiopia. The region is characterized by a low contraceptive prevalence rate (CPR) of 5.4%. Lack of awareness of contraceptive use, husband objection and religious barriers are attributed to low CPR in the region. This study assessed the effect of community-based interventions for promoting family planning (FP) use among pastoralist communities in Ethiopia. Methods The study design was a three-arm, parallel, clustered randomized controlled trial (CRT). The three study arms were: (1) male involvement in family planning (FP) education; (2) women’s education on FP; and (3) control. A total of 33 clusters were randomized and allocated with a one-to-one ratio. Intervention components included (1) health education on FP to married women and men by faema leaders (a traditional community-based structure that serves as a social support group); (2) video-assisted message on FP; and (3) assisting the faema leader using health workers and health extension workers (HEWs). The intervention was given for a total of nine months. FP use and intentions were measured as outcome variables. In addition, a cluster-level summary considering a cluster effect analysis was performed. The result was presented with t.test, adjusted risks and its 95% confidence interval (CI). Results The proportion of FP use among the arms was 34% in the male involvement in FP education, 17.5% in women’s education on FP and 4.3% in the control. There was a positive change in the proportion of FP use in the male involvement in FP education and women’s education on FP arms with absolute risk (AR) of 0.29 (95% CI, 0.23,0.34) and 0.13 (95% CI,0.08,0.17), respectively, as compared to the control arm. Similarly, married women in the male involvement in FP education and women’s education on FP arms had 3.4 (2.48, 4.91) and 2.1 (1.50, 2.95) higher intention to use FP, respectively, as compared with the control arm. Conclusion The present study suggests that in such male-dominated pastoralist communities with more considerable religious barriers, the community-based health education mainly targeting males appears to be a promising strategy for improving FP use and intention to use FP. Trial registration ClinicalTrials.gov, NCT03450564, March, 2018.