Cluster-controlled Trial Research Articles

Based -evidence, an intervention study to improve sleep quality in awake adult ICU patients: a prospective, single-blind, clustered controlled trial

Based -evidence, an intervention study to improve sleep quality in awake adult ICU patients: a prospective, single-blind, clustered controlled trial

Effectiveness of a cognitive behavioural therapy (CBT)-based intervention for reducing anxiety among adolescents in the Colombo District, Sri Lanka: cluster randomized controlled trial

Anxiety disorders are found to be the most prevalent psychological problems among children and adolescents. Cognitive behaviour therapy (CBT) was found to be effective at reducing anxiety. The purpose of this study was to assess the effectiveness of a universal school-based intervention for reducing anxiety among Grade 9 schoolchildren. A randomized controlled cluster trial was conducted by randomly assigning 36 schools in the Colombo district in Sri Lanka into study and control arms, each comprising 18 schools with 360 students. The levels of anxiety, self-esteem and depression status were assessed using the validated Screen for Child Anxiety Related Disorders (SCARED) tool and the Rosenberg self-esteem scale, respectively, and the Depression, Anxiety and Stress Scale 21 (DASS-21) at baseline, after intervention, and after 3 months. A CBT-based universal intervention package was administered weekly by a trained teacher for eight weeks with a one-month self-practice period to a randomly selected Grade 9 class in each school in the study arm. The control arm received routine care. Anxiety and self-esteem scores and depression status were compared between the two arms after the intervention and at 3 months of follow-up using the generalized estimation equation (GEE), controlling for confounding and clustering. The nonresponse and loss to follow-up rates were < 1%. When comparing the study arm with the control arm using GEE, anxiety levels were significantly lower [β = (-0.096), 95% CI = (-0.005) − (-0.186), p = 0.038] at follow-up but not postintervention [β = (-0.024), 95% CI = 0.006 − (-0.055), p = 0.115]. There were no significant differences in depression status after intervention (OR = 0.257, 95% CI =0.052–1.286; p = 0.098) or follow-up (OR = 0.422, 95% CI 0.177–1.008; p = 0.052), and self-esteem significantly increased after intervention (β = 0.811, 95% CI = 0.314–1.309; p = 0.001) but not at follow-up [β=0.435, 95% CI=(-0.276)-1.145, p=0.231]. This study revealed that the universal package based on CBT is effective at reducing anxiety and improving self-esteem among adolescents. The trial registration number and date were SLCTR/2018/018 and 19th of June 2018 respectively.

Suicide awareness homophily in adolescent peer support networks: A Swiss cross-sectional social network analysis

ObjectiveSuicide awareness, encompassing knowledge, attitudes, and behaviors related to suicide, plays a critical role in primary suicide prevention, especially among adolescents. However, little is known about how perceived suicide awareness is apparent in peer support networks in this population. This study examined the presence of suicide awareness homophily in adolescent peer support networks. We also explored other patterns of homophily and identified factors associated with the in-degree popularity of adolescents. MethodsWe used baseline data from a non-randomized, cluster-controlled trial assessing the effectiveness of a universal suicide prevention intervention in Swiss secondary schools (n = 194). We assessed perceived suicide awareness, support networks (including in-degree popularity, i.e., receiving a high number of nominations as a supportive peer), and other covariates. Data were analyzed using social network analyses. ResultsWe found evidence of suicide awareness homophily in peer support networks, where adolescents with high suicide awareness were more likely to connect with peers having high suicide awareness (p < .001). The same applied to those with low suicide awareness (p < .001). Age also emerged as a significant homophily factor. Girls (p = .024) and adolescents with high instrumental social support (p = .008) were more likely to be popular in peer support networks. ConclusionsThis study highlighted the homophily of suicide awareness in peer support networks and the need to focus on strengthening peer support networks and promoting suicide awareness in adolescents, particularly for those with low suicide awareness. Future suicide prevention programs, including peer-led interventions, should consider these findings to better target vulnerable subgroups and reduce suicide-related disparities.

A Randomized Controlled Cluster Trial of an Obesity Prevention Program for Children with Special Health Care Needs: Methods and Implications.

Children with disabilities have higher prevalence estimates of obesity than typically developing children. The Healthy Caregivers-Healthy Children Phase 3 (HC3) project implemented an obesity prevention program adapted for children with special health care needs (CSHCN) that includes dietary intake and physical activity (PA) components. The primary outcome was a change in dietary intake, PA, and the body mass index (BMI) percentile. Ten childcare centers (CCCs) serving low-resource families with ≥30 2- to 5-year-olds attending were randomized to either the intervention (n = 5) or control (n = 5). The HC3 CCCs received (1) snack, beverage, PA, and screen time policies via weekly technical assistance; (2) adapted lesson plans for CSHCN; and (3) parent curricula. The control CCCs received a behavioral health attention curriculum. HC3 was delivered over three school years, with data collected at five different timepoints. It was delivered weekly for six months in year one. To ensure capacity building, the HC3 tasks were scaled back, with quarterly intervention delivery in year 2 and annually in year 3. Adaptations were made to the curriculum to ensure appropriate access for CSHCN. Given that the program was being delivered during the COVID-19 pandemic, special modifications were made to follow CDC safety standards. The primary outcome measures included the Environment and Policy Assessment and Observation (EPAO) tool, standardized dietary intake and PA assessments, and the child BMI percentile. CCCs are an ideal setting for targeting CSHCN for obesity prevention efforts as they provide an opportunity to address modifiable risk factors.

Pragmatic controlled trial of a school-based emotion literacy program for 8- to 10-year-old children: study protocol

BackgroundMental disorders are common in childhood, but many young people do not receive adequate professional support. Help-seeking interventions may bridge this treatment gap, however, there is limited research on interventions for primary-school children. This study aims to evaluate the effectiveness of an emotion literacy program at increasing literacy, reducing stigma, and promoting help-seeking in children aged 8–10 years.Methods and analysisA two-arm pragmatic cluster-controlled trial will compare Thriving Minds, an emotion literacy program for middle primary school children, to a wait-list control condition. Children aged 8–10 years will be recruited from approximately 12 schools (6 intervention schools/6 wait-list control) to participate in Thriving Minds via direct invitation by the program delivery service. Allocation to the intervention condition will be pragmatically, by school. Children will receive the intervention over two 50-minute sessions, across two weeks. Using story books and interactive discussion, the program aims to develop children’s knowledge of their own and other’s emotional experiences and emotion regulation strategies (self-care and help-seeking). The primary outcome is help-seeking intentions. Secondary outcomes include help-seeking knowledge, attitudes, and behaviours, emotion knowledge and attitudes, and stigma. Children will complete surveys at pre-intervention, post-intervention (one week after the program) and 12-week follow-up. Additional satisfaction data will be collected from teachers in intervention schools via surveys (post-intervention and 3-month follow-up) and semi-structured interviews (after follow-up), and selected children via focus groups (12-week follow-up). Analyses will compare changes in help-seeking intentions relative to the waitlist control condition using mixed-model repeated-measures analyses to account for clustering within schools.DiscussionWith demonstrated effectiveness, this universal emotion literacy program for promoting help-seeking for mental health could be more widely delivered in Australian primary schools, providing a valuable new resource, contributing to the mental health of young people by improving help-seeking for early mental health difficulties.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12623000910606 Registered on 24 August 2023.

Implementation of an Electronic Clinical Decision Support System for the Early Recognition and Management of Dysglycemia in an Inpatient Mental Health Setting Using CogStack: Protocol for a Pilot Hybrid Type 3 Effectiveness-Implementation Randomized Controlled Cluster Trial.

Severe mental illnesses (SMIs), including schizophrenia, bipolar affective disorder, and major depressive disorder, are associated with an increased risk of physical health comorbidities and premature mortality from conditions including cardiovascular disease and diabetes. Digital technologies such as electronic clinical decision support systems (eCDSSs) could play a crucial role in improving the clinician-led management of conditions such as dysglycemia (deranged blood sugar levels) and associated conditions such as diabetes in people with a diagnosis of SMI in mental health settings. We have developed a real-time eCDSS using CogStack, an information retrieval and extraction platform, to automatically alert clinicians with National Health Service Trust-approved, guideline-based recommendations for dysglycemia monitoring and management in secondary mental health care. This novel system aims to improve the management of dysglycemia and associated conditions, such as diabetes, in SMI. This protocol describes a pilot study to explore the acceptability, feasibility, and evaluation of its implementation in a mental health inpatient setting. This will be a pilot hybrid type 3 effectiveness-implementation randomized controlled cluster trial in inpatient mental health wards. A ward will be the unit of recruitment, where it will be randomly allocated to receive either access to the eCDSS plus usual care or usual care alone over a 4-month period. We will measure implementation outcomes, including the feasibility and acceptability of the eCDSS to clinicians, as primary outcomes, alongside secondary outcomes relating to the process of care measures such as dysglycemia screening rates. An evaluation of other implementation outcomes relating to the eCDSS will be conducted, identifying facilitators and barriers based on established implementation science frameworks. Enrollment of wards began in April 2022, after which clinical staff were recruited to take part in surveys and interviews. The intervention period of the trial began in February 2023, and subsequent data collection was completed in August 2023. Data are currently being analyzed, and results are expected to be available in June 2024. An eCDSS can have the potential to improve clinician-led management of dysglycemia in inpatient mental health settings. If found to be feasible and acceptable, then, in combination with the results of the implementation evaluation, the system can be refined and improved to support future successful implementation. A larger and more definitive effectiveness trial should then be conducted to assess its impact on clinical outcomes and to inform scalability and application to other conditions in wider mental health care settings. ClinicalTrials.gov NCT04792268; https://clinicaltrials.gov/study/NCT04792268. DERR1-10.2196/49548.

Effect of implementation strategies on the routine provision of antenatal care addressing smoking in pregnancy: study protocol for a non-randomised stepped-wedge cluster controlled trial

IntroductionGlobally, guideline-recommended antenatal care for smoking cessation is not routinely delivered by antenatal care providers. Implementation strategies have been shown to improve the delivery of clinical practices across a variety...

A digital Acceptance and Commitment Therapy and education intervention targeting stress of parents and caregivers with preterm babies in the neonatal intensive care unit: A randomised controlled cluster trial protocol

BackgroundParents with babies in the neonatal intensive care unit (NICU) experience high levels of stress, anxiety, and depression. The NICU experience may also lead to impaired parenting and early childhood socio-emotional problems.Psychosocial interventions can reduce NICU parent distress. Yet many are time-intensive and costly to deliver. Acceptance and Commitment Therapy (ACT), an evidence-based psychological therapy, may address these needs. ACT has been shown to be effective in reducing distress of parents of children with chronic illnesses, particularly when combined with parent education.Therefore, the primary aim of this study is to determine if a digital intervention that uses a brief form of ACT plus parent education will reduce the stress of primary caregivers with preterm babies in the NICU more than a digital education-only intervention or standard care control group. MethodsIn a randomised controlled cluster trial design, participants will be randomly assigned to one of three groups: ACT plus education; education-only; or standard care control. The primary outcome will be parental/caregiver stress levels, measured on the Parental Stress Scale: Neonatal Intensive Care Unit. Secondary outcomes include overall stress, anxiety, and depression. Outcome measures will be evaluated at baseline, two weeks after enrolment, discharge to home, and 3-months post-discharge. ConclusionThis study will explore the efficacy of a digital ACT plus education intervention on parental stress levels. While position papers have advocated for the use of ACT with NICU parents, this study will be the first to test ACT as a stand-alone intervention with this population. Trial registrationThis trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 14 June 2023 (ACTRN12623000641695p).

Changes in health-related quality of life and sleep habits after a 6-month non-randomised cluster-controlled trial among children with overweight or obesity

Being overweight or obese can have severe negative psychological impacts and reduce health-related functioning. To improve health-related quality of life (HRQoL) and sleep habits for children with overweight or obesity, it is important to design and implement effective interventions. The aim of this study was to evaluate the effects of a 6-month family-based lifestyle intervention on HRQoL and sleep habits in Norwegian children with overweight or obesity in a primary-care setting. This 6-month, non-randomised, cluster-controlled trial included Norwegian children aged 5–13 years with overweight or obesity and their parents. A questionnaire was filled out by the parents. A total of 33 and 52 children in the control group and 41 and 78 children in the intervention group answered the HRQoL and sleep habits questions, respectively, and were included. The intervention group received individual family counselling and participated in physical activity groups and nutrition courses. The Children’s Sleep Habits Questionnaire (CSHQ) and Kidscreen-10 index were used to assess sleep habits and HRQoL. At baseline, the mean average scores for HRQoL were 50.0 [standard deviation (SD) 8.1] for the intervention group and 49.0 (SD 10.1) for the control group. For sleep habits at baseline, the mean average scores were 45.2 (SD 11.8) for the intervention group and 46.0 (SD 11.9) for the control group. No significant changes in HRQoL and sleep habits after the intervention were revealed. Overall, the family-based lifestyle intervention targeting overweight and obese children in a primary-care setting showed no significant effect on HRQoL or sleep quality.

Evaluating Chlamydia trachomatis and Neisseria gonorrhoeae screening and treatment among asymptomatic pregnant women to prevent preterm birth and low birthweight in Gaborone, Botswana: A secondary analysis from a non-randomised, cluster-controlled trial.

To evaluate the impact of screening and treating asymptomatic pregnant women for Chlamydia (C.) trachomatis and Neisseria (N.) gonorrhoeae infections on the frequency of preterm birth or low birthweight infants in Botswana. Non-randomised, cluster-controlled trial. Four antenatal care clinics in Gaborone, Botswana. Pregnant women aged ≥15 years, attending a first antenatal care visit, ≤27 weeks of gestation and without urogenital symptoms were eligible. Participants in the intervention clinics received screening (GeneXpert®, Cepheid) during pregnancy and at the postnatal visit. Participants in the standard-of-care clinics received screening at the postnatal visit only. We used multivariable logistic regression and post-estimation predictive margins analysis. Post-hoc analysis was conducted among sub-samples stratified by parity. Preterm birth (<37 weeks of gestation) and low birthweight (<2500 g). After controlling for parity, hypertension, antenatal care visits and clinic site, the predicted prevalence of preterm birth or low birthweight was lower in the intervention arm (11%) compared with the standard-of-care arm (16%) (adjusted odds ratio [aOR] 0.59; 95% confidence interval [CI] 0.28-1.24). In post-hoc analysis, the intervention was more effective than the standard-of-care (aOR 0.20; 95% CI 0.07-0.64) among nulliparous participants. A C. trachomatis and N. gonorrhoeae infection screening and treatment intervention among asymptomatic pregnant women may have reduced preterm birth or low birthweight outcomes, but results were not statistically significant. Post-hoc analysis found that the intervention reduced adverse outcomes among nulliparous participants.

Financial Incentives for COVID-19 Vaccines Help

Cash incentives for COVID-19 vaccination involve offering individuals a financial reward as an encouragement to get vaccinated against the coronavirus. This strategy has been implemented by various governments, organizations, and businesses as part of their efforts to increase vaccination rates. Duch and colleagues randomly assigned about 700 residents of several villages in Ghana to four groups in a cluster-controlled trial. The results show that participants assigned to the cash incentive treatments had an average rate of 81% (1,733 of 2,168) compared to 71% (1,895 of 2,669) for those in the placebo treatment arm. For self-reported vaccinations, the average rate for participants in the cash treatment was 3.5% higher than for participants in the placebo treatment (95% confidence interval (CI): 0.001, 6.9; P = 0.045): 40% (602 of 1,486) versus 36.3% (672 of 1,850). These results suggest that cash incentives help in vaccination uptake but paradoxically, low cash incentives resulted in higher vaccine uptake compared to high cash incentives. We found that cash incentives motivate individuals who may be hesitant or reluctant to receive the COVID-19 vaccine. Financial rewards can serve as an additional motivator for those who may be on the fence about getting vaccinated. Trial identifier: AEARCTR-0008775. Nat Med. 2023 Nov 27. doi: 10.1038/s41591-023-02670-4.

ICU Utilization After Implementation of Minor Severe Pneumonia Criteria in Real-Time Electronic Clinical Decision Support.

To determine if the implementation of automated clinical decision support (CDS) with embedded minor severe community-acquired pneumonia (sCAP) criteria was associated with improved ICU utilization among emergency department (ED) patients with pneumonia who did not require vasopressors or positive pressure ventilation at admission. Planned secondary analysis of a stepped-wedge, cluster-controlled CDS implementation trial. Sixteen hospitals in six geographic clusters from Intermountain Health; a large, integrated, nonprofit health system in Utah and Idaho. Adults admitted to the hospital from the ED with pneumonia identified by: 1) discharge International Classification of Diseases , 10th Revision codes for pneumonia or sepsis/respiratory failure and 2) ED chest imaging consistent with pneumonia, who did not require vasopressors or positive pressure ventilation at admission. After implementation, patients were exposed to automated, open-loop, comprehensive CDS that aided disposition decision (ward vs. ICU), based on objective severity scores (sCAP). The analysis included 2747 patients, 1814 before and 933 after implementation. The median age was 71, median Elixhauser index was 17, 48% were female, and 95% were Caucasian. A mixed-effects regression model with cluster as the random effect estimated that implementation of CDS utilizing sCAP increased 30-day ICU-free days by 1.04 days (95% CI, 0.48-1.59; p < 0.001). Among secondary outcomes, the odds of being admitted to the ward, transferring to the ICU within 72 hours, and receiving a critical therapy decreased by 57% (odds ratio [OR], 0.43; 95% CI, 0.26-0.68; p < 0.001) post-implementation; mortality within 72 hours of admission was unchanged (OR, 1.08; 95% CI, 0.56-2.01; p = 0.82) while 30-day all-cause mortality was lower post-implementation (OR, 0.71; 95% CI, 0.52-0.96; p = 0.03). Implementation of electronic CDS using minor sCAP criteria to guide disposition of patients with pneumonia from the ED was associated with safe reduction in ICU utilization.

Impacts of evidence-based nursing combined with enteral nutrition on nutritional status and quality of life in acute cerebral infarction patients: A randomized controlled trial.

To explore the impacts of evidence-based nursing (EBN) combined with enteral nutrition (EN) on nutritional status as well as quality of life in acute cerebral infarction (ACI) patients. In this randomized controlled cluster trial, 80 ACI patients admitted to our hospital from January 2021 to December 2022 were selected and randomly separated into study group (SG) and control group (CG), with 40 patients in each group. Patients in CG received routine nursing, and patients in the SG received EBN combined with EN. The neurological function, limb movement ability, nutritional status, anxiety and depression, incidence of complications and quality of life between two groups were compared. After intervention, the NIHSS score in the SG was lower than that in the CG (CG = 5.62 ± 0.56, SG = 3.27 ± 0.33. p < .001). The FMA score in the SG was higher compared with the CG (CG = 52.58 ± 5.32, SG = 68.85 ± 6.87. p < .001). The Hb level, TP level and ALB level in the SG were higher relative to the CG (p < .001). The Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) scores in the SG were lower in comparison with the CG (SAS score: CG = 42.32 ± 4.25, SG = 36.28 ± 3.64; SDS score: CG = 48.27 ± 4.85, SG = 40.06 ± 4.05. p < .001). The incidence of complications in SG was lower than that in CG. Finally, we found that SF-36 scores in the SG in all dimensions were higher than those in the CG (Physiological function: CG = 70.23 ± 7.05, SG = 82.71 ± 8.26. Role function: CG = 66.28 ± 6.64, SG73.39 ± 7.36. Physical pain: CG = 70.67 ± 7.06, SG = 82.69 ± 8.29. General health: CG = 58.74 ± 5.86, SG66.62 ± 6.65. Mental health: CG = 53.68 ± 5.37, SG = 62.39 ± 6.31. Energy: CG = 60.75 ± 6.08, SG = 67.87 ± 6.78. Social function: CG = 76.25 ± 7.25, SG = 85.78 ± 8.59. Emotional function: CG = 61.23 ± 6.15, SG = 75.74 ± 7.56. p < .001). EBN combined with EN can improve the nutritional status and the quality of life in ACI patients compared with the traditional routine nursing, and is suggested as a valuable strategy for clinical management of ACI.

Changes in dietary habits and BMI z-score after a 6-month non-randomized cluster-controlled trial among 6-12 years old overweight and obese Norwegian children.

Effective prevention programs to address the high prevalence of childhood overweight and obesity and the concomitant health consequences have been warranted. To improve dietary habits and weight status among Norwegian children with overweight/obesity in the primary care setting. A 6-month non-randomized cluster-controlled intervention among 137 children, aged 6-12 years, with overweight/obesity and their parents. Intervention and control groups were recruited by public health nurses and followed-up by 12 Healthy Life Centers across Norway. The intervention group received individual family counseling and participated in nutrition courses and physical activity groups. A frequency questionnaire assessing sociodemographic characteristics and dietary habits was completed by the parents. Trained public health nurses measured height and weight using standardized methods to calculate body mass index (BMI) and BMI z-scores. The intervention resulted in an increased odds of consuming evening meals (OR: 3.42), a decreased availability of salty snacks (β = -0.17), a decreased intake of salty snacks (-0.18), an increased consumption of water (β = 0.20), and a decreased estimated total intake of energy (β = -0.17), carbohydrates (β = -0.17), mono- and disaccharides (β = -0.21), sucrose (β = -0.24), and saturated fatty acids (β = -0.17). The intervention directly predicted lower BMI z-score (β = -0.17), and post-treatment levels of energy (β = -0.65), saturated fat (β = 0.43), and total carbohydrates (β = 0.41) were directly linked to BMI z-score after intervention. Age and sex were indirectly associated with BMI after intervention through energy and saturated fat intake. The intervention had a beneficial impact on nutrient intake and weight status among children with overweight/obesity. These findings provide support for implementing complex intervention programs tailored to local primary care settings. Clinicaltrials.gov, NCT02290171. Registered 13. November 2014, https://clinicaltrials.gov/ct2/show/NCT02290171.

Evaluation of a school health promotion program using the holistic WHO approach

Abstract Background A school health promotion program guided by the WHO approach is implemented in approximately 40% of public secondary schools in Lower Austria. Program advisors support participating schools in developing a systematic plan for the promotion of health and wellbeing of all students and teachers. This study aimed to evaluate the effectiveness of the program and identify potential areas for program optimization. Methods We applied a non-randomized controlled cluster trial with pre- and post-measurements (T0: October 2021 and T1: June 2022). We invited students, teachers and school principals of 30 program schools (PS) and 29 non-program schools (NPS) to fill in an online-questionnaire. We analyzed data of 2706 students, 451 teachers and 47 principals. Results The study showed that PS had established more favorable structures for school health promotion (HP) than NPS (e.g., established HP-team, financial resources setting objectives). Although PS implemented more HP activities than NPS (8.5 versus 6.3 activities), they merely took place as one-time events. At student level, an advantage for the PS over time was shown with respect to two out of 19 endpoints (subjective health status [b = 0.19, p &amp;lt; 0.001] and uptake of additionally offered physical activity lessons [b = 0.09; p = 0.04]). In two out of 19 endpoints, an advantage was also shown for the NPS (opportunities for physical activity during lessons and breaks [b = 0.06; p = 0.001], opportunities for participation [b = 0.20; p = 0.001]). At teacher level, in five out of 25 endpoints, the teachers of PS reported more favorable results than NPS’ teachers. Conclusions A supportive structure for school health promotion may be helpful for implementing more health promoting activities in schools. However, these activities do not seem to be profound enough to have an impact on the students. Teachers would need more support in implementing HP activities. Key messages • Structures for implementing health promoting activities are in place. • However, the implemented activities did only show limited effect on students.

Health-Related Quality of Life and Sleep Habits of Children with Overweight or Obesity

Abstract Background Obesity is a major public health challenge affecting children of all ages worldwide. Being overweight or obese can have severe negative psychological impacts and a significant reduction in health-related functioning. To improve health-related quality of life (HRQoL) and sleep habits for children with overweight/obesity, it is important to design and implement effective interventions. Few studies have included parents as behavioral agents to improve sleep habits and quality of life in children and adolescents with overweight/obesity. Methods This 6-month, non-randomized, cluster-controlled trial included 166 Norwegian children aged 5-13 years with overweight/obesity and their parents. The intervention group received individual family counselling and participated in physical activity groups and nutrition courses. A frequency questionnaire was filled out by parents, and the sleep habits questionnaire (CSHQ) and Kidsscreen-10 index (proxy version) were used to assess HRQoL. Results The results indicate that, overall, the children had good HRQoL. The mean average scores for HRQoL were 50.0 (standard deviation (SD): 8.1) for the intervention group and 49.0 (SD: 10.1) for the control group, which are broadly in line with normative data. For sleep habits, the mean average score was 43.8 (SD: 11.6) for the intervention group and 45.1 (SD: 11.7) for the control group. No significant changes in HRQoL and sleep habits were reported as a result of the intervention. Conclusions The children with overweight/obesity reported overall good HRQol at baseline and somewhat worse for sleep habits than the general population. No increase in quality of life or sleep quality was found in the intervention group compared to the control group in children with overweight/obesity. Key messages • The HRQoL among the children with overweight/obesity was good, but there were clinically relevant challenges related to sleep. • No increase in HRQoL and sleep habits were found after the intervention.

Smoking cessation intervention in the community pharmacy: Cost-effectiveness of a non-randomized cluster-controlled trial at 12-months’ follow-up

BackgroundThis study evaluated the cost-effectiveness of an intervention based on a training course for community pharmacists and a smoking cessation service (CESAR©), using limited societal and the health provider perspectives. MethodsNon-randomized controlled trial of 12-months’ follow-up. Spanish community pharmacists who were previously trained with CESAR© formed the intervention group (n = 102), and control group delivered usual care (n = 80). CESAR Patients were smokers identified by the community pharmacists when they attended the pharmacy. Data were self-reported. Outcomes were smoking cessation and quality-of-life (EQ-5D-3L) and were collected at baseline, 6, and 12 months. Costs data included direct health costs, work loss, and intervention costs. Smoking cessation was analyzed through logistic regression models. Generalized linear models were carried out for quality-adjusted life year (QALY) and costs. Incremental cost-effectiveness ratio (ICER) and cost-utility ratio (ICUR) were calculated. ResultsIn total, 800 smoking patients were included in the intervention group and 278 in the control group. Of these, 487 and 151 patients completed the study, respectively. Costs were lower in the intervention group compared to the control group in both perspectives. At 12 months, 54.3% and 37.1% patients from the intervention and the control groups reported smoking cessation, respectively. The difference in probability of cessation in the intervention compared to the control group was 17.6% (CI:0.05; 0.25). The mean QALY was higher in the intervention group [0.03(CI: 0.01; 0.07)]. The ICER and the ICUR were dominant for the intervention group. ConclusionThis intervention for smoking cessation showed that the CESAR© intervention, that combined a training for community pharmacists with a smoking cessation service was efficient for smoking cessation and QALY at 12 months’ follow-up. Trial registrationNCT05461066, retrospectively registered (July 15, 2022).

Effects of a clinic-based reproductive empowerment intervention on proximal outcomes of contraceptive use, self-efficacy, attitudes, and awareness and use of survivor services: a cluster-controlled trial in Nairobi, Kenya

This study was undertaken to evaluate the effect of a reproductive empowerment contraceptive counselling intervention (ARCHES) adapted to private clinics in Nairobi, Kenya on proximal outcomes of contraceptive use and covert use, self-efficacy, awareness and use of intimate partner violence (IPV) survivor services, and attitudes justifying reproductive coercion (RC) and IPV. We conducted a cluster-controlled trial among female family planning patients (N = 659) in six private clinics non-randomly assigned to ARCHES or control in and around Nairobi, Kenya. Patients completed interviews immediately before (baseline) and after (exit) treatment and at three- and six-month follow-up. We use inverse probability by treatment weighting (IPTW) applied to difference-in-differences marginal structural models to estimate the treatment effect using a modified intent-to-treat approach. After IPTW, women receiving ARCHES contraceptive counselling, relative to controls, were more likely to receive a contraceptive method at exit (86% vs. 75%, p < 0.001) and had a significantly greater relative increase in awareness of IPV services at from baseline to three- (beta 0.84, 95% CI 0.13, 1.55) and six-month follow-up (beta 0.92, 95% CI 0, 1.84) and a relative decrease in attitudes justifying RC from baseline to six-month follow-up (beta −0.34, 95% CI −0.65, −0.04). In the first evaluation of a clinic-based approach to address both RC and IPV in a low- or middle-income country (LMIC) context, we found evidence that ARCHES contraceptive counselling improved proximal outcomes related to contraceptive use and coping with RC and IPV. We recommend further study and refinement of this approach in Kenya and other LMICs. Plain Language Summary Reproductive coercion (RC) and intimate partner violence (IPV) are two forms of gender-based violence that are known to harm women’s reproductive health. While one intervention, ARCHES – Addressing Reproductive Coercion in Health Settings, has shown promise to improve contraceptive use and help women cope with RC and IPV in the United States, no approach has been proven effective in a low- or middle-income country (LMIC) context. In the first evaluation of a reproductive empowerment contraceptive counselling intervention in an LMIC setting, we found that ARCHES contraceptive counselling, relative to standard contraceptive counselling, improved proximal outcomes on contraceptive uptake, covert contraceptive use, awareness of local violence survives, and reduced attitudes justifying RC among women seeking contraceptive services in Nairobi, Kenya. Distal outcomes will be reported separately. Findings from this study support the promise of addressing RC and IPV within routine contraceptive counselling in Kenya on women’s proximal outcomes related to contraceptive use and coping with violence and coercion and should be used to inform the further study of this approach in Kenya and other LMICs.

Prevalence of Chlamydia trachomatis and Neisseria gonorrhoeae infection and associated factors among asymptomatic pregnant women in Botswana.

Chlamydia trachomatis (C. trachomatis) and Neisseria gonorrhoeae (N. gonorrhoeae) are curable sexually transmitted infections (STIs) that cause adverse pregnancy and neonatal outcomes. Most countries, including Botswana, do not offer C. trachomatis or N. gonorrhoeae screening during antenatal care (ANC) and instead use a syndromic approach for management of STIs. The Maduo Study is a prospective, cluster-controlled trial in Botswana evaluating the impact of diagnostic screening for antenatal C. trachomatis and N. gonorrhoeae infections to prevent adverse neonatal outcomes. Using baseline data from the Maduo Study (March 2021-March 2022), we determined the prevalence of C. trachomatis and N. gonorrhoeae infection among asymptomatic pregnant women in Botswana and correlates of infection using multivariable logistic regression. Of 251 women who underwent C. trachomatis and N. gonorrhoeae screening at first ANC visit, 55 (21.9%, 95%CI 17.0-27.5) tested positive for C. trachomatis, 1 (0.4%, 95%CI 0-2.2) for N. gonorrhoeae; and 2 (0.8%, 95%CI 0-2.8) for dual C. trachomatis and N. gonorrhoeae infection. Older age was associated with lower odds (aOR 0.93; 95%CI 0.88-0.98; p = 0.011) while any alcohol use during pregnancy was associated with higher odds (aOR = 3.53; 95%CI 1.22-10.16; p = 0.020) of testing positive for C. trachomatis or N. gonorrhoeae. A high frequency of C. trachomatis infections was detected among asymptomatic pregnant women in Botswana indicating that many antenatal STIs are missed by the syndromic management approach. Our results highlight the need for diagnostic C. trachomatis screening during ANC in Botswana and other low- and middle-income countries that rely solely on the syndromic approach for management of STIs.

Effects of a feedback intervention on antibiotic prescription control in primary care institutions based on a Health Information System: a cluster randomized cross-over controlled trial

Overuse and misuse of antibiotics are major factors in the development of antibiotic resistance in primary care institutions of rural China. In this study, the effectiveness of a Health Information System-based, automatic, and confidential antibiotic feedback intervention was evaluated. A randomized, cross-over, cluster-controlled trial was conducted in primary care institutions. All institutions were randomly divided into two groups and given either a three-month intervention followed by a three-month period without any intervention or vice versa. The intervention consisted of three feedback measures: a real-time pop-up warning message of inappropriate antibiotic prescriptions on the prescribing physician's computer screen, a 10-day antibiotic prescription summary, and distribution of educational manuals. The primary outcome was the 10-day inappropriate antibiotic prescription rate. There were no significant differences in inappropriate antibiotic prescription rates (69.1% vs. 72.0%) between two groups at baseline (P=0.072). After three months (cross-over point), inappropriate antibiotic prescription rates decreased significantly faster in group A (12.3%, P < 0.001) compared to group B (4.4%, P < 0.001). At the end point, the inappropriate antibiotic prescription rates decreased in group B (15.1%, P < 0.001) while the rates increased in group A (7.2%, P < 0.001). The characteristics of physicians did not significantly affect the rate of antibiotic or inappropriate antibiotic prescription rates. A Health Information System-based, real-time pop-up warnings, a 10-day prescription summary, and the distribution of educational manuals, can effectively reduce the rates of antibiotic and inappropriate antibiotic prescriptions.