Cluster-randomized Controlled Study Research Articles

The Effect of Health Education by Pharmacists on 10-Year Atherosclerotic Cardiovascular Disease Risk: A Cluster-Randomized Control Study in a Low Socioeconomic Status Javanese Population.

Background: Evidence from previous studies demonstrates that lifestyle modification reduces the incidence and complications of atherosclerotic cardiovascular disease. The study aimed to investigate the effect of a lifestyle intervention provided by pharmacists on the 10-year atherosclerotic cardiovascular disease (ASCVD) risk and quality of life (QoL) in a low socioeconomic status Javanese population. Methods: This research was a cluster-randomized controlled study of 1-year duration, conducted in a lower social economic community in the Sleman District of Yogyakarta, Indonesia. The eligible subjects were dichotomized into 2 groups: 40 to 55 years (n = 61 vs 65) and 56 to 70 years (n = 21 vs 43) for intervention and control subjects, respectively. The ASCVD score and risk factors within the age-based groups were analyzed using T test/Mann-Whitney test for continuous data or chi-square test for categorical data. Results: The intervention and control subjects had similar baseline characteristics (P > .05), including the ASCVD risk with the low- and high-risk classification for younger and elder subjects, respectively. At final follow-up, the younger intervention subjects had lower 10-year ASCVD risk (P = .001), higher high-density lipoprotein cholesterol (P = .02), smoking status (P = .001), persistence rate (P = .03), and QoL value for the physical and social function domains (P < .05) than the control subjects, whereas the elder intervention subjects only had better ASCVD risk score than controls (P = .03). Smoking interacting with intervention was the most influential variable on ASCVD risk in logistic regression analysis. Conclusion: The study demonstrates that the health education by the pharmacists produce significant outcomes of the ASCVD risk, smoking status, and QoL of physical and social function particularly in the younger group.

Correction: A cluster-randomized controlled study to evaluate a team coaching concept for improving teamwork and patient-centeredness in rehabilitation teams.

[This corrects the article DOI: 10.1371/journal.pone.0180171.].

Socio-Ecological Intervention to Promote Active Commuting to Work: Protocol and Baseline Findings of a Cluster Randomized Controlled Trial in Finland

Active commuting to work (ACW) is beneficial to traffic, environment and population health. More evidence is needed on effective ways to promote ACW. This paper describes the protocol and baseline findings of a cluster-randomized controlled study, which aims to promote ACW with multilevel strategies in two large workplace areas in Tampere, Finland. In Phase 1, the impacts of environmental strategies (trail improvements) were evaluated in 11 workplaces within Area 1. In Phase 2, five more workplaces were recruited from Area 2 to evaluate the impacts of social and behavioral strategies customized for each workplace. For this purpose, the workplaces in both areas were randomly assigned into experimental group (EXP, n = 6 + 2), which promoted ACW with social and behavioral strategies or into comparison group (COM, n = 5 + 3), which participated in the data collection only. The primary indicator in both phases is the change in employees’ ACW. Secondary indicators are e.g., changes in employees’ self-rated health, wellbeing at work, restrictions to and motivation for ACW, adverse effects due to ACW and the use and quality of the main walking and cycling trails. Also process, efficiency and environmental evaluation is included. The study is the first one in Finland to combine interdisciplinary collaboration between practitioners and researchers working in the fields of transportation, urban design, physical activity and sustainable development to promote ACW. The findings benefit all stakeholders interested in promoting ACW in urban context.

Drug-related problems in community-dwelling primary care patients screened positive for dementia.

Older people have a higher risk of drug-related problems (DRPs). However, little is known about the prevalence of DRPs in community-dwelling people who screened positive for dementia. Our study aimed to determine (1) the prevalence and types of DRPs and (2) the socio-demographic and clinical variables associated with DRPs in people screened positive for dementia in primary care. The Dementia: life- and person-centered help in Mecklenburg-Western Pomerania (DelpHi-MV) study is a general practitioner (GP)-based cluster-randomized controlled intervention study to implement and evaluate an innovative concept of collaborative dementia care management in the primary care setting in Germany. Medication reviews of 446 study participants were conducted by pharmacists based on a comprehensive baseline assessment that included a computer-based home medication assessment. ClinicalTrials.gov Identifier: NCT01401582. A total of 1,077 DRPs were documented. In 414 study participants (93%), at least one DRP was detected by a pharmacist. The most frequent DRPs were administration and compliance problems (60%), drug interactions (17%), and problems with inappropriate drug choice (15%). The number of DRPs was significantly associated with the total number of drugs taken and with a formal diagnosis of a mental or behavioral disorder. Degree of cognitive impairment (MMSE defined) and formal diagnosis of dementia were not risk factors for an increased number of DRPs. However, the total number of drug taken and the presence of a diagnosis of mental and behavioral disorders were associated with an increased total number of DRPs.

A cluster-randomized controlled study to evaluate a team coaching concept for improving teamwork and patient-centeredness in rehabilitation teams.

PurposeAlthough the relevance of interprofessional teamwork in the delivery of patient-centered care is well known, there is a lack of interventions for improving team interaction in the context of rehabilitation in Germany. The aim of the present study is to evaluate whether a specially developed team coaching concept (TCC) could improve both teamwork and patient-centeredness.MethodA multicenter, cluster-randomized controlled intervention study was conducted with both staff and patient questionnaires. Data was collected at ten German rehabilitation clinics (five clusters) of different indication fields before (t1) and after (t2) the intervention. Intervention clinics received the TCC, while control clinics did not receive any treatment. Staff questionnaires were used to measure internal participation and other aspects of teamwork, such as team organization, while patient questionnaires assessed patient-centeredness. A multivariate analysis of variance was applied for data analysis.ResultsIn order to analyze the effect of TCC on internal participation and teamwork, 305 questionnaires were included for t1 and 213 for t2 in the staff survey. In the patient survey, 523 questionnaires were included for t1 and 545 for t2. The TCC improved team organization, willingness to accept responsibility and knowledge integration according to staff, with small effect sizes (univariate: η2=.010–.017), whereas other parameters including internal participation, team leadership and cohesion did not improve due to the intervention. The patient survey did not show any improvements on the assessed dimensions.ConclusionThe TCC improved dimensions that were addressed directly by the approach and were linked to the clinics’ needs, such as restructured team meetings and better exchange of information. The TCC can be used to improve team organization, willingness to accept responsibility, and knowledge integration in rehabilitation practice, but some further evaluation is needed to understand contextual factors and processes regarding the implementation of the intervention.

Effectiveness of a standardized patient education program on therapy-related side effects and unplanned therapy interruptions in oral cancer therapy: a cluster-randomized controlled trial.

Oral agents for cancer treatment are increasingly prescribed due to their benefits. However, oral cancer medications are difficult to handle and have a considerable potential for side effects. This type of therapy requires a high level of self-management competence by the patient. A standardized patient education program provided by physicians and oncology nurses may positively influence the handling of oral agents. The aim of the study was to evaluate the impact of a standardized patient education program provided by specially trained oncology nurses on therapy management regarding side effects and unplanned therapy interruptions. One hundred sixty-five patients from 28 office-based oncology practices from all over Germany participated in this cluster-randomized controlled study. Patients of both intervention (n=111) and standard care groups (n=54) received the usual oncologist counseling; in addition, the patients from the intervention group (k=17 practices) received an education from specially trained oncology nurses. The time of observation was 3months per patient. The patients of the intervention group reported fewer side effects (skin rash, pain, fatigue, nausea, vomiting). Patients in the standard care group interrupted the therapy more frequently without informing their oncologist, compared to the intervention group. Patients benefit from a standardized patient education program provided by specially trained oncology nurses. They tend to handle side effects and critical situations better.

Impact of tapered-cuff tracheal tube on microaspiration of gastric contents in intubated critically ill patients: a multicenter cluster-randomized cross-over controlled trial.

Studies on the impact of tapered-cuff tracheal tubes on rates of microaspiration and ventilator-associated pneumonia (VAP) in intubated patients have reported conflicting results. The aim of this study was to determine the influence of this shape of tracheal cuff on abundant microaspiration of gastric contents in critically ill patients. All patients intubated in the intensive care unit (ICU) and requiring mechanical ventilation for at least 48h were eligible for this multicenter cluster-randomized controlled cross-over open-label study. The primary outcome was abundant microaspiration of gastric contents, defined by the presence of pepsin at significant level in>30% of tracheal aspirates. Quantitative measurement of pepsin and salivary amylase was performed in all tracheal aspirates during the 48h following enrollment. A total of 326 patients were enrolled in the ten participating ICUs (162 in the PVC tapered-cuff group and 164 in the standard-cuff group). Patient characteristics were similar in the two study groups. The proportion of patients with abundant microaspiration of gastric contents was 53.5% in the tapered-cuff and 51.0% in the standard-cuff group (odds ratio 1.14, 95% CI 0.72-1.82). While abundant microaspiration of oropharyngeal secretions was not significantly different (77.4 vs 68.6%, p=0.095), the proportion of patients with tracheobronchial colonization was significantly lower (29.6 vs 43.3%, p=0.01) in the tapered-cuff than in the standard-cuff group. No significant difference between the two groups was found for other secondary outcomes, including ventilator-associated events and VAP. This trial showed no significant impact of tapered-cuff tracheal tubes on abundant microaspiration of gastric contents. ClinicalTrials.gov, number NCT01948635.

Performance of Health Workers Using an Electronic Algorithm for the Management of Childhood Illness in Tanzania: A Pilot Implementation Study.

In low-resource settings, where qualified health workers (HWs) are scarce and childhood mortality high, rational antimicrobial prescription for childhood illnesses is a challenge. To assess whether smartphones running guidelines, as compared with paper support, improve consultation process and rational use of medicines for children, a pilot cluster-randomized controlled study was conducted in Tanzania. Nine primary health-care facilities (HFs) were randomized into three arms: 1) paper algorithm, 2) electronic algorithm on a smartphone, and 3) control. All HWs attending children aged 2-59 months for acute illness in intervention HFs were trained on a new clinical algorithm for management of childhood illness (ALMANACH) either on 1) paper or 2) electronic support; 4 months after training, consultations were observed. An expert consultation was the reference for classification and treatment. Main outcomes were proportion of children checked for danger signs, and antibiotics prescription rate. A total of 504 consultations (166, 171, and 167 in control, paper, and phone arms, respectively) were observed. The use of smartphones versus paper was associated with a significant increase in children checked for danger signs (41% versus 74%, P = 0.04). Antibiotic prescriptions rate dropped from 70% in the control to 26%, and 25% in paper and electronic arms. The HWs-expert agreement on pneumonia classification remained low (expert's pneumonia identified by HWs in 26%, 30%, and 39% of patients, respectively).Mobile technology in low-income countries is implementable and has a potential to improve HWs' performance. Additional point-of-care diagnostic tests are needed to ensure appropriate management. Improving the rational use of antimicrobial is a challenge that ALMANACH can help to take up.

Dynamic Change of Aggressive Behavior and Victimization Among Adolescents: Effectiveness of the ViSC Program

The present study reports a high-quality evaluation of the ViSC Social Competence Program, which was implemented large scale in Austria. A rigorous test of program effectiveness has been performed to investigate the dynamic change of aggressive behavior and victimization and to ensure a high level of statistical conclusion validity. A cluster randomized control study was applied to examine program effectiveness regarding aggressive behavior and victimization. In sum, 1,377 adolescents (48.5% girls, Mage = 11.7) enrolled in 13 schools participated in the program; 665 adolescents (45.2% girls, Mage = 11.6) enrolled in 5 schools were in the control group. Data were collected with Internet-based questionnaires at pre- and posttest with several validated scales to capture the full range of the two constructs. To ensure construct validity, a series of invariance tests of the second-order factor models were performed. To test program effectiveness, a multiple group bivariate latent change score model was applied. Evidence for a dynamic change of aggressive behavior and victimization was found. As predicted, the pretest levels and the change scores of aggressive behavior and victimization were associated. Moreover, higher levels of pretest values predicted more change. The program was effective in reducing victimization but not aggressive behavior. Gender did not moderate the results. Results are important for national rollout and cross-national dissemination of the program. However, further research is needed to investigate the underlying mechanisms of the intervention effects.

Tubaramure, a Food-Assisted Integrated Health and Nutrition Program in Burundi, Increases Maternal and Child Hemoglobin Concentrations and Reduces Anemia: A Theory-Based Cluster-Randomized Controlled Intervention Trial

Background: Despite their popularity, food-assisted maternal and child health and nutrition (MCHN) programs have not been evaluated rigorously, and evidence of their impacts on maternal and child outcomes is scant.Objective: This study estimated the impact of Tubaramure, a food-assisted MCHN program implemented by Catholic Relief Services and partners in eastern Burundi, on hemoglobin and anemia (primary outcome) in children aged 0–23.9 mo and their mothers and explored the impact pathways. The program targeted women and their children during their first 1000 d of life and included 1) food rations, 2) strengthening and promotion of the use of health services, and 3) behavior change communication.Methods: This was a cluster-randomized controlled study to assess program impact by using cluster fixed-effects double-difference models with repeated cross-sectional data (baseline and follow-up 2 y later). We explored impact pathways by estimating impact on intermediary factors addressed by Tubaramure that are known determinants of hemoglobin and anemia and by regressing hemoglobin and anemia on each determinant to assess the plausibility that the effect operated through each determinant.Results: Hemoglobin decreased and anemia increased markedly from baseline to follow-up, but Tubaramure had a significant (P < 0.05) beneficial effect on both children [6.1 percentage points (pps) and mothers who had given birth in the previous 3 mo (34.9 pps). The program also had significant (P < 0.05) impacts on factors along the hypothesized impact pathways: dietary diversity, consumption of iron-rich foods, morbidity, and fever for child hemoglobin and dietary diversity, consumption of iron-rich foods, and current bed-net use for maternal anemia.Conclusions: We showed, for the first time to our knowledge, that a food-assisted MCHN program had a positive impact on anemia and hemoglobin in both mothers and children. The plausible pathways identified highlight the importance of addressing multiple determinants of anemia. This trial was registered at clinicaltrials.gov as NCT01072279.

Priority Setting and Influential Factors on Acceptance of Pharmaceutical Recommendations in Collaborative Medication Reviews in an Ambulatory Care Setting - Analysis of a Cluster Randomized Controlled Trial (WestGem-Study).

BackgroundMedication reviews are recognized services to increase quality of therapy and reduce medication risks. The selection of eligible patients with potential to receive a major benefit is based on assumptions rather than on factual data. Acceptance of interprofessional collaboration is crucial to increase the quality of medication therapy.ObjectiveThe research question was to identify and prioritize eligible patients for a medication review and to provide evidence-based criteria for patient selection. Acceptance of the prescribing general practitioner to implement pharmaceutical recommendations was measured and factors influencing physicians’ acceptance were explored to obtain an impression on the extent of collaboration in medication review in an ambulatory care setting.MethodsBased on data of a cluster-randomized controlled study (WestGem-study), the correlation between patient parameters and the individual performance in a medication review was calculated in a multiple logistic regression model. Physician’s acceptance of the suggested intervention was assessed using feedback forms. Influential factors were analyzed.ResultsThe number of drugs in use (p = 0.001), discrepancies between prescribed and used medicines (p = 0.014), the baseline Medication Appropriateness Index score (p<0.001) and the duration of the intervention (p = 0.006) could be identified as influential factors for a major benefit from a medication review, whereas morbidity (p>0.05) and a low kidney function (p>0.05) do not predetermine the outcome. Longitudinal patient care with repeated reviews showed higher interprofessional acceptance and superior patient benefit. A total of 54.9% of the recommendations in a medication review on drug therapy were accepted for implementation.ConclusionsThe number of drugs in use and medication reconciliation could be a first rational step in patient selection for a medication review. Most elderly, multimorbid patients with polymedication experience a similar chance of receiving a benefit from a medication review. Longitudinal patient care should be preferred over confined medication reviews. The acceptance of medication reviews by physicians supports further implementation into health care systems.Trial RegistrationISRCTN ISRCTN41595373

Fuel for Fun: a cluster-randomized controlled study of cooking skills, eating behaviors, and physical activity of 4th graders and their families.

BackgroundChildhood obesity remains a serious concern in the United States and in many other countries. Direct experience preparing and tasting healthful foods and increasing activity during the school day are promising prevention approaches. Engaging parents and families remains an important challenge. Fuel for Fun: Cooking with Kids Plus Parents and Play is a multi-component school- and family-based intervention for 4th graders and their families intended to promote positive food and activity environments, policies and behaviors at the individual, family and school levels. This paper describes the design and evaluation plan.Methods/DesignFour cohorts of 4th-graders and their parents from 8 schools in 2 districts in the same Northern Colorado region are participating in a 4-arm cluster randomized controlled trial. Theory-based Fuel for Fun consists of 5 components delivered over 1 school year: 1) Cooking with Kids - Colorado; an experiential classroom-based cooking and tasting curriculum, 2) Cafeteria Connections; cafeteria-based reinforcements of classroom food experiences using behavioral economic strategies, 3) SPARK active recess; a playground intervention to engage children in moderate to vigorous activity, 4) Fuel for Fun Family; multi-element supports targeting parents to reinforce the 3 school-based components at home, and 5) About Eating; an online interactive program for parents addressing constructs of eating competence and food resource management. Outcomes include child and parent measures of fruit and vegetable preferences and intake, cooking, physical activity, sedentary behaviors and attitudes. School level data assess lunch plate waste and physical activity at recess. In-depth diet and accelerometry assessments are collected with a subsample of parent-child dyads. Data are collected at baseline, immediately post-intervention at 7 months, and at 12 month follow-up. We anticipate recruiting 1320–1584 children and their parents over the length of the project.DiscussionThe Fuel for Fun study design allows for impact assessment of school-, family- and online parent-based intervention components separately and in combination. Study strengths include use of theory- and evidence-based programs, valid child and parent self-report instruments, and objective measures of food, cooking, and physical activity behaviors at the individual, family and school levels. Parent involvement and engagement is examined through multiple strategies.Trial registrationClinicaltrials.gov registration number NCT02491294. Registered 7 July, 2015.

‘FIFA 11 for Health’ for Europe. II: effect on health markers and physical fitness in Danish schoolchildren aged 10–12 years

ObjectivesTo evaluate whether a modified ‘FIFA 11 for Health’ programme for non-communicable diseases had effects on body composition, blood pressure and physical fitness of Danish schoolchildren aged 10–12 years.DesignA cluster-randomised...

Low socio‐economic status associated with unhealthy weight in six‐year‐old Swedish children despite higher levels of physical activity

Socio-economic status is an important determinant of physical activity, sedentary behaviour and body mass index, but these associations are contradictory in younger children. We investigated the associations between parental socio-economic status, physical activity, sedentary behaviour and body mass index in six-year-old children, to identify possible differences in physical activity between socio-economic groups. The study comprised 621 children from Stockholm suburbs, recruited from, A healthy school start, a cluster-randomised controlled intervention study. A cross-sectional study was performed using baseline data. Physical activity and sedentary behaviour were assessed by accelerometry, body weight and height were measured, and body mass index was calculated. Sedentary behaviour was also assessed using a questionnaire. We found that 12% of the study population were overweight and 9% were obese. Children from families with low socio-economic status were more physically active and slightly less sedentary, but were almost twice as likely to be overweight or obese than children from high socio-economic status, irrespective of the child's sex. Low socio-economic status was associated with higher physical activity, lower sedentary behaviour and an unhealthier weight status compared to high socio-economic status, suggesting a role of diet as a cause of the higher overweight and obesity prevalence.

Team Development in Medical Rehabilitation: Concept and Evaluation of a Team Intervention

Interprofessional collaboration is a main precondition of successful treatment in rehabilitation. In order to improve interprofessional collaboration, a clinic-specific, goal- and solution-oriented and systemic team development approach was designed. The aim of the study is the evaluation of this approach. A multi-centre cluster-randomized controlled study with staff questionnaires. The team development could be implemented successfully in 4 of 5 clinics and led to significant improvements in team organisation, willingness to accept responsibility and knowledge integration. The effects are small and are caused by the opposed development of intervention and control group. The team development approach can be recommended for rehabilitation practice. A train-the-trainer approach will be developed and further studies are planned in order to disseminate the approach and to investigate the conditions of implementation.

Reduction of self-perceived discomforts in critically ill patients in French intensive care units: study protocol for a cluster-randomized controlled trial.

BackgroundIt is now well documented that critically ill patients are exposed to stressful conditions and experience discomforts from multiple sources. Improved identification of the discomforts of patients in intensive care units (ICUs) may have implications for managing their care, including consideration of ethical issues, and may assist clinicians in choosing the most appropriate interventions. The primary objective of this study was to assess the effectiveness of a multicomponent program of discomfort reduction in critically ill patients. The secondary objectives were to assess the sustainability of the impact of the program and the potential seasonality effect.Methods/designWe conducted a multicenter, cluster-randomized, controlled, single (patient)-blind study involving 34 French adult ICUs. The experimental intervention was a 6-month period during which the multicomponent program was implemented in the ICU and included the following steps: identification of discomforts, immediate feedback to the healthcare team, and implementation of targeted interventions. The control intervention was a 6-month period during which any program was implemented. The primary endpoint was the monthly overall score of self-reported discomfort from the French questionnaire on discomforts in ICU patients (IPREA). The secondary endpoints were the scores of the discomfort items of IPREA. The sample size was 660 individuals to obtain 80 % power to detect a 25 % difference in the overall discomfort score of IPREA between the two groups (design effect: 2.9).DiscussionThe results of this cluster-randomized controlled study are expected to confirm that a multicomponent program of discomfort reduction may be a new strategy in the management of care for critically ill patients.Trial registrationClinicalTrials.gov NCT02442934 , registered 11 May 2015.

Cluster-Randomized Controlled Study of SMS Text Messages for Prevention of Mother-to-Child Transmission of HIV in Rural Kenya.

Background. Antiretroviral medications are key for prevention of mother-to-child transmission (PMTCT) of HIV, and transmission mitigation is affected by service delivery, adherence, and retention. Methods. We conducted a cluster-randomized controlled study in 26 facilities in Nyanza, Kenya, to determine the efficacy of SMS text messages on PMTCT outcomes. The relative risk and confidence intervals were estimated at the facility level using STATA. Results. 550 women were enrolled, from June 2012 to July 2013. The median age was 25.6 years, and 85.3% received ARVs. Maternal ARV use was similar between the intervention and control arms: 254/261 (97.3%) versus 241/242 (99.6%) at 34–36 weeks of gestation and 234/247 (94.7%) versus 229/229 (100%) at delivery. Among infants, 199/246 (80.9%) and 209/232 (90.1%) received ARVs (RR: 0.91; 95% CI: 0.77–1.14); 88% versus 88.6% were tested for HIV at 6 weeks, with 1/243 (0.4%) and 3/217 (1.4%) positive results in the intervention and control arms, respectively. Communication increased in both the intervention and control arms, with the mean number of 7.5 (SD: 5.70) compared with 6 (SD: 9.96), p < 0.0001. Conclusions. We identified high ARV uptake and infant HIV testing, with very low HIV transmission. Increased communication may influence health-seeking behaviors irrespective of technology. The long-term effectiveness of facilitated communication on PMTCT outcomes needs to be tested. The study has been registered on ClinicalTrials.gov under the identifier NCT01645865.

A Cluster-Randomized Controlled Intervention Study to Assess the Effect of a Contact Intervention in Reducing Leprosy-Related Stigma in Indonesia.

BackgroundCan deliberate interaction between the public and persons affected by leprosy reduce stigmatization? The study described in this paper hypothesises that it can and assesses the effectiveness of a ‘contact intervention’.Methods/Principal FindingsThis cluster-randomized controlled intervention study is part of the Stigma Assessment and Reduction of Impact (SARI) project conducted in Cirebon District, Indonesia. Testimonies, participatory videos and comics given or made by people affected by leprosy were used as methods to facilitate a dialogue during so-called ‘contact events’. A mix of seven quantitative and qualitative methods, including two scales to assess aspects of stigma named the SDS and EMIC-CSS, were used to establish a baseline regarding stigma and knowledge of leprosy, monitor the implementation and assess the impact of the contact events. The study sample were community members selected using different sampling methods. The baseline shows a lack of knowledge about leprosy, a high level of stigma and contrasting examples of support. In total, 91 contact events were organised in 62 villages, directly reaching 4,443 community members (mean 49 per event). The interview data showed that knowledge about leprosy increased and that negative attitudes reduced. The adjusted mean total score of the EMIC-CSS reduced by 4.95 points among respondents who had attended a contact event (n = 58; p <0.001, effect size = 0.75) compared to the score at baseline (n = 213); for the SDS this was 3.56 (p <0.001, effect size = 0.81). About 75% of those attending a contact event said they shared the information with others (median 10 persons).Conclusions/SignificanceThe contact intervention was effective in increasing knowledge and improving public attitudes regarding leprosy. It is relatively easy to replicate elsewhere and does not require expensive technology. More research is needed to improve scalability. The effectiveness of a contact intervention to reduce stigma against other neglected tropical diseases and conditions should be evaluated.

Lifestyle intervention for gestational diabetes mellitus prevention: A cluster-randomized controlled study

ObjectiveThe study was to examine whether gestational diabetes mellitus (GDM) can be prevented by early trimester lifestyle counseling in a high-risk population. MethodsFrom September 2012 to January 2013, 1664 pregnancies in the Department of Obstetrics and Gynecology of First Hospital of Peking University were enrolled in the study during their first prenatal care visit before the 8 gestational weeks visit and asked to fill out a questionnaire on GDM risk evaluation. According to the questionnaire and medical records, those with at least one risk factor of GDM were included in the intervention study and randomly allocated to two groups, intervention group and control group. Routine prenatal care was offered, while standardized two-step lifestyle intervention was provided to the intervention group during 6–8 gestational weeks, and at 12–13 gestational weeks, enforcement intervention based on maternal anthropometrics were offered. Both groups were followed until 75 g oral glucose tolerance test (OGTT) testing at 24–28 gestational weeks. The weight gain after intervention and the prevalence of GDM were used to evaluate the effect. Results(1) According to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria, the positive rate of GDM for the intervention group was 17.16% (23/134), lower than the control group which was 23.91% (33/138), P = 0.168. (2) The weight gain during the first and second trimester for the intervention group was (1.38 ± 2.34) kg and (5.51 ± 2.18) kg, lower than in the control group which was (1.41 ± 2.58) kg and (5.66 ± 2.25) kg, (P = 0.905, P = 0.567). (3) Positive rate of GDM for those fasting plasma glucose (FPG) ≥5.1 mmol/L during early pregnancy was 11/36 (30.55%) for the intervention group that was lower than 17/37 (45.95%) for the control group, but the statistical difference was not significant (P = 0.076). ConclusionThe positive rate of GDM could be reduced by a certain amount lifestyle intervention from the beginning of pregnancy. More validated effective intervention should be explored in the high-risk pregnant women.

Physical self-esteem and personality traits in Swedish physically inactive female high school students: an intervention study.

Physical activity provides fundamental health benefits and plays a positive role in physical well-being. The aim of this present study was to investigate whether a 6-month physical activity program could influence physical self-esteem and frequency of physical activity in physically inactive female high school students in short- and long-term periods and whether personality traits were related to physical activity behaviour and compliance with the program. The study was a cluster-randomised controlled intervention study including 104 physically inactive female high school students aged 16-19 years, 60 females in an intervention group and 44 females in a control group. The intervention group exercised at sport centres at least once per week during a 6-month period. Questionnaires were used for evaluation. At a 6-month follow up, the intervention group improved physical self-perception in all subdomains and significantly improved physical condition, physical self-worth and self-related health compared to the control group. At 1-year follow up, 25 females out of 53 females were still physically active, and all ratings remained almost the same as at the 6-month follow up. There were no particular personality traits that were dominant in the groups. A 6-month physical activity program can positively influence physical self-esteem and the frequency of physical activity, both from a short- and long-term perspective.