Effectiveness of routine third trimester ultrasonography to reduce adverse perinatal outcomes in low risk pregnancy (the IRIS study): nationwide, pragmatic, multicentre, stepped wedge cluster randomised trial.

OBJECTIVES: To investigate the effectiveness of routine ultrasonography in the third trimester in reducing adverse perinatal outcomes in low risk pregnancies compared with usual care and the effect of this policy on maternal outcomes and obstetric interventions. DESIGN: Pragmatic, multicentre, stepped wedge cluster randomised trial. SETTING: 60 midwifery practices in the Netherlands. PARTICIPANTS: 13 046 women aged 16 years or older with a low risk singleton pregnancy. INTERVENTIONS: 60 midwifery practices offered usual care (serial fundal height measurements with clinically indicated ultrasonography). After 3, 7, and 10 months, a third of the practices were randomised to the intervention strategy. As well as receiving usual care, women in the intervention strategy were offered two routine biometry scans at 28-30 and 34-36 weeks' gestation. The same multidisciplinary protocol for detecting and managing fetal growth restriction was used in both strategies. MAIN OUTCOME MEASURES: The primary outcome measure was a composite of severe adverse perinatal outcomes: perinatal death, Apgar score <4, impaired consciousness, asphyxia, seizures, assisted ventilation, septicaemia, meningitis, bronchopulmonary dysplasia, intraventricular haemorrhage, periventricular leucomalacia, or necrotising enterocolitis. Secondary outcomes were two composite measures of severe maternal morbidity, and spontaneous labour and birth. RESULTS: Between 1 February 2015 and 29 February 2016, 60 midwifery practices enrolled 13 520 women in mid-pregnancy (mean 22.8 (SD 2.4) weeks' gestation). 13 046 women (intervention n=7067, usual care n=5979) with data based on the national Dutch perinatal registry or hospital records were included in the analyses. Small for gestational age at birth was significantly more often detected in the intervention group than in the usual care group (179 of 556 (32%) v 78 of 407 (19%), P<0.001). The incidence of severe adverse perinatal outcomes was 1.7% (n=118) for the intervention strategy and 1.8% (n=106) for usual care. After adjustment for confounders, the difference between the groups was not significant (odds ratio 0.88, 95% confidence interval 0.70 to 1.20). The intervention strategy showed a higher incidence of induction of labour (1.16, 1.04 to 1.30) and a lower incidence of augmentation of labour (0.78, 0.71 to 0.85). Maternal outcomes and other obstetric interventions did not differ between the strategies. CONCLUSION: In low risk pregnancies, routine ultrasonography in the third trimester along with clinically indicated ultrasonography was associated with higher antenatal detection of small for gestational age fetuses but not with a reduced incidence of severe adverse perinatal outcomes compared with usual care alone. The findings do not support routine ultrasonography in the third trimester for low risk pregnancies. TRIAL REGISTRATION: Netherlands Trial Register NTR4367.

Effectiveness of a Worksite Intervention for Male Construction Workers on Dietary and Physical Activity Behaviors, Body Mass Index, and Health Outcomes: Results of a Randomized Controlled Trial.

PURPOSE: To evaluate the effectiveness of an individually tailored intervention for improvement in lifestyle behavior, health indicators, and prevention and reduction of overweight among construction workers. DESIGN: Randomized controlled trial. SETTING: Various blue-collar departments of a large construction company in the Netherlands. PARTICIPANTS: Blue-collar workers randomized to an intervention (n = 162) or a control group (n = 152). INTERVENTION: The intervention group received individual coaching sessions, tailored information, and materials to improve lifestyle behavior during a 6-month period, and the control group received usual care. MEASURES: Body weight, body mass index (BMI), waist circumference, physical activity (PA) levels, dietary behavior, blood pressure, and blood cholesterol were assessed. ANALYSIS: Effectiveness of the intervention on outcome measures at 6- and 12-month follow-up was assessed by using linear and logistic regression models adjusting for baseline levels. RESULTS: After 6 months, a statistically significant intervention effect was found on body weight ( B = -1.06, P = .010), BMI ( B = -0.32, P = .010), and waist circumference ( B = -1.38, P = .032). At 6 months, the percentage of those meeting public health guidelines for PA increased significantly in the intervention group compared to the control group ( B = 2.06, P = .032), and for sugar-sweetened beverages, an intervention effect was found at 6 months as well ( B = -2.82, P = .003). At 12 months, for weight-related outcomes, these differences were slightly smaller and no longer statistically significant. The intervention was not effective on the total amount of moderate to vigorous PA and other dietary and health outcomes. CONCLUSION: Intervention participants showed positive changes in vigorous PA and intake of sugar-sweetened beverages compared to controls, as well as effects on weight-related outcomes at 6 months. Long-term effects were still promising but not statistically significant.

Effectiveness and cost-effectiveness of routine third trimester ultrasound screening for intrauterine growth restriction: study protocol of a nationwide stepped wedge cluster-randomized trial in The Netherlands (The IRIS Study).

BACKGROUND: Intrauterine growth retardation (IUGR) is a major risk factor for perinatal mortality and morbidity. Thus, there is a compelling need to introduce sensitive measures to detect IUGR fetuses. Routine third trimester ultrasonography is increasingly used to detect IUGR. However, we lack evidence for its clinical effectiveness and cost-effectiveness and information on ethical considerations of additional third trimester ultrasonography. This nationwide stepped wedge cluster-randomized trial examines the (cost-)effectiveness of routine third trimester ultrasonography in reducing severe adverse perinatal outcome through subsequent protocolized management. METHODS: For this trial, 15,000 women with a singleton pregnancy receiving care in 60 participating primary care midwifery practices will be included at 22 weeks of gestation. In the intervention (n = 7,500) and control group (n = 7,500) fetal growth will be monitored by serial fundal height assessments. All practices will start offering the control condition (ultrasonography based on medical indication). Every three months, 20 practices will be randomized to the intervention condition, i.e. apart from ultrasonography if indicated, two routine ultrasound examinations will be performed (at 28-30 weeks and 34-36 weeks). If IUGR is suspected, both groups will receive subsequent clinical management as described in the IRIS study protocol that will be developed before the start of the trial. The primary dichotomous clinical composite outcome is 'severe adverse perinatal outcome' up to 7 days after birth, including: perinatal death; Apgar score <4 at 5 minutes after birth; impaired consciousness; need for assisted ventilation for more than 24 h; asphyxia; septicemia; meningitis; bronchopulmonary dysplasia; intraventricular hemorrhage; cystic periventricular leukomalacia; neonatal seizures or necrotizing enterocolitis. For the economic evaluation, costs will be measured from a societal perspective. Quality of life will be measured using the EQ-5D-5 L to enable calculation of QALYs. Cost-effectiveness and cost-utility analyses will be performed. In a qualitative sub-study (using diary notes from 32 women for 9 months, at least 10 individual interviews and 2 focus group studies) we will explore ethical considerations of additional ultrasonography and how to deal with them. DISCUSSION: The results of this trial will assist healthcare providers and policymakers in making an evidence-based decision about whether or not introducing routine third trimester ultrasonography. TRIAL REGISTRATION: NTR4367 , 21 March 2014.

The effect of a health promotion intervention for construction workers on work-related outcomes: results from a randomized controlled trial.

PURPOSE: The objective of the present study is to investigate the effects of a worksite health promotion intervention on musculoskeletal symptoms, physical functioning, work ability, work-related vitality, work performance, and sickness absence. METHODS: In a randomized controlled design, 314 construction workers were randomized into an intervention group (n = 162) receiving personal coaching, tailored information, and materials, and a control group (n = 152) receiving usual care. Sickness absence was recorded continuously in company records, and questionnaires were completed before, directly after the 6-month intervention period, and 12 months after baseline measurements. Linear and logistic regression analyses were performed to determine intervention effects. RESULTS: No significant changes at 6 or 12 months of follow-up were observed in musculoskeletal symptoms, physical functioning, work ability, work-related vitality, work performance, and sickness absence as a result of the intervention. CONCLUSIONS: This study shows that the intervention was not statistically significantly effective on secondary outcomes. Although the intervention improved physical activity, dietary, and weight-related outcomes, it was not successful in decreasing musculoskeletal symptoms and improving other work-related measures. Presumably, more multifaceted interventions are required to establish significant change in these outcomes.

Process evaluation of a multifaceted health program aiming to improve physical activity levels and dietary patterns among construction workers.

OBJECTIVE: To evaluate the process of a health promotion program, aiming to improve physical activity levels and diet among construction workers. METHODS: The process evaluation was conducted after the RE-AIM framework for the evaluation of the public health impact of health promotion interventions. Effectiveness was assessed on motivational stage-of-change, self-efficacy, and decisional balance for physical activity and dietary behavior. RESULTS: The external validity of the trial was satisfactory with representative reach of workers and adoption of workplace units in the participating construction company. The extent to which the program was implemented as intended was modest. The intervention was effective on participants' progress through stages of behavior change. CONCLUSIONS: Based on the RE-AIM dimensions, it is concluded that for construction workers, the program is feasible and potentially effective, but adjustments are required before widespread implementation.

The relation between body mass index and musculoskeletal symptoms in the working population.

BACKGROUND: The primary aim of this study was to investigate the association between BMI and musculoskeletal symptoms in interaction with physical workload. In addition, it was aimed to obtain insight into whether overweight and obesity are associated with an increase in occurrence of symptoms and/or decrease in recovery from symptoms. METHODS: Based on a large working population sample (n = 44,793), using the data from The Netherlands Working Conditions Survey (NWCS), logistic regression analyses were carried out to investigate the association between BMI and musculoskeletal symptoms, with adjustment for potential confounders. Longitudinal data from the Netherlands Working Conditions Cohort Study (NWCCS) of 7,909 respondents was used for the second research aim (i.e., to investigate the transition in musculoskeletal symptoms). RESULTS: For high BMI an increased 12-month prevalence of musculoskeletal symptoms was found (overweight: OR 1.13, 95% CI: 1.08-1.19 and obesity: OR 1.28, 95% CI: 1.19-1.39). The association was modified by physical workload, with a stronger association for employees with low physical workload than for those with high physical workload. Obesity was related to developing musculoskeletal symptoms (OR 1.37, 95% CI: 1.05-1.79) and inversely related to recovery from symptoms (OR 0.76, 95% CI: 0.59-0.97). CONCLUSION: BMI was associated with musculoskeletal symptoms, in particular symptoms of the lower extremity. Furthermore, the association differed for employees with high or low physical workload. Compared to employees with normal weight, obese employees had higher risk for developing symptoms as well as less recovery from symptoms. This study supports the role of biomechanical factors for the relationship between BMI and symptoms in the lower extremity.

VIP in construction: systematic development and evaluation of a multifaceted health programme aiming to improve physical activity levels and dietary patterns among construction workers.

BACKGROUND: The prevalence of both overweight and musculoskeletal disorders (MSD) in the construction industry is high. Many interventions in the occupational setting aim at the prevention and reduction of these health problems, but it is still unclear how these programmes should be designed. To determine the effectiveness of interventions on these health outcomes randomised controlled trials (RCTs) are needed. The aim of this study is to systematically develop a tailored intervention for prevention and reduction of overweight and MSD among construction workers and to describe the evaluation study regarding its (cost-)effectiveness. METHODS/DESIGN: The Intervention Mapping (IM) protocol was applied to develop and implement a tailored programme aimed at the prevention and reduction of overweight and MSD. The (cost-) effectiveness of the intervention programme will be evaluated using an RCT. Furthermore, a process evaluation will be conducted. The research population will consist of blue collar workers of a large construction company in the Netherlands. INTERVENTION: The intervention programme will be aimed at improving (vigorous) physical activity levels and healthy dietary behaviour and will consist of tailored information, face-to-face and telephone counselling, training instruction (a fitness "card" to be used for exercises), and materials designed for the intervention (overview of the company health promoting facilities, waist circumference measuring tape, pedometer, BMI card, calorie guide, recipes, and knowledge test). MAIN STUDY PARAMETERS/ENDPOINTS: The intervention effect on body weight and waist circumference (primary outcome measures), as well as on lifestyle behaviour, MSD, fitness, CVD risk indicators, and work-related outcomes (i.e. productivity, sick leave) (secondary outcome measures) will be assessed. DISCUSSION: The development of the VIP in construction intervention led to a health programme tailored to the needs of construction workers. This programme, if proven effective, can be directly implemented. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR2095.