Behavioral sciences applied to acute care teams: a research agenda for the years ahead by a European research network.

BACKGROUND: Multi-disciplinary behavioral research on acute care teams has focused on understanding how teams work and on identifying behaviors characteristic of efficient and effective team performance. We aimed to define important knowledge gaps and establish a research agenda for the years ahead of prioritized research questions in this field of applied health research. METHODS: In the first step, high-priority research questions were generated by a small highly specialized group of 29 experts in the field, recruited from the multinational and multidisciplinary "Behavioral Sciences applied to Acute care teams and Surgery (BSAS)" research network - a cross-European, interdisciplinary network of researchers from social sciences as well as from the medical field committed to understanding the role of behavioral sciences in the context of acute care teams. A consolidated list of 59 research questions was established. In the second step, 19 experts attending the 2020 BSAS annual conference quantitatively rated the importance of each research question based on four criteria - usefulness, answerability, effectiveness, and translation into practice. In the third step, during half a day of the BSAS conference, the same group of 19 experts discussed the prioritization of the research questions in three online focus group meetings and established recommendations. RESULTS: Research priorities identified were categorized into six topics: (1) interventions to improve team process; (2) dealing with and implementing new technologies; (3) understanding and measuring team processes; (4) organizational aspects impacting teamwork; (5) training and health professions education; and (6) organizational and patient safety culture in the healthcare domain. Experts rated the first three topics as particularly relevant in terms of research priorities; the focus groups identified specific research needs within each topic. CONCLUSIONS: Based on research priorities within the BSAS community and the broader field of applied health sciences identified through this work, we advocate for the prioritization for funding in these areas.

How European Fans in Training (EuroFIT), a lifestyle change program for men delivered in football clubs, achieved its effect: a mixed methods process evaluation embedded in a randomised controlled trial.

BACKGROUND: A randomised trial of European Fans in Training (EuroFIT), a 12-week healthy lifestyle program delivered in 15 professional football clubs in the Netherlands, Norway, Portugal, and the United Kingdom, successfully increased physical activity and improved diet but did not reduce sedentary time. To guide future implementation, this paper investigates how those effects were achieved. We ask: 1) how was EuroFIT implemented? 2) what were the processes through which outcomes were achieved? METHODS: We analysed qualitative data implementation notes, observations of 29 of 180 weekly EuroFIT deliveries, semi-structured interviews with 16 coaches and 15 club representatives, and 30 focus group discussions with participants (15 post-program and 15 after 12 months). We descriptively analysed quantitative data on recruitment, attendance at sessions and logs of use of the technologies and survey data on the views of participants at baseline, post program and after 12 months. We used a triangulation protocol to investigate agreement between data from difference sources, organised around meeting 15 objectives within the two research questions. RESULTS: We successfully recruited clubs, coaches and men to EuroFIT though the draw of the football club seemed stronger in the UK and Portugal. Advertising that emphasized getting fitter, club-based deliveries, and not 'standing out' worked and attendance and fidelity were good, so that coaches in all countries were able to deliver EuroFIT flexibly as intended. Coaches in all 15 clubs facilitated the use of behaviour change techniques and interaction between men, which together enhanced motivation. Participants found it harder to change sedentary time than physical activity and diet. Fitting changes into daily routines, planning for setbacks and recognising the personal benefit of behaviour change were important to maintain changes. Bespoke technologies were valued, but technological hitches frustrated participants. CONCLUSION: EuroFIT was delivered as planned by trained club coaches working flexibly in all countries. It worked as expected to attract men and support initiation and maintenance of changes in physical activity and diet but the use of bespoke, unstable, technologies was frustrating. Future deliveries should eliminate the focus on sedentary time and should use only proven technologies to support self-monitoring and social interaction. TRIAL REGISTRATION: ISRCTN81935608, registered 16/06/2015.

Promoting an active choice among physically inactive adults: a randomised web-based four-arm experiment.

BACKGROUND: Promoting active (i.e., conscious, autonomous, informed, and value-congruent) choices may improve the effectiveness of physical activity interventions. This web-based four-arm experimental study investigated the effect of promoting an active versus passive choice regarding physical activity on behavioural and psychological outcomes (e.g., physical activity intentions and behaviours, autonomy, commitment) among physically inactive adults. METHODS: Dutch inactive adults were randomized into four groups: physical activity guideline only (control group G), guideline & information (GI), guideline & active choice (GA), or guideline & active choice & action planning (GA +). GA and GA + participants were stimulated to make an active choice by weighing advantages and disadvantages of physical activity, considering personal values, and identifying barriers. GA + participants additionally completed action/coping planning exercises. Passive choice groups G and GI did not receive exercises. Self-reported behavioural outcomes were assessed by a questionnaire pre-intervention (T0, n = 564) and at 2-4 weeks follow-up (T2, n = 493). Psychological outcomes were assessed post-intervention (T1, n = 564) and at follow-up. Regression analyses compared the outcomes of groups GI, GA and GA + with group G. We also conducted sensitivity analyses and a process evaluation. RESULTS: Although promoting an active choice process (i.e., interventions GA and GA +) did not improve intention (T1) or physical activity (T2 versus T0), GA + participants reported higher commitment at T1 (ß = 0.44;95%CI:0.04;0.84) and more frequently perceived an increase in physical activity between T0 and T2 (ß = 2.61;95%CI:1.44;7.72). GA participants also made a more active choice at T1 (ß = 0.16;95%CI:0.04;0.27). The GA and GA + intervention did not significantly increase the remaining outcomes. GI participants reported higher intention strength (ß = 0.64;95%CI:0.15;1.12), autonomy (ß = 0.50;95%CI:0.05;0.95), and commitment (ß = 0.39;95%CI:0.04;0.74), and made a more active choice at T1 (ß = 0.13;95%CI:0.02;0.24). Interestingly, gender and health condition modified the effect on several outcomes. The GA + intervention was somewhat more effective in women. The process evaluation showed that participants varied in how they perceived the intervention. CONCLUSIONS: There is no convincing evidence of a beneficial effect of an active versus passive choice intervention on physical activity intentions and behaviours among inactive adults. Further research should determine whether and how active choice interventions that are gender-sensitized and consider health conditions can effectively increase physical activity. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04973813 . Retrospectively registered.

Office workers' perspectives on physical activity and sedentary behaviour: a qualitative study.

BACKGROUND: Office workers spend a significant part of their workday sitting. Interventions that aim to reduce sedentary behaviour and increase physical activity might be more effective if greater attention is paid to individual perspectives that influence behavioural choices, including beliefs and values. This study aimed to gain insight into office workers' perspectives on physical activity and sedentary behaviour. METHODS: Sixteen Dutch office workers (50% female) from different professions participated in semi-structured face-to-face interviews in March 2019. To facilitate the interviews, participants received a sensitizing booklet one week before the interview. The booklet aimed to trigger them to reflect on their physical activity and sedentary behaviour and on their values in life. All interviews were audiotaped, transcribed verbatim and coded following codebook thematic analysis. RESULTS: Six themes were identified: 1) beliefs about health effects are specific regarding physical activity, but superficial regarding sedentary behaviour; 2) in addition to 'health' as a value, other values are also given priority; 3) motivations to engage in physical activity mainly stem from prioritizing the value 'health', reflected by a desire to both achieve positive short/mid-term outcomes and to prevent long-term negative outcomes; 4) attitudes towards physical inactivity and sedentary behaviour are diverse and depend on individual values and previous experiences; 5) perceived barriers depend on internal and external factors; 6) supporting factors are related to support and information in the social and physical environment. CONCLUSIONS: The great value that office workers attach to health is reflected in their motivations and attitudes regarding physical activity. Increasing office workers' knowledge of the health risks of prolonged sitting may therefore increase their motivation to sit less. Although 'health' is considered important, other values, including social and work-related values, are sometimes prioritized. We conclude that interventions that aim to reduce sedentary behaviour and increase physical activity among office workers could be improved by informing about health effects of sedentary behaviour and short/mid-term benefits of physical activity, including mental health benefits. Moreover, interventions could frame physical activity as congruent with values and support value-congruent choices. Finally, the work environment could support physical activity and interruption of sedentary behaviour.

Barriers and facilitators influencing the implementation of the occupational health intervention 'Dynamic Work': a qualitative study.

BACKGROUND: Sedentary behavior is associated with an increased risk of morbidity and mortality. To reduce occupational sitting time of office workers, the multi-component intervention 'Dynamic Work' was implemented in a Dutch insurance company. Although the results showed no significant reductions in sitting time, associations were found between higher levels of implementation and reductions in sitting time. Building upon these findings, this qualitative study aimed to identify barriers and facilitators from an organizational perspective for the implementation of Dynamic Work. In addition, we explored differences in barriers and facilitators between departments with a low, middle and high level of implementation. METHODS: In total, eighteen semi-structured interviews were conducted with two Dynamic Work coordinators, three occupational physiotherapists who delivered the intervention, and thirteen department managers. All participants were purposively sampled. The data was coded in Atlas.ti and a thematic analysis was performed guided by The Integrated Checklist of Determinants (TICD). RESULTS: Implementation factors were related to the organization; working culture and financial support facilitated implementation. Factors related to the implementing department mainly hindered implementation, i.e. lack of information at start of the project, late delivery of Dynamic Work equipment, large group sizes, employee's workload and work tasks, and an ongoing reorganization. The facilitating role of managers was experienced as both enabling and hindering. The pre-existing familiarity of the occupational physiotherapists with the departments and alignment amongst the three implementers facilitated implementation. Yet, the non-obligatory nature of the intervention as well as limited availability and technical problems of equipment did not support implementation. CONCLUSIONS: Various barriers and facilitators influenced the implementation of the Dynamic Work intervention, where the key role of the department manager, late delivery of dynamic work equipment and groups sizes varied between low and high implementing departments. These results can contribute to developing and improving implementation strategies in order to increase the effectiveness of future occupational health interventions. TRIAL REGISTRATION: The study protocol was registered on April 14, 2017 in the ClinicalTrials.gov Protocol Registration and Results System under registration number NCT03115645 .

Less sedentary time is associated with a more favourable glucose-insulin axis in obese pregnant women-a secondary analysis of the DALI study.

BACKGROUND/OBJECTIVES: Obese pregnant women are at high risk of developing gestational diabetes mellitus (GDM), which might be reduced by sufficient physical activity (PA) and reduced sedentary time (ST). We assessed whether PA and ST are longitudinally associated with the glucose-insulin axis in obese pregnant women. SUBJECTS/METHODS: In this secondary analysis of the DALI (vitamin D And Lifestyle Intervention for gestational diabetes mellitus prevention) study, pregnant women, <20 weeks gestation, with a pre-pregnancy body mass index (BMI) ≥ 29 kg/m2, without GDM on entry were included. Time spent in moderate-to-vigorous PA (MVPA) and ST were measured objectively with accelerometers at <20 weeks, 24-28 weeks and 35-37 weeks of gestation. Fasting glucose (mmol/l) and insulin (mU/l), insulin resistance (HOMA-IR) and first-phase and second-phase insulin release (Stumvoll first and second phase) were assessed at the same time. Linear mixed regression models were used to calculate between-participant differences and within-participant changes over time. Analyses were adjusted for gestational age, randomisation, pre-pregnancy BMI, education and age. MVPA, Insulin, HOMA-IR and Stumvoll first and second phase were log-transformed for analyses due to skewness. RESULTS: 232 women were included in the analysis. Concerning differences between participants, more ST was associated with higher fasting glucose (Estimate: 0.008; 95% CI: 0.002, 0.014), fasting insulin (0.011; 0.002, 0.019), HOMA-IR (0.012; 0.004, 0.021) and Stumvoll first and second phase (0.008; 0.001, 0.014 and 0.007; 0.001, 0.014). Participants with more MVPA had lower Stumvoll first and second phase (-0.137; -0.210, -0.064 and -0.133; -0.202, -0.063). Concerning changes over time, an increase in ST during gestation was associated with elevated Stumvoll first and second phase (0.006; 0.000, 0.011). CONCLUSIONS: As the glucose-insulin axis is more strongly associated with ST than MVPA in our obese population, pregnant women could be advised to reduce ST in addition to increasing MVPA. Moreover, our findings suggest that behaviour change interventions aiming at GDM risk reduction should start in early or pre-pregnancy.

Contributions of changes in physical activity, sedentary time, diet and body weight to changes in cardiometabolic risk.

BACKGROUND: Increased physical activity (PA), reduced time spent sedentary (SED), healthier diet and reduced body weight may all have a positive impact on cardiometabolic risk. The relative importance of change in each of these variables on cardiometabolic risk, however, is unclear. We therefore sought to investigate the relative contributions of changes in PA, SED, diet and body weight on cardiometabolic risk. METHODS: This is a secondary analysis of data collected from the EuroFIT randomised controlled trial, which was a 12-week group-based lifestyle intervention for overweight middle-aged men delivered by coaches in football club stadia aiming to improve PA, SED, diet, and body weight. PA and SED were assessed by accelerometry, diet using the Dietary Instrument for Nutrition Education (DINE). An overall cardiometabolic risk score was derived from combining z-scores for glucose, HbA1c, insulin, lipids and blood pressure. In total, 707 men (from the overall cohort of 1113) with complete data for these variables at baseline and 12-month follow-up were included in the multivariable linear regression analyses. RESULTS: In multivariable analyses, change in number of steps (explaining 5.1% of R2) and dietary factors (less alcohol, fatty and sugary food, and more fruit and vegetables) (together explaining 4.5% of R2), but not changes in standing time or SED, were significantly associated with change in body weight. Changes in number of steps (R2 = 1.7%), fatty food score (R2 = 2.4%), and sugary food score (R2 = 0.4%) were significantly associated with change in cardiometabolic risk score in univariable models. However, in multivariable models which included changes in weight as well as changes in steps and dietary variables, change in weight explained a substantially larger proportion of the change in cardiometabolic risk score, explaining 14.1% of R2 (out of an overall model R2 of 19.0%). When baseline (as well as change) values were also included in the model, 38.8% of R2 for change in cardiometabolic risk score was explained overall, with 14.1% of R2 still explained by change in weight. CONCLUSION: Change in body weight, together with baseline cardiometabolic risk explained most of the change in cardiometabolic risk. Thus, the benefits of increasing physical activity and improving diet on cardiometabolic risk appear to act largely via an effect on changes in body weight. TRIAL REGISTRATION: International Standard Randomised Controlled Trials, ISRCTN-81935608. Registered 06052015. https://www.isrctn.com/ISRCTN81935608?q=&filters=recruitmentCountry:Portugal&sort=&offset=7&totalResults=92&page=1&pageSize=10&searchType=basic-search.

The importance of maternal insulin resistance throughout pregnancy on neonatal adiposity.

BACKGROUND: Although previous studies evaluated the association of maternal health parameters with neonatal adiposity, little is known regarding the complexity of the relationships among different maternal health parameters throughout pregnancy and its impact on neonatal adiposity. OBJECTIVES: To evaluate the direct and indirect associations between maternal insulin resistance during pregnancy, in women with obesity, and neonatal adiposity. In addition, associations between maternal fasting glucose, triglycerides (TG), non-esterified fatty acids (NEFA), and neonatal adiposity were also assessed. METHODS: This is a longitudinal, secondary analysis of the DALI study, an international project conducted in nine European countries with pregnant women with obesity. Maternal insulin resistance (HOMA-IR), fasting glucose, TG, and NEFA were measured three times during pregnancy (<20, 24-28, and 35-37 weeks of gestation). Offspring neonatal adiposity was estimated by the sum of four skinfolds. Structural equation modelling was conducted to evaluate the direct and indirect relationships among the variables of interest. RESULTS: Data on 657 mother-infant pairs (50.7% boys) were analysed. Neonatal boys exhibited lower mean sum of skinfolds compared to girls (20.3 mm, 95% CI 19.7, 21.0 vs 21.5 mm, 95% CI 20.8, 22.2). In boys, maternal HOMA-IR at <20 weeks was directly associated with neonatal adiposity (ß = 0.35 mm, 95% CI 0.01, 0.70). In girls, maternal HOMA-IR at 24-28 weeks was only indirectly associated with neonatal adiposity, which implies that this association was mediated via maternal HOMA-IR, glucose, triglycerides, and NEFA during pregnancy (ß = 0.26 mm, 95% CI 0.08, 0.44). CONCLUSIONS: The timing of the role of maternal insulin resistance on neonatal adiposity depends on fetal sex. Although the association was time-dependent, maternal insulin resistance was associated with neonatal adiposity in both sexes.

Choice architecture interventions to change physical activity and sedentary behavior: a systematic review of effects on intention, behavior and health outcomes during and after intervention.

BACKGROUND: Choice architecture interventions, which subtly change the environment in which individuals make decisions, can be used to promote behavior change. This systematic review aimed to summarize studies on micro-environmental choice architecture interventions that encouraged physical activity or discouraged sedentary behavior in adults, and to describe the effectiveness of those interventions on these behaviors - and on related intentions or health outcomes - in presence of the intervention and after removal of the intervention (i.e. post-intervention, regardless of the time elapsed). METHODS: We systematically searched PubMed, Embase, PsycINFO and the Cochrane Library for (quasi) experimental studies published up to December 2019 that evaluated the effect of choice architecture interventions on physical activity and sedentary behavior, as well as on intentions and health outcomes related to physical activity/sedentary behavior. Studies that combined choice architecture techniques with other behavior change techniques were excluded. All studies were screened for eligibility, relevant data was extracted and two independent reviewers assessed the methodological quality using the QualSyst tool. RESULTS: Of the 9609 records initially identified, 88 studies met our eligibility criteria. Most studies (n = 70) were of high methodologic quality. Eighty-six studies targeted physical activity, predominantly stair use, whereas two studies targeted sedentary behavior, and one targeted both behaviors. Intervention techniques identified were prompting (n = 53), message framing (n = 24), social comparison (n = 12), feedback (n = 8), default change (n = 1) and anchoring (n = 1). In presence of the intervention, 68% of the studies reported an effect of choice architecture on behavior, whereas after removal of the intervention only 47% of the studies reported a significant effect. For all choice architecture techniques identified, except for message framing, the majority of studies reported a significant effect on behavioral intentions or behavior in presence of the intervention. CONCLUSIONS: The results suggest that prompting can effectively encourage stair use in adults, especially in presence of a prompt. The effectiveness of the choice architecture techniques social influence, feedback, default change and anchoring cannot be assessed based on this review. More (controlled) studies are needed to assess the (sustained) effectiveness of choice architecture interventions on sedentary behavior and other types of physical activity than stair use.

Five-year cost-effectiveness analysis of the European Fans in Training (EuroFIT) physical activity intervention for men versus no intervention.

OBJECTIVES: Increasing physical activity reduces the risk of chronic illness including Type 2 diabetes, cardiovascular disease and certain types of cancer. Lifestyle interventions can increase physical activity but few successfully engage men. This study aims to investigate the 5 year cost-effectiveness of EuroFIT, a program to improve physical activity tailored specifically for male football (soccer) fans compared to a no intervention comparison group. METHODS: We developed a Markov cohort model in which the impact of improving physical activity on five chronic health conditions (colorectal cancer, Type 2 diabetes, coronary heart disease, stroke and depression) and mortality was modelled. We estimated costs from a societal perspective and expressed benefits as quality adjusted life years (QALYs). We obtained data from a 4-country (England, Netherlands, Portugal and Norway) pragmatic randomised controlled trial evaluating EuroFIT, epidemiological and cohort studies, and meta-analyses. We performed deterministic and probabilistic sensitivity analyses to assess the impact of uncertainty in the model's parameter values on the cost-effectiveness results. We used Monte Carlo simulations to estimate uncertainty and presented this using cost-effectiveness acceptability curves (CEACs). We tested the robustness of the base case analysis using five scenario analyses. RESULTS: Average costs over 5 years per person receiving EuroFIT were €14,663 and per person receiving no intervention €14,598. Mean QALYs over 5 years were 4.05 per person for EuroFIT and 4.04 for no intervention. Thus, the average incremental cost per person receiving EuroFIT was €65 compared to no intervention, while the average QALY gain was 0.01. This resulted in an ICER of €5206 per QALY gained. CEACs show that the probability of EuroFIT being cost-effective compared to no intervention is 0.53, 0.56 and 0.58 at thresholds of €10,000, €22,000 and €34,000 per QALY gained, respectively. When using a time horizon of 10 years, the results suggest that EuroFIT is more effective and less expensive compared to (i.e. dominant over) no intervention with a probability of cost-effectiveness of 0.63 at a threshold of €22,000 per QALY gained. CONCLUSIONS: We conclude the EuroFIT intervention is not cost-effective compared to no intervention over a period of 5 years from a societal perspective, but is more effective and less expensive (i.e. dominant) after 10 years. We thus suggest that EuroFIT can potentially improve public health in a cost-effective manner in the long term.

Efficacy of a physical activity programme combining individualized aerobic exercise and coaching to improve physical fitness in neuromuscular diseases (I'M FINE): study protocol of a randomized controlled trial.

BACKGROUND: In individuals with neuromuscular diseases (NMD), symptoms of muscle weakness, fatigue and pain may limit physical activity. Inactivity leads to reduced physical fitness, which further complicates daily life functioning. Due to inconclusive evidence regarding exercise in NMD, the optimal training approach and strategies to preserve an active lifestyle remain to be determined. The physical activity programme I'M FINE, consisting of individualized aerobic exercise to improve physical fitness and coaching to preserve an active lifestyle, was therefore developed. The primary objective of this study will be to evaluate the efficacy of the I'M FINE programme in terms of improved physical fitness in individuals with slowly progressive NMD, compared to usual care. METHODS: A multicentre, assessor-blinded, two armed, randomized controlled trial will be conducted in a sample of 90 individuals with slowly progressive NMD. Participants motivated to improve their reduced physical fitness will be randomized (ratio 1:1) to the I'M FINE intervention or usual care. The I'M FINE intervention consists of a six-month physical activity programme, including individualized home-based aerobic exercise to improve physical fitness (i.e. peak oxygen uptake), and motivational interviewing coaching (e.g. goal setting, self-management) to adopt and preserve an active lifestyle. Measurements will be performed at baseline, post-intervention, and at 12- and 18-months follow-up. The primary outcome is peak oxygen uptake (VO2 peak) directly post intervention. Main secondary outcomes are physical capacity, muscle strength, self-efficacy, daily activity, quality of life and markers of metabolic syndrome. The primary analysis compares change in VO2 peak post-intervention between the intervention and usual care group, with analysis of covariance. DISCUSSION: The I'M FINE study will provide evidence regarding the efficacy of a physical activity intervention on the physical fitness and active lifestyle over the short- and long-term in individuals with slowly progressive NMD. These outcomes could potentially improve the (inter)national guidelines for efficacy of aerobic exercise programmes and provide insight in achieving a more active lifestyle in NMD. TRIAL REGISTRATION: (5/11/2018): Netherlands Trial Register NTR7609 (retrospectively registered), https://www.trialregister.nl/trial/7344. However, the Ethics Review Committee of the Amsterdam Medical Center (AMC) approved the study protocol on 7/11/2017. No adjustments were made to the approved study protocol before the first participant enrolment and registration. Registration was done after the second participant enrolment and the information in the register corresponds one on one with the approved study protocol.

A reduction in sedentary behaviour in obese women during pregnancy reduces neonatal adiposity: the DALI randomised controlled trial.

AIMS/HYPOTHESIS: Offspring of obese women are at increased risk of features of the metabolic syndrome, including obesity and diabetes. Lifestyle intervention in pregnancy might reduce adverse effects of maternal obesity on neonatal adiposity. METHODS: In the Vitamin D And Lifestyle Intervention for Gestational Diabetes Mellitus (GDM) Prevention (DALI) lifestyle trial, 436 women with a BMI ≥29 kg/m2 were randomly assigned to counselling on healthy eating (HE), physical activity (PA) or HE&PA, or to usual care (UC). In secondary analyses of the lifestyle trial, intervention effects on neonatal outcomes (head, abdominal, arm and leg circumferences and skinfold thicknesses, estimated fat mass, fat percentage, fat-free mass and cord blood leptin) were assessed using multilevel regression analyses. Mediation of intervention effects by lifestyle and gestational weight gain was assessed. RESULTS: Outcomes were available from 334 neonates. A reduction in sum of skinfolds (-1.8 mm; 95% CI -3.5, -0.2; p = 0.03), fat mass (-63 g; 95% CI -124, -2; p = 0.04), fat percentage (-1.2%; 95% CI -2.4%, -0.04%; p = 0.04) and leptin (-3.80 µg/l; 95% CI -7.15, -0.45; p = 0.03) was found in the HE&PA group, and reduced leptin in female neonates in the PA group (-5.79 µg/l; 95% CI -11.43, -0.14; p = 0.05) compared with UC. Reduced sedentary time, but not gestational weight gain, mediated intervention effects on leptin in both the HE&PA and PA groups. CONCLUSIONS/INTERPRETATION: The HE&PA intervention resulted in reduced adiposity in neonates. Reduced sedentary time seemed to drive the intervention effect on cord blood leptin. Implications for future adiposity and diabetes risk of the offspring need to be elucidated. TRIAL REGISTRATION: ISRCTN70595832.

Correction: The effect of a programme to improve men's sedentary time and physical activity: The European Fans in Training (EuroFIT) randomised controlled trial.

[This corrects the article DOI: 10.1371/journal.pmed.1002736.].

The effect of a programme to improve men's sedentary time and physical activity: The European Fans in Training (EuroFIT) randomised controlled trial.

BACKGROUND: Reducing sitting time as well as increasing physical activity in inactive people is beneficial for their health. This paper investigates the effectiveness of the European Fans in Training (EuroFIT) programme to improve physical activity and sedentary time in male football fans, delivered through the professional football setting. METHODS AND FINDINGS: A total of 1,113 men aged 30-65 with self-reported body mass index (BMI) ≥27 kg/m2 took part in a randomised controlled trial in 15 professional football clubs in England, the Netherlands, Norway, and Portugal. Recruitment was between September 19, 2015, and February 2, 2016. Participants consented to study procedures and provided usable activity monitor baseline data. They were randomised, stratified by club, to either the EuroFIT intervention or a 12-month waiting list comparison group. Follow-up measurement was post-programme and 12 months after baseline. EuroFIT is a 12-week, group-based programme delivered by coaches in football club stadia in 12 weekly 90-minute sessions. Weekly sessions aimed to improve physical activity, sedentary time, and diet and maintain changes long term. A pocket-worn device (SitFIT) allowed self-monitoring of sedentary time and daily steps, and a game-based app (MatchFIT) encouraged between-session social support. Primary outcome (objectively measured sedentary time and physical activity) measurements were obtained for 83% and 85% of intervention and comparison participants. Intention-to-treat analyses showed a baseline-adjusted mean difference in sedentary time at 12 months of -1.6 minutes/day (97.5% confidence interval [CI], -14.3-11.0; p = 0.77) and in step counts of 678 steps/day (97.5% CI, 309-1.048; p < 0.001) in favor of the intervention. There were significant improvements in diet, weight, well-being, self-esteem, vitality, and biomarkers of cardiometabolic health in favor of the intervention group, but not in quality of life. There was a 0.95 probability of EuroFIT being cost-effective compared with the comparison group if society is willing to pay £1.50 per extra step/day, a maximum probability of 0.61 if society is willing to pay £1,800 per minute less sedentary time/day, and 0.13 probability if society is willing to pay £30,000 per quality-adjusted life-year (QALY). It was not possible to blind participants to group allocation. Men attracted to the programme already had quite high levels of physical activity at baseline (8,372 steps/day), which may have limited room for improvement. Although participants came from across the socioeconomic spectrum, a majority were well educated and in paid work. There was an increase in recent injuries and in upper and lower joint pain scores post-programme. In addition, although the five-level EuroQoL questionnaire (EQ-5D-5L) is now the preferred measure for cost-effectiveness analyses across Europe, baseline scores were high (0.93), suggesting a ceiling effect for QALYs. CONCLUSION: Participation in EuroFIT led to improvements in physical activity, diet, body weight, and biomarkers of cardiometabolic health, but not in sedentary time at 12 months. Within-trial analysis suggests it is not cost-effective in the short term for QALYs due to a ceiling effect in quality of life. Nevertheless, decision-makers may consider the incremental cost for increase in steps worth the investment. TRIAL REGISTRATION: International Standard Randomised Controlled Trials, ISRCTN-81935608.

Prevalence and correlates of domain-specific sedentary time of adults in the Netherlands: findings from the 2006 Dutch time use survey.

BACKGROUND: Relatively little is known about how total sedentary time is accumulated in different domains and if correlates of sedentary time differ across domains. Time use surveys present a unique opportunity to study sedentary time in more detail. This study aimed to use the 2006 Dutch time use survey to 1) describe the (sedentary) time use of Dutch adults, and 2) explore socio-demographic and health-related correlates of total (non-occupational) and domain-specific sedentary time. METHODS: The Dutch time use survey randomly selected participants from a population-representative research sample of Dutch households. Participants reported daily activities on seven consecutive days using a time use diary and socio-demographic and health-related characteristics during telephone interviews. All reported activities were coded for activity domain (i.e. education; household; leisure; occupation; sleep; transport; voluntary work) and activity intensity (i.e. sedentary; light intensity physical activity; moderate-to-vigorous intensity physical activity). As occupational activities were not specified in sufficient detail, the intensity of these activities was unknown. We described the time spent in different domains and intensities, and assessed the socio-demographic and health-related correlates of high levels of total (non-occupational), household, leisure, and transport sedentary time using logistic regression analyses. RESULTS: The final dataset consisted of 1614 adult (18+) participants. On average, participants spent 8.0 h (61.1%) of their daily waking non-occupational time on sedentary activities. More than 87% of leisure time was spent sedentary. Men, participants aged 18-34 and 65+ years, full-time employed participants and obese participants had higher levels of total non-occupational sedentary time. The correlates of household, leisure and transport sedentary time differed by domain. CONCLUSIONS: This study reports high levels of total non-occupational sitting time of Dutch adults. The large proportion of sedentary leisure activities might indicate the potential of strategies aiming to reduce leisure sedentary time. The difference in correlates across sedentary behaviour domains demonstrates the importance of targeting these domains differently in interventions and policies.

The Dynamic Work study: study protocol of a cluster randomized controlled trial of an occupational health intervention aimed at reducing sitting time in office workers.

BACKGROUND: Large volumes of sitting time have been associated with multiple health risks. To reduce sitting time of office workers working for a Dutch insurance company, the Dynamic Work intervention was developed. The primary objective of this paper is to describe the study protocol of the Dynamic Work study, which aims to evaluate if this multicomponent intervention is (cost-)effective in reducing total sitting time on the short-term (≈3 months) and longer-term (≈12 months) compared to usual practice. METHODS/DESIGN: This two-arm cluster randomized controlled trial will recruit 250 desk-based office workers working at different locations of an insurance company in the Netherlands. After baseline measurements, departments will be matched in pairs and each pair will be randomly assigned to the control or intervention condition. The multicomponent intervention contains organizational (i.e. face to face session with the head of the department), work environmental (i.e. the introduction of sit-stand desks and cycling workstations), and individual elements (i.e. counselling and activity/sitting tracker with a self-help program booklet). The counselling involves two group intervention sessions and four on-site department consultations with an occupational physiotherapist. Sitting time (primary outcome), upright time and step counts will be assessed objectively using the activPAL activity monitor at baseline, short-term (approximately 3 months) and longer-term (12 months). Other outcomes will include: self-reported lifestyle behaviours, anthropometrics, work-related outcomes (i.e. absenteeism, presenteeism, work performance, work-related stress), health-related outcomes (i.e. vitality, musculoskeletal symptoms, need for recovery, quality of life), and costs from both company and societal perspective. The study will include economic and process evaluations. DISCUSSION: This study will assess the longer-term (cost-) effectiveness of a multicomponent workplace intervention aimed at reducing sitting time in comparison with usual practice. Furthermore, the process evaluation will provide insights in factors associated with successful implementation of this intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT03115645 ; Registered 13 April 2017. Retrospectively registered.

Changing psychosocial determinants of physical activity and diet in women with a history of gestational diabetes mellitus.

BACKGROUND: To investigate how a behavioural lifestyle intervention influences psychosocial determinants of physical activity and dietary behaviours in a population at risk of type 2 diabetes (T2DM). METHODS: Fifty-nine women with a body mass index of ≥25 kg/m2 and a history of gestational diabetes mellitus (GDM) participated in a randomized controlled study. The intervention group (n = 29) received 2 face-to-face and 5 telephone lifestyle-counselling sessions with a health professional. The control group (n = 30) received care as usual. At baseline and 6 months, psychosocial determinants related to physical activity and diet were measured with a self-administrated questionnaire. Linear regression analyses were applied to test for intervention effects. RESULTS: The intervention was effective in improving social support (ß = 3.5, P < 0.001; ß = 2.1, P = 0.02), modifying self-efficacy (ß = -2.2, P = 0.02; ß = -4.3, P < 0.001), and reducing barriers (ß = -3.5, P = 0.01; ß = -3.8, P = 0.01) for, respectively, physical activity and diet from baseline to 6-month follow-up in the intervention group compared with the control group. The intervention reduced the following barriers to a physically active lifestyle: lack of energy and lack of motivation. Physical activity barriers like lack of time and lack of childcare were unchanged. The intervention reduced the following barriers to a healthy diet: lack of time, costs, having unhealthy snacks at home, and having cravings for sweets. CONCLUSION: This lifestyle intervention influenced psychosocial determinants relevant for overweight women with a history of gestational diabetes mellitus (GDM) in prevention of T2DM.

Cost-effectiveness of healthy eating and/or physical activity promotion in pregnant women at increased risk of gestational diabetes mellitus: economic evaluation alongside the DALI study, a European multicenter randomized controlled trial.

BACKGROUND: Gestational diabetes mellitus (GDM) is associated with perinatal health risks to both mother and offspring, and represents a large economic burden. The DALI study is a multicenter randomized controlled trial, undertaken to add to the knowledge base on the effectiveness of interventions for pregnant women at increased risk for GDM. The purpose of this study was to evaluate the cost-effectiveness of the healthy eating and/or physical activity promotion intervention compared to usual care among pregnant women at increased risk of GDM from a societal perspective. METHODS: An economic evaluation was performed alongside a European multicenter-randomized controlled trial. A total of 435 pregnant women at increased risk of GDM in primary and secondary care settings in nine European countries, were recruited and randomly allocated to a healthy eating and physical activity promotion intervention (HE + PA intervention), a healthy eating promotion intervention (HE intervention), or a physical activity promotion intervention (PA intervention). Main outcome measures were gestational weight gain, fasting glucose, insulin resistance (HOMA-IR), quality adjusted life years (QALYs), and societal costs. RESULTS: Between-group total cost and effect differences were not significant, besides significantly less gestational weight gain in the HE + PA group compared with the usual care group at 35-37 weeks (-2.3;95%CI:-3.7;-0.9). Cost-effectiveness acceptability curves indicated that the HE + PA intervention was the preferred intervention strategy. At 35-37 weeks, it depends on the decision-makers' willingness to pay per kilogram reduction in gestational weight gain whether the HE + PA intervention is cost-effective for gestational weight gain, whereas it was not cost-effective for fasting glucose and HOMA-IR. After delivery, the HE + PA intervention was cost-effective for QALYs, which was predominantly caused by a large reduction in delivery-related costs. CONCLUSIONS: Healthy eating and physical activity promotion was found to be the preferred strategy for limiting gestational weight gain. As this intervention was cost-effective for QALYs after delivery, this study lends support for broad implementation. TRIAL REGISTRATION: ISRCTN ISRCTN70595832 . Registered 2 December 2011.

Epidemiology of gestational diabetes mellitus according to IADPSG/WHO 2013 criteria among obese pregnant women in Europe.

AIMS/HYPOTHESIS: Accurate prevalence estimates for gestational diabetes mellitus (GDM) among pregnant women in Europe are lacking owing to the use of a multitude of diagnostic criteria and screening strategies in both high-risk women and the general pregnant population. Our aims were to report important risk factors for GDM development and calculate the prevalence of GDM in a cohort of women with BMI ≥29 kg/m2 across 11 centres in Europe using the International Association of the Diabetes and Pregnancy Study Groups (IADPSG)/WHO 2013 diagnostic criteria. METHODS: Pregnant women (n = 1023, 86.3% European ethnicity) with a BMI ≥29.0 kg/m2 enrolled into the Vitamin D and Lifestyle Intervention for GDM Prevention (DALI) pilot, lifestyle and vitamin D studies of this pan-European multicentre trial, attended for an OGTT during pregnancy. Demographic, anthropometric and metabolic data were collected at enrolment and throughout pregnancy. GDM was diagnosed using IADPSG/WHO 2013 criteria. GDM treatment followed local policies. RESULTS: The number of women recruited per country ranged from 80 to 217, and the dropout rate was 7.1%. Overall, 39% of women developed GDM during pregnancy, with no significant differences in prevalence across countries. The prevalence of GDM was high (24%; 242/1023) in early pregnancy. Despite interventions used in the DALI study, a further 14% (94/672) had developed GDM when tested at mid gestation (24-28 weeks) and 13% (59/476) of the remaining cohort at late gestation (35-37 weeks). Demographics and lifestyle factors were similar at baseline between women with GDM and those who maintained normal glucose tolerance. Previous GDM (16.5% vs 7.9%, p = 0.002), congenital malformations (6.4% vs 3.3%, p = 0.045) and a baby with macrosomia (31.4% vs 17.9%, p = 0.001) were reported more frequently in those who developed GDM. Significant anthropometric and metabolic differences were already present in early pregnancy between women who developed GDM and those who did not. CONCLUSIONS/INTERPRETATION: The prevalence of GDM diagnosed by the IADPSG/WHO 2013 GDM criteria in European pregnant women with a BMI ≥29.0 kg/m2 is substantial, and poses a significant health burden to these pregnancies and to the future health of the mother and her offspring. Uniform criteria for GDM diagnosis, supported by robust evidence for the benefits of treatment, are urgently needed to guide modern GDM screening and treatment strategies.

Is a motivational interviewing based lifestyle intervention for obese pregnant women across Europe implemented as planned? Process evaluation of the DALI study.

BACKGROUND: Process evaluation is an essential part of designing and assessing complex interventions. The vitamin D and lifestyle intervention study (DALI) study is testing different strategies to prevent development of gestational diabetes mellitus among European obese pregnant women with a body mass index ≥29 kg/m2. The intervention includes guidance on physical activity and/or healthy eating by a lifestyle coach trained in motivational interviewing (MI). The aim of this study was to assess the process elements: reach, dose delivered, fidelity and satisfaction and to investigate whether these process elements were associated with changes in gestational weight gain (GWG). METHODS: Data on reach, dose delivered, fidelity, and satisfaction among 144 participants were collected. Weekly recruitment reports, notes from meetings, coach logs and evaluation questionnaires (n = 110) were consulted. Fidelity of eight (out of twelve) lifestyle coach practitioners was assessed by analysing audio recorded counselling sessions using the MI treatment integrity scale. Furthermore, associations between process elements and GWG were assessed with linear regression analyses. RESULTS: A total of 20% of the possible study population (reach) was included in this analysis. On average 4.0 (of the intended 5) face-to-face sessions were delivered. Mean MI fidelity almost reached 'expert opinion' threshold for the global scores, but was below 'beginning proficiency' for the behavioural counts. High variability in quality of MI between practitioners was identified. Participants were highly satisfied with the intervention, the lifestyle coach and the intervention materials. No significant associations were found between process elements and GWG. CONCLUSION: Overall, the intervention was well delivered and received by the study population, but did not comply with all the principles of MI. Ensuring audio recording of lifestyle sessions throughout the study would facilitate provision of individualized feedback to improve MI skills. A larger sample size is needed to confirm the lack of association between process elements and GWG. TRIAL REGISTRATION: ISRCTN registry: ISRCTN70595832 ; Registered 12 December 2011.