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1.  Biological, socio-demographic, work and lifestyle determinants of sitting in young adult women: a prospective cohort study 
Background
Sitting is associated with health risks. Factors that influence sitting are however not well understood. The aim was to examine the biological, socio-demographic, work-related and lifestyle determinants of sitting time (including during transport, work and leisure) in young adult Australian women.
Methods
Self-reported data from 11,676 participants (aged 22–27 years in 2000) in the Australian Longitudinal Study on Women’s Health were collected over 9 years in 2000, 2003, 2006 and 2009. Generalised Estimating Equations were used to examine univariable and multivariable associations of body mass index (BMI), country of birth, area of residence, education, marital status, number of children, occupational status, working hours, physical activity, smoking, alcohol intake and stress with week- and weekend-day sitting time.
Results
Compared with women in the respective referent categories, (1) women with higher BMI, those born in Asia, those with less than University level education, doing white collar work, working 41–48 hours a week, current smokers, non, rare or risky/high risk drinkers and those being somewhat stressed had significantly higher sitting time; and (2) women living in rural and remote areas, partnered women, those with children, those without a paid job and blue collar workers, those working less than 34 hours a week, and active women had significantly lower sitting time.
Conclusions
Among young adult Australian women, those with higher BMI, those born in Asia, those with higher level occupations and long working hours, were most at risk of higher sitting time. These results can be used to identify at-risk groups and inform intervention development.
doi:10.1186/1479-5868-11-7
PMCID: PMC3904408  PMID: 24457004
Epidemiology; Prospective studies; Sedentary lifestyle; Women’s health
2.  The implementation effectiveness of the ‘Strengthen your ankle’ smartphone application for the prevention of ankle sprains: design of a randomized controlled trial 
Background
Ankle sprains continue to pose a significant burden to the individual athlete, as well as to society as a whole. However, despite ankle sprains being the single most common sports injury and despite an active approach by various Dutch organisations in implementing preventive measures, large-scale community uptake of these preventive measures, and thus actual prevention of ankle sprains, is lagging well behind. In an attempt to bridge this implementation gap, the Dutch Consumer Safety Institute VeiligheidNL developed a freely available interactive App (‘Strenghten your ankle’ translated in Dutch as: ‘Versterk je enkel; available for iOS and Android) that contains - next to general advice on bracing and taping - a proven cost-effective neuromuscular program. The ‘Strengthen your ankle’ App has not been evaluated against the ‘regular’ prevention approach in which the neuromuscular program is advocated through written material. The aim of the current project is to evaluate the implementation value of the ‘Strengthen your ankle’ App as compared to the usual practice of providing injured athletes with written materials. In addition, as a secondary outcome measure, the cost-effectiveness will be assessed against usual practice.
Methods/Design
The proposed study will be a randomised controlled trial. After stratification for medical caregiver, athletes will be randomised to two study groups. One group will receive a standardized eight-week proprioceptive training program that has proven to be cost-effective to prevent recurrent ankle injuries, consisting of a balance board (machU/ MSG Europe BVBA), and a traditional instructional booklet. The other group will receive the same exercise program and balance board. However, for this group the instructional booklet is exchanged by the interactive ‘Strengthen your ankle’ App.
Discussion
This trial is the first randomized controlled trial to study the implementation effectiveness of an App for proprioceptive balance board training program in comparison to a traditional printed instruction booklet, with the recurrence of ankle sprains among athletes as study outcome. Results of this study could possibly lead to changes in practical guidelines on the treatment of ankle sprains and in the use of mobile applications for injury prevention. Results will become available in 2014.
Trial registration
The Netherlands National Trial Register NTR4027. The NTR is part of the WHO Primary Registries.
doi:10.1186/1471-2474-15-2
PMCID: PMC3923004  PMID: 24393146
Mobile health; Ankle sprains; Ankle injury; Prevention; Neuromuscular training
3.  Associations between overweight, obesity, health measures and need for recovery in office employees: a cross-sectional analysis 
BMC Public Health  2013;13:1207.
Background
With both a high need for recovery (NFR) and overweight and obesity being a potential burden for organizations (e.g. productivity loss and sickness absence), the aim of this paper was to examine the associations between overweight and obesity and several other health measures and NFR in office workers.
Methods
Baseline data of 412 office employees participating in a randomised controlled trial aimed at improving NFR in office workers were used. Associations between self-reported BMI categories (normal body weight, overweight, obesity) and several other health measures (general health, mental health, sleep quality, stress and vitality) with NFR were examined. Unadjusted and adjusted linear regression analyses were performed and adjusted for age, education and job demands. In addition, we adjusted for general health in the association between overweight and obesity and NFR.
Results
A significant positive association was observed between stress and NFR (B = 18.04, 95%CI:14.53-21.56). General health, mental health, sleep quality and vitality were negatively associated with NFR (p < 0.001). Analyses also showed a significant positive association between obesity and NFR (B = 8.77, 95%CI:0.01-17.56), but not between overweight and NFR.
Conclusions
The findings suggest that self-reported stress is, and obesity may be, associated with a higher NFR. Additionally, the results imply that health measures that indicate a better health are associated with a lower NFR.
Trial registration
The trial is registered at the Dutch Trial Register (NTR) under trial registration number: NTR2553.
doi:10.1186/1471-2458-13-1207
PMCID: PMC3890611  PMID: 24359267
Cross-sectional study; Need for recovery; Employees; Overweight; Obesity; Health measures
4.  Exploring facilitating factors and barriers to the nationwide dissemination of a Dutch school-based obesity prevention program “DOiT”: a study protocol 
BMC Public Health  2013;13:1201.
Background
The evidence-based Dutch Obesity Intervention in Teenagers (DOiT) program is a school-based obesity prevention program for 12 to 14-year olds attending the first two years of prevocational education. This paper describes the study protocol applied to evaluate (a) the nationwide dissemination process of DOiT in the Netherlands, and (b) the relationship between quality of implementation and effectiveness during nationwide dissemination of the program in the Netherlands.
Methods
In order to explore facilitating factors and barriers for dissemination of DOiT, we monitored the process of adoption, implementation and continuation of the DOiT program among 20 prevocational schools in the Netherlands. The study was an observational study using qualitative (i.e. semi-structured interviews) and quantitative methods (i.e. questionnaires and logbooks). Eight process indicators were assessed: recruitment, context, reach, dosage, fidelity, satisfaction, effectiveness and continuation. All teachers, students and parents involved in the implementation of the program were invited to participate in the study. As part of the process evaluation, a cluster-controlled trial with ten control schools was conducted to evaluate the effectiveness of the program on students’ anthropometry and energy balance-related behaviours and its association with quality of implementation.
Discussion
The identified impeding and facilitating factors will contribute to an adjusted strategy promoting adoption, implementation and continuation of the DOiT program to ensure optimal use and, thereby, prevention of obesity in Dutch adolescents.
Trial registration
Current Controlled Trials ISRCTN92755979.
doi:10.1186/1471-2458-13-1201
PMCID: PMC3878240  PMID: 24355056
Dissemination; Implementation; Adolescent; Overweight; Obesity; Schools; Prevention; Process evaluation
5.  What is actually measured in process evaluations for worksite health promotion programs: a systematic review 
BMC Public Health  2013;13:1190.
Background
Numerous worksite health promotion program (WHPPs) have been implemented the past years to improve employees’ health and lifestyle (i.e., physical activity, nutrition, smoking, alcohol use and relaxation). Research primarily focused on the effectiveness of these WHPPs. Whereas process evaluations provide essential information necessary to improve large scale implementation across other settings. Therefore, this review aims to: (1) further our understanding of the quality of process evaluations alongside effect evaluations for WHPPs, (2) identify barriers/facilitators affecting implementation, and (3) explore the relationship between effectiveness and the implementation process.
Methods
Pubmed, EMBASE, PsycINFO, and Cochrane (controlled trials) were searched from 2000 to July 2012 for peer-reviewed (randomized) controlled trials published in English reporting on both the effectiveness and the implementation process of a WHPP focusing on physical activity, smoking cessation, alcohol use, healthy diet and/or relaxation at work, targeting employees aged 18-65 years.
Results
Of the 307 effect evaluations identified, twenty-two (7.2%) published an additional process evaluation and were included in this review. The results showed that eight of those studies based their process evaluation on a theoretical framework. The methodological quality of nine process evaluations was good. The most frequently reported process components were dose delivered and dose received. Over 50 different implementation barriers/facilitators were identified. The most frequently reported facilitator was strong management support. Lack of resources was the most frequently reported barrier. Seven studies examined the link between implementation and effectiveness. In general a positive association was found between fidelity, dose and the primary outcome of the program.
Conclusions
Process evaluations are not systematically performed alongside effectiveness studies for WHPPs. The quality of the process evaluations is mostly poor to average, resulting in a lack of systematically measured barriers/facilitators. The narrow focus on implementation makes it difficult to explore the relationship between effectiveness and implementation. Furthermore, the operationalisation of process components varied between studies, indicating a need for consensus about defining and operationalising process components.
doi:10.1186/1471-2458-13-1190
PMCID: PMC3890539  PMID: 24341605
Implementation; Worksite health promotion program; Systematic review; Process evaluation; Lifestyle intervention; Determinants of implementation; Barriers and facilitators
6.  The incidence of rugby-related catastrophic injuries (including cardiac events) in South Africa from 2008 to 2011: a cohort study 
BMJ Open  2013;3(2):e002475.
Objectives
To establish an accurate and comprehensive injury incidence registry of all rugby union-related catastrophic events in South Africa between 2008 and 2011. An additional aim was to investigate correlates associated with these injuries.
Design
Prospective.
Setting
The South African amateur and professional rugby-playing population.
Participants
An estimated 529 483 Junior and 121 663 Senior rugby union (‘rugby’) players (population at risk).
Outcome measures
Annual average incidences of rugby-related catastrophic injuries by type (cardiac events, traumatic brain and acute spinal cord injuries (ASCIs)) and outcome (full recoveries—fatalities). Playing level (junior and senior levels), position and event (phase of play) were also assessed.
Results
The average annual incidence of ASCIs and Traumatic Brain Injuries combined was 2.00 per 100 000 players (95% CI 0.91 to 3.08) from 2008 to 2011. The incidence of ASCIs with permanent outcomes was significantly higher at the Senior level (4.52 per 100 000 players, 95% CI 0.74 to 8.30) than the Junior level (0.24 per 100 000 players, 95% CI 0 to 0.65) during this period. The hooker position was associated with 46% (n=12 of 26) of all permanent ASCI outcomes, the majority of which (83%) occurred during the scrum phase of play.
Conclusions
The incidence of rugby-related catastrophic injuries in South Africa between 2008 and 2011 is comparable to that of other countries and to most other collision sports. The higher incidence rate of permanent ASCIs at the Senior level could be related to the different law variations or characteristics (eg, less regular training) compared with the Junior level. The hooker and scrum were associated with high proportions of permanent ASCIs. The BokSmart injury prevention programme should focus efforts on these areas (Senior level, hooker and scrum) and use this study as a reference point for the evaluation of the effectiveness of the programme.
doi:10.1136/bmjopen-2012-002475
PMCID: PMC3586133  PMID: 23447464
PREVENTIVE MEDICINE; EPIDEMIOLOGY; SPORTS MEDICINE; AUDIT
7.  Web-based guided self-help for employees with depressive symptoms (Happy@Work): design of a randomized controlled trial 
BMC Psychiatry  2013;13:61.
Background
Depressive disorders are highly prevalent in the working population and are associated with excessive costs for both society and companies. Effective treatment for employees with depressive symptoms in occupational health care is limited. The purpose of this study is to investigate the effectiveness and cost-effectiveness of an indicated preventive web-based guided self-help course for employees with depressive symptoms.
Methods
The study is a two-arm randomized controlled trial comparing a web-based guided self-help course with care-as-usual. The self-help course consists of 6 weekly lessons. Weekly support will be provided by a coach via the website. Subjects in the care-as-usual group do not receive any treatment in addition to regular care. 200 white collar workers from several national and international companies in the Netherlands will be recruited via different methods such as banners on the company’s intranet, pamphlets and posters. Subjects will be included when they: have elevated depressive symptoms (score ≥16 on the Center for Epidemiologic Studies Depression scale), are 18 years of age or older, have access to the Internet and can be contacted via e-mail. Exclusion criteria are: partial or full work absenteeism, a legal labor dispute with the employer and receiving treatment from the company’s occupational health care at study entrance.
The primary outcome is depressive symptoms. Secondary outcomes include work absenteeism, work performance, burnout, anxiety, quality of life, health care use and production losses. Outcome data will be collected at 8 weeks, 6 months, and 12 months after baseline. Analyses will be based on the intention-to-treat principle. The cost-effectiveness analyses will be performed from a societal and a company’s perspective. A process evaluation will be conducted alongside the study.
Discussion
This study evaluates the effectiveness and cost-effectiveness of a web-based guided self-help course for employees with depressive symptoms. This study could stimulate the use of e-mental health interventions in the worksite setting.
Trial registration
Nederlands Trial Register (NTR): TC2993
doi:10.1186/1471-244X-13-61
PMCID: PMC3599070  PMID: 23418886
Internet; Depression; Absenteeism; Employees; Occupational therapy; Self-help; Cognitive therapy; Problem solving; Randomized trial.
8.  Physical and psychosocial benefits of yoga in cancer patients and survivors, a systematic review and meta-analysis of randomized controlled trials 
BMC Cancer  2012;12:559.
Background
This study aimed to systematically review the evidence from randomized controlled trials (RCTs) and to conduct a meta-analysis of the effects of yoga on physical and psychosocial outcomes in cancer patients and survivors.
Methods
A systematic literature search in ten databases was conducted in November 2011. Studies were included if they had an RCT design, focused on cancer patients or survivors, included physical postures in the yoga program, compared yoga with a non-exercise or waitlist control group, and evaluated physical and/or psychosocial outcomes. Two researchers independently rated the quality of the included RCTs, and high quality was defined as >50% of the total possible score. Effect sizes (Cohen’s d) were calculated for outcomes studied in more than three studies among patients with breast cancer using means and standard deviations of post-test scores of the intervention and control groups.
Results
Sixteen publications of 13 RCTs met the inclusion criteria, of which one included patients with lymphomas and the others focused on patients with breast cancer. The median quality score was 67% (range: 22–89%). The included studies evaluated 23 physical and 20 psychosocial outcomes. Of the outcomes studied in more than three studies among patients with breast cancer, we found large reductions in distress, anxiety, and depression (d = −0.69 to −0.75), moderate reductions in fatigue (d = −0.51), moderate increases in general quality of life, emotional function and social function (d = 0.33 to 0.49), and a small increase in functional well-being (d = 0.31). Effects on physical function and sleep were small and not significant.
Conclusion
Yoga appeared to be a feasible intervention and beneficial effects on several physical and psychosocial symptoms were reported. In patients with breast cancer, effect size on functional well-being was small, and they were moderate to large for psychosocial outcomes.
doi:10.1186/1471-2407-12-559
PMCID: PMC3571972  PMID: 23181734
Yoga; Randomized controlled trial; Physical function; Psychosocial function; Quality of life; Cancer
9.  Mediators of the effect of the JUMP-in intervention on physical activity and sedentary behavior in Dutch primary schoolchildren from disadvantaged neighborhoods 
Background
Important health benefits can be achieved when physical activity in children from low socio-economic status is promoted and sedentariness is limited. By specifying the mediating mechanisms of existing interventions one can improve future physical activity interventions. This study explored potential mediators of the long-term effect of the school-based multicomponent JUMP-in intervention on sport participation, outdoor play and screen time in Dutch primary schoolchildren from disadvantaged neighborhoods.
Methods
In total, 600 primary schoolchildren (aged 9.8 ± 0.7, 51% girls, 13% Dutch ethnicity, 35% overweight) from 9 intervention and 10 control schools were included in the analyses. JUMP-in was developed using Intervention Mapping, and targeted psychological and environmental determinants of physical activity. Outcome behaviors were self-reported sport participation, outdoor play, TV-viewing behavior and computer use. Potential mediators were self-reported psychological, social and physical environmental factors.
Results
JUMP-in was effective in improving sport participation after 20 months, but not in improving outdoor play, or reducing TV-viewing or computer time. JUMP-in was not effective in changing hypothesized mediators so no significant mediated effects could be identified. However, changes in self-efficacy, social support and habit strength were positively associated with changes in sport participation, and changes in social support, self-efficacy, perceived planning skills, enjoyment and habit strength were positively associated with changes in outdoor play. Changes in enjoyment was positively associated with changes in TV-viewing while parental rules were negatively associated. Having a computer in the bedroom and enjoyment were positively associated with changes in computer use, while changes in parental rules were negatively associated.
Conclusions
Besides a significant positive effect on sports participation, no significant intervention effect on outdoor play, screen time or any of the potential mediators was found. This suggest that other (unmeasured) factors operated as mediating mechanisms of the intervention, that we used unsuccessful intervention strategies, that the strategies were inappropriately implemented, or that children are unable to accurately recall past activities and cognitions. Additionally, the school setting might not be the sole channel to influence leisure time activities. Still, several personal and environmental constructs were found to be relevant in predicting change in sport participation, outdoor play and screen behavior and seem to be potential mediators. Future interventions are recommended including more effective strategies targeting these relevant constructs, addressing different constructs (e.g. pedagogic skills of parents), and focusing on different implementation settings.
Trail registration
ISRCTN17489378
doi:10.1186/1479-5868-9-131
PMCID: PMC3541111  PMID: 23130806
Mediating; Working mechanisms; Youth; Intervention; Physical activity; Sport; Sedentary; Sitting; Television
10.  Steps that count! : The development of a pedometer-based health promotion intervention in an employed, health insured South African population 
BMC Public Health  2012;12:880.
Background
Physical activity (PA) has been identified as a central component in the promotion of health. PA programs can provide a low cost intervention opportunity, encouraging PA behavioral change while worksites have been shown to be an appropriate setting for implementing such health promotion programs. Along with these trends, there has been an emergence of the use of pedometers as a self-monitoring and motivational aid for PA.
This study determines the effectiveness of a worksite health promotion program comprising of a 10-week, pedometer-based intervention (“Steps that Count!”), and individualized email-based feedback to effect PA behavioral change.
Methods
The study is a randomized controlled trial in a worksite setting, using pedometers and individualized email-based feedback to increase steps per day (steps/d). Participant selection will be based on attendance at a corporate wellness event and information obtained, following the completion of a Health Risk Appraisal (HRA), in keeping with inclusion criteria for the study. All participants will, at week 1 (pre-intervention), be provided with a blinded pedometer to assess baseline levels of PA. Participants will be provided with feedback on pedometer data and identify strategies to improve daily PA towards current PA recommendations. Participants will thereafter be randomly assigned to the intervention group (INT) or control group (CTL). The INT will subsequently wear an un-blinded pedometer for 10 consecutive weeks.
Individualized feedback messages based on average steps per day, derived from pedometer data (INT) and general supportive/motivational messages (INT+CTL), will be provided via bi-weekly e-mails; blinded pedometer-wear will be conducted at week 12 (post-intervention: INT+CTL).
Discussion
The purpose of this paper is to outline the rationale behind, and the development of, an intervention aimed at improving ambulatory PA through pedometer use, combined with regular, individualized, email-based feedback. Pedometer-measured PA and individualized feedback may be a practical and easily applied intervention.
Trial registration
Number: DOH-27-0112-3951
doi:10.1186/1471-2458-12-880
PMCID: PMC3536647  PMID: 23075000
Pedometer; Health risk appraisal; Physical activity; Computer-based feedback
11.  The design of a real-time formative evaluation of the implementation process of lifestyle interventions at two worksites using a 7-step strategy (BRAVO@Work) 
BMC Public Health  2012;12:619.
Background
Worksite health promotion programs (WHPPs) offer an attractive opportunity to improve the lifestyle of employees. Nevertheless, broad scale and successful implementation of WHPPs in daily practice often fails. In the present study, called BRAVO@Work, a 7-step implementation strategy was used to develop, implement and embed a WHPP in two different worksites with a focus on multiple lifestyle interventions.
This article describes the design and framework for the formative evaluation of this 7-step strategy under real-time conditions by an embedded scientist with the purpose to gain insight into whether this this 7-step strategy is a useful and effective implementation strategy. Furthermore, we aim to gain insight into factors that either facilitate or hamper the implementation process, the quality of the implemented lifestyle interventions and the degree of adoption, implementation and continuation of these interventions.
Methods and design
This study is a formative evaluation within two different worksites with an embedded scientist on site to continuously monitor the implementation process. Each worksite (i.e. a University of Applied Sciences and an Academic Hospital) will assign a participating faculty or a department, to implement a WHPP focusing on lifestyle interventions using the 7-step strategy. The primary focus will be to describe the natural course of development, implementation and maintenance of a WHPP by studying [a] the use and adherence to the 7-step strategy, [b] barriers and facilitators that influence the natural course of adoption, implementation and maintenance, and [c] the implementation process of the lifestyle interventions. All data will be collected using qualitative (i.e. real-time monitoring and semi-structured interviews) and quantitative methods (i.e. process evaluation questionnaires) applying data triangulation. Except for the real-time monitoring, the data collection will take place at baseline and after 6, 12 and 18 months.
Discussion
This is one of the few studies to extensively and continuously monitor the natural course of the implementation process of a WHPP by a formative evaluation using a mix of quantitative and qualitative methods on different organizational levels (i.e. management, project group, employees) with an embedded scientist on site.
Trial Registration
NTR2861
doi:10.1186/1471-2458-12-619
PMCID: PMC3490970  PMID: 22871020
Implementation strategy; Process evaluation; Formative evaluation; Qualitative study; Worksite health promotion; Embedded scientist; Data triangulation
12.  The development of the Be Active & Relax “Vitality in Practice” (VIP) project and design of an RCT to reduce the need for recovery in office employees 
BMC Public Health  2012;12:592.
Background
There is strong evidence to suggest that multiple work-related health problems are preceded by a higher need for recovery. Physical activity and relaxation are helpful in decreasing the need for recovery. This article aims to describe (1) the development and (2) the design of the evaluation of a daily physical activity and relaxation intervention to reduce the need for recovery in office employees.
Methods/Design
The study population will consist of employees of a Dutch financial service provider. The intervention was systematically developed, based on parts of the Intervention Mapping (IM) protocol. Assessment of employees needs was done by combining results of face-to-face interviews, a questionnaire and focus group interviews. A set of theoretical methods and practical strategies were selected which resulted in an intervention program consisting of Group Motivational Interviewing (GMI) supported by a social media platform, and environmental modifications. The Be Active & Relax program will be evaluated in a modified 2 X 2 factorial design. The environmental modifications will be pre-stratified and GMI will be randomised on department level. The program will be evaluated, using 4 arms: (1) GMI and environmental modifications; (2) environmental modifications; (3) GMI; (4) no intervention (control group). Questionnaire data on the primary outcome (need for recovery) and secondary outcomes (daily physical activity, sedentary behaviour, relaxation/detachment, work- and health-related factors) will be gathered at baseline (T0), at 6 months (T1), and at 12 months (T2) follow-up. In addition, an economic and a process evaluation will be performed.
Discussion
Reducing the need for recovery is hypothesized to be beneficial for employees, employers and society. It is assumed that there will be a reduction in need for recovery after 6 months and 12 months in the intervention group, compared to the control group. Results are expected in 2013.
Trial registration
Netherlands Trial Register (NTR): NTR2553
doi:10.1186/1471-2458-12-592
PMCID: PMC3487972  PMID: 22852835
Need for recovery; Relaxation; Physical activity; Environmental modifications; Group motivational interviewing; Employees; RCT
13.  No significant improvement of cardiovascular disease risk indicators by a lifestyle intervention in people with Familial Hypercholesterolemia compared to usual care: results of a randomised controlled trial 
BMC Research Notes  2012;5:181.
Background
People with Familial Hypercholesterolemia (FH) may benefit from lifestyle changes supporting their primary treatment of dyslipidaemia. This project evaluated the efficacy of an individualised tailored lifestyle intervention on lipids (low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), total cholesterol (TC) and triglycerides), systolic blood pressure, glucose, body mass index (BMI) and waist circumference in people with FH.
Methods
Adults with FH (n = 340), recruited from a Dutch cascade screening program, were randomly assigned to either a control group or an intervention group. The personalised intervention consisted of web-based tailored lifestyle advice and personal counselling. The control group received care as usual. Lipids, systolic blood pressure, glucose, BMI, and waist circumference were measured at baseline and after 12 months. Regression analyses were conducted to examine differences between both groups.
Results
After 12 months, no significant between-group differences of cardiovascular disease (CVD) risk indicators were observed. LDL-C levels had decreased in both the intervention and control group. This difference between intervention and control group was not statistically significant.
Conclusions
This project suggests that an individually tailored lifestyle intervention did not have an additional effect in improving CVD risk indicators among people with FH. The cumulative effect of many small improvements in all indicators on long term CVD risk remains to be assessed in future studies.
Trial registration
NTR1899 at ww.trialregister.nl
doi:10.1186/1756-0500-5-181
PMCID: PMC3392724  PMID: 22490761
14.  Cost-effectiveness of an exercise program during pregnancy to prevent gestational diabetes: Results of an economic evaluation alongside a randomised controlled trial 
Background
The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide. GDM and the risks associated with GDM lead to increased health care costs and losses in productivity. The objective of this study is to evaluate whether the FitFor2 exercise program during pregnancy is cost-effective from a societal perspective as compared to standard care.
Methods
A randomised controlled trial (RCT) and simultaneous economic evaluation of the FitFor2 program were conducted. Pregnant women at risk for GDM were randomised to an exercise program to prevent high maternal blood glucose (n = 62) or to standard care (n = 59). The exercise program consisted of two sessions of aerobic and strengthening exercises per week. Clinical outcome measures were maternal fasting blood glucose levels, insulin sensitivity and infant birth weight. Quality of life was measured using the EuroQol 5-D and quality-adjusted life-years (QALYs) were calculated. Resource utilization and sick leave data were collected by questionnaires. Data were analysed according to the intention-to-treat principle. Missing data were imputed using multiple imputations. Bootstrapping techniques estimated the uncertainty surrounding the cost differences and incremental cost-effectiveness ratios.
Results
There were no statistically significant differences in any outcome measure. During pregnancy, total health care costs and costs of productivity losses were statistically non-significant (mean difference €1308; 95%CI €-229 - €3204). The cost-effectiveness analyses showed that the exercise program was not cost-effective in comparison to the control group for blood glucose levels, insulin sensitivity, infant birth weight or QALYs.
Conclusion
The twice-weekly exercise program for pregnant women at risk for GDM evaluated in the present study was not cost-effective compared to standard care. Based on these results, implementation of this exercise program for the prevention of GDM cannot be recommended.
Trial registration
NTR1139
doi:10.1186/1471-2393-12-64
PMCID: PMC3475114  PMID: 22762376
Cost-effectiveness; Pregnancy; Exercise
15.  Is the process of delivery of an individually tailored lifestyle intervention associated with improvements in LDL cholesterol and multiple lifestyle behaviours in people with Familial Hypercholesterolemia? 
BMC Public Health  2012;12:348.
Background
More insight in the association between reach, dose and fidelity of intervention components and effects is needed. In the current study, we aimed to evaluate reach, dose and fidelity of an individually tailored lifestyle intervention in people with Familial Hypercholesterolemia (FH) and the association between intervention dose and changes in LDL-Cholesterol (LDL-C), and multiple lifestyle behaviours at 12-months follow-up.
Methods
Participants (n = 181) randomly allocated to the intervention group received the PRO-FIT intervention consisting of computer-tailored lifestyle advice (PRO-FIT*advice) and counselling (face-to-face and telephone booster calls) using Motivational Interviewing (MI). According to a process evaluation plan, intervention reach, dose delivered and received, and MI fidelity were assessed using the recruitment database, website/counselling logs and the Motivational Interviewing Treatment Integrity (MITI 3.1.1.) code. Regression analyses were conducted to explore differences between participant and non-participant characteristics, and the association between intervention dose and change in LDL-C, and multiple lifestyle behaviours.
Results
A 34% (n = 181) representative proportion of the intended intervention group was reached during the recruitment phase; participants did not differ from non-participants (n = 623) on age, gender and LDL-C levels. Of the participants, 95% received a PRO-FIT*advice log on account, of which 49% actually logged on and completed at least one advice module. Nearly all participants received a face-to-face counselling session and on average, 4.2 telephone booster calls were delivered. None of the face-to-face sessions were implemented according to MI guidelines. Overall, weak non-significant positive associations were found between intervention dose and LDL-C and lifestyle behaviours.
Conclusions
Implementation of the PRO-FIT intervention in practice appears feasible, particularly PRO-FIT*advice, since it can be relative easily implemented with a high dose delivered. However, only less than half of the intervention group received the complete intervention-package as intended. Strategies to let participants optimally engage in using web-based computer-tailored interventions like PRO-FIT*advice are needed. Further, more emphasis should be put on more extensive MI training and monitoring/supervision.
Trial registration
NTR1899 at ww.trialregister.nl.
doi:10.1186/1471-2458-12-348
PMCID: PMC3487747  PMID: 22583789
Counselling; Computer tailoring; Cholesterol; Lifestyle behaviours; Dose; Fidelity; Motivational interviewing; Process evaluation; Efficacy
16.  The effectiveness of physical activity monitoring and distance counseling in an occupational setting – Results from a randomized controlled trial (CoAct) 
BMC Public Health  2012;12:344.
Background
Lack of physical activity (PA) is a known risk factor for many health conditions. The workplace is a setting often used to promote activity and health. We investigated the effectiveness of an intervention on PA and productivity-related outcomes in an occupational setting.
Methods
We conducted a randomized controlled trial of 12 months duration with two 1:1 allocated parallel groups of insurance company employees. Eligibility criteria included permanent employment and absence of any condition that risked the participant’s health during PA. Subjects in the intervention group monitored their daily PA with an accelerometer, set goals, had access to an online service to help them track their activity levels, and received counseling via telephone or web messages for 12 months. The control group received the results of a fitness test and an information leaflet on PA at the beginning of the study. The intervention’s aim was to increase PA, improve work productivity, and decrease sickness absence. Primary outcomes were PA (measured as MET minutes per week), work productivity (quantity and quality of work; QQ index), and sickness absence (SA) days at 12 months. Participants were assigned to groups using block randomization with a computer-generated scheme. The study was not blinded.
Results
There were 544 randomized participants, of which 521 were included in the analysis (64% female, mean age 43 years). At 12 months, there was no significant difference in physical activity levels between the intervention group (n = 264) and the control group (n = 257). The adjusted mean difference was −206 MET min/week [95% Bayesian credible interval −540 to 128; negative values favor control group]. There was also no significant difference in the QQ index (−0.5 [−4.4 to 3.3]) or SA days (0.0 [−1.2 to 0.9]). Of secondary outcomes, body weight (0.5 kg [0.0 to 1.0]) and percentage of body fat (0.6% [0.2% to 1.1%]) were slightly higher in the intervention group. An exploratory subgroup analysis revealed no subgroups in which the intervention affected physical activity. No adverse events were reported.
Conclusions
The intervention was not found effective, and this study does not provide support for the effectiveness of the workplace PA intervention used here.
Trial registration
ClinicalTrials.gov identifier: NCT00994565
doi:10.1186/1471-2458-12-344
PMCID: PMC3507818  PMID: 22578104
Physical activity; Health behavior; Physical activity intervention; Lifestyle intervention; Distance counseling; Work productivity; Outcomes; Randomized controlled trial
17.  Associations between Safety from Crime, Cycling, and Obesity in a Dutch Elderly Population: Results from the Longitudinal Aging Study Amsterdam 
The objective of this cross-sectional study was to investigate differences in associations between crime rates, cycling, and weight status between people living in low and high socioeconomic status (SES) neighbourhoods. In total, 470 participants in the Longitudinal Aging Study Amsterdam were included (age: 63–70 y). Body height and weight were measured using a stadiometer and calibrated weight scale, respectively. Cycling behaviour was assessed in a face-to-face interview, and neighbourhood crime rates were assessed using data from police reports. Men residing in high SES neighbourhoods cycled more than males residing in low SES neighbourhoods. Cycling was negatively related to crime rates among both men and women living in low SES neighbourhoods. Among men living in low SES neighbourhoods, more cycling was associated with lower BMI. Interventions aiming to prevent obesity in older people may consider aiming at increasing bicycle use in lower SES neighbourhoods, but neighbourhood safety issues should be considered.
doi:10.1155/2012/127857
PMCID: PMC3317166  PMID: 22523503
18.  Direction of the association between body fatness and self-reported screen time in Dutch adolescents 
Background
Screen time has been associated with pediatric overweight. However, it is unclear whether overweight predicts or is predicted by excessive amounts of screen time. The aim of this study was to examine the direction of the association between screen time and body fatness in Dutch adolescents.
Methods
Longitudinal data of 465 Dutch adolescents (mean age at baseline 13 years, 53% boys) was used. Body fatness (objectively measured BMI, four skin folds and waist- and hip circumference), self-reported time spent watching TV and computer use, and aerobic fitness (shuttle run test) were assessed in all participants at three time points during 12 months. Multi-level linear autoregressive analyses was used to examine whether screen time predicted body fatness in the following time period and whether body fatness predicted screen time. Analyses were performed for boys and girls separately and adjusted for ethnicity and aerobic fitness.
Results
Time spent TV viewing did predict changes in BMI and hip circumference in boys, but not in girls, in the subsequent period. Computer time significantly predicted increases in skinfolds in boys and girls and increases in BMI in girls. Body fatness did not predict any changes in screen time.
Conclusion
The present study only partly supports the widely posited hypothesis that higher levels of screen time cause increases in body fatness. In addition, this study demonstrates that high levels of body fatness do not predict increases in screen time.
doi:10.1186/1479-5868-9-4
PMCID: PMC3398280  PMID: 22273542
Adolescents; body fatness; screen time; causality
19.  Exploratory Study of Web-Based Planning and Mobile Text Reminders in an Overweight Population 
Background
Forming specific health plans can help translate good intentions into action. Mobile text reminders can further enhance the effects of planning on behavior.
Objective
Our aim was to explore the combined impact of a Web-based, fully automated planning tool and mobile text reminders on intention to change saturated fat intake, self-reported saturated fat intake, and portion size changes over 4 weeks.
Methods
Of 1013 men and women recruited online, 858 were randomly allocated to 1 of 3 conditions: a planning tool (PT), combined planning tool and text reminders (PTT), and a control group. All outcome measures were assessed by online self-reports. Analysis of covariance was used to analyze the data.
Results
Participants allocated to the PT (meansat urated fat 3.6, meancopingplanning 3) and PTT (meansaturatedfat 3.5, meancopingplanning 3.1) reported a lower consumption of high-fat foods (F 2,571 = 4.74, P = .009) and higher levels of coping planning (F 2,571 = 7.22, P < .001) than the control group (meansat urated f at 3.9, meancopingplanning 2.8). Participants in the PTT condition also reported smaller portion sizes of high-fat foods (mean 2.8; F 2, 569 = 4.12, P = .0) than the control group (meanportions 3.1). The reduction in portion size was driven primarily by the male participants in the PTT (P = .003). We found no significant group differences in terms of percentage saturated fat intake, intentions, action planning, self-efficacy, or feedback on the intervention.
Conclusions
These findings support the use of Web-based tools and mobile technologies to change dietary behavior. The combination of a fully automated Web-based planning tool with mobile text reminders led to lower self-reported consumption of high-fat foods and greater reductions in portion sizes than in a control condition.
Trial Registration
International Standard Randomized Controlled Trial Number (ISRCTN): 61819220; http://www.controlled-trials.com/ISRCTN61819220 (Archived by WebCite at http://www.webcitation.org/63YiSy6R8)
doi:10.2196/jmir.1773
PMCID: PMC3278104  PMID: 22182483
Implementation intentions; mobile text reminders; saturated fat
20.  Web-Based Risk Communication and Planning in an Obese Population: Exploratory Study 
Background
A healthy diet, low in saturated fat and high in fiber, is a popular medical recommendation in preventing cardiovascular disease (CVD). One approach to motivating healthier eating is to raise individuals’ awareness of their CVD risk and then help them form specific plans to change.
Objectives
The aim was to explore the combined impact of a Web-based CVD risk message and a fully automated planning tool on risk perceptions, intentions, and saturated fat intake changes over 4 weeks.
Methods
Of the 1187 men and women recruited online, 781 were randomly allocated to one of four conditions: a CVD risk message, the same CVD risk message paired with planning, planning on its own, and a control group. All outcome measures were assessed by online self-reports. Generalized linear modeling was used to analyze the data.
Results
Self-perceived consumption of low saturated fat foods (odds ratio 11.40, 95% CI 1.86–69.68) and intentions to change diet (odds ratio 21.20, 95% CI 2.6–172.4) increased more in participants allocated to the planning than the control group. No difference was observed between the four conditions with regard to percentage saturated fat intake changes. Contrary to our expectations, there was no difference in perceived and percentage saturated fat intake change between the CVD risk message plus planning group and the control group. Risk perceptions among those receiving the CVD risk message changed to be more in line with their age (change in slopeindividual = 0.075, P = .01; change in slopecomparative = 0.100, P = .001), whereas there was no change among those who did not receive the CVD risk message.
Conclusion
There was no evidence that combining a CVD risk message with a planning tool reduces saturated fat intake more than either alone. Further research is required to identify ways in which matching motivational and volitional strategies can lead to greater behavior changes.
Trial Registration
International Standard Randomized Controlled Trial Number (ISRCTN): 91154001; http://www.controlled-trials.com/ISRCTN91154001 (Archived by WebCite at http://www.webcitation.org/62sBoGeOO)
doi:10.2196/jmir.1579
PMCID: PMC3278086  PMID: 22126827
Risk perceptions; cardiovascular disease; planning; saturated fat intake
21.  Short and long term effects of a lifestyle intervention for construction workers at risk for cardiovascular disease: a randomized controlled trial 
BMC Public Health  2011;11:836.
Background
The prevalence of overweight and elevated cardiovascular disease (CVD) risk among workers in the construction industry is relatively high. Improving lifestyle lowers CVD risk and may have work-related benefits. The purpose of the study was to evaluate the effects on physical activity (PA), diet, and smoking of a lifestyle intervention consisting of individual counseling among male workers in the construction industry with an elevated risk of cardiovascular disease (CVD).
Methods
In a randomized controlled trial including 816 male blue- and white-collar workers in the construction industry with an elevated risk of CVD, usual care was compared to a 6-month lifestyle intervention. The intervention consisted of individual counseling using motivational interviewing techniques, and was delivered by an occupational physician or occupational nurse. In three face to face and four telephone contacts, the participant's risk profile, personal determinants, and barriers for behavior change were discussed, and personal goals were set. Participants chose to aim at either diet and PA, or smoking. Data were collected at baseline and after six and 12 months, by means of a questionnaire. To analyse the data, linear and logistic regression analyses were performed.
Results
The intervention had a statistically significant beneficial effect on snack intake (β-1.9, 95%CI -3.7; -0.02) and fruit intake (β 1.7, 95%CI 0.6; 2.9) at 6 months. The effect on snack intake was sustained until 12 months; 6 months after the intervention had ended (β -1.9, 95%CI -3.6; -0.2). The intervention effects on leisure time PA and metabolic equivalent-minutes were not statistically significant. The beneficial effect on smoking was statistically significant at 6 (OR smoking 0.3, 95%CI 0.1;0.7), but not at 12 months (OR 0.8, 95%CI 0.4; 1.6).
Conclusions
Beneficial effects on smoking, fruit, and snack intake can be achieved by an individual-based lifestyle intervention among male construction workers with an elevated risk of CVD. Future research should be done on strategies to improve leisure time PA and on determinants of maintenance of changed behavior. Considering the rising prevalence of unhealthy lifestyle and CVD, especially in the aging population, implementation of this intervention in the occupational health care setting is recommended.
Trial registration
Current Controlled Trials ISRCTN60545588
doi:10.1186/1471-2458-11-836
PMCID: PMC3247875  PMID: 22040007
22.  For whom and under what circumstances do school-based energy balance behavior interventions work? Systematic review on moderators 
The aim of this review was to systematically review the results and quality of studies investigating the moderators of school-based interventions aimed at energy balance-related behaviors. We systematically searched the electronic databases of Pubmed, EMBASE, Cochrane, PsycInfo, ERIC and Sportdiscus. In total 61 articles were included. Gender, ethnicity, age, baseline values of outcomes, initial weight status and socioeconomic status were the most frequently studied potential moderators. The moderator with the most convincing evidence was gender. School-based interventions appear to work better for girls than for boys. Due to the inconsistent results, many studies reporting non-significant moderating effects, and the moderate methodological quality of most studies, no further consistent results were found. Consequently, there is lack of insight into what interventions work for whom. Future studies should apply stronger methodology to test moderating effects of important potential target group segmentations.
doi:10.3109/17477166.2011.566440
PMCID: PMC3190836  PMID: 21651421
Children; diet; intervention; moderator; overweight; physical activity
23.  Adolescent predictors of objectively measured physical activity and sedentary behaviour at age 42: the Amsterdam Growth and Health Longitudinal Study (AGAHLS) 
Background
This study investigated the associations of physical characteristics and personality in adolescence with physical activity and sedentary behaviour in adulthood.
Findings
Physical characteristics (i.e. objectively measured BMI, sum of skin folds, MOPER test battery performance), and personality (i.e. self-reported inadequacy, social inadequacy, rigidity, self-sufficiency/recalcitrance, dominance, achievement motivation, facilitating anxiety, debilitating anxiety, and social desirability) were assessed in 217 adolescent boys (Mean 13.0, SD 0.6) and girls (Mean 12.9, SD 0.6). Twenty-nine years later, at the age of 42, their physical activity and sedentary behaviour were assessed by means of accelerometry. Boys who scored lower on self-sufficiency/recalcitrance and higher on facilitating anxiety spent more time sedentary in adulthood. Girls with a superior standing high jump performance, and a lower score on social desirability spent more time sedentary in adulthood. In contrast with sedentary behaviour, physical activity at age 42 year could not be predicted by physical characteristics or personality in adolescence.
Conclusions
Sedentary behaviour in adulthood was partly explained by physical characteristics and/or personality in adolescence. Thus, our results suggest that it may be possible to identify people who are at risk of becoming sedentary at a rather young age.
doi:10.1186/1479-5868-8-107
PMCID: PMC3198875  PMID: 21961795
Accelerometry; Aerobic fitness; Longitudinal; Motor fitness; Personality
24.  Ankles back in randomized controlled trial (ABrCt): braces versus neuromuscular exercises for the secondary prevention of ankle sprains. Design of a randomised controlled trial 
Background
Ankle sprains are the most common sports and physical activity related injury. There is extensive evidence that there is a twofold increased risk for injury recurrence for at least one year post injury. In up to 50% of all cases recurrences result in disability and lead to chronic pain or instability, requiring prolonged medical care. Therefore ankle sprain recurrence prevention in athletes is essential. This RCT evaluates the effect of the combined use of braces and neuromuscular training (e.g. proprioceptive training/sensorimotor training/balance training) against the individual use of either braces or neuromuscular training alone on ankle sprain recurrences, when applied to individual athletes after usual care.
Methods/Design
This study was designed as three way randomized controlled trial with one year follow-up. Healthy individuals between 12 and 70 years of age, who were actively participating in sports and who had sustained a lateral ankle sprain in the two months prior to inclusion, were eligible for inclusion. After subjects had finished ankle sprain treatment by means of usual care, they were randomised to any of the three study groups. Subjects in group 1 received an eight week neuromuscular training program, subjects in group 2 received a sports brace to be worn during all sports activities for the duration of one year, and group 3 received a combination of the neuromuscular training program and a sports brace to be worn during all sports activities for the duration of eight weeks. Outcomes were assessed at baseline and every month for 12 months therafter. The primary outcome measure was incidence of ankle sprain recurrences. Secondary outcome measures included the direct and indirect costs of recurrent injury, the severity of recurrent injury, and the residual complaints during and after the intervention.
Discussion
The ABrCt is the first randomized controlled trial to directly compare the secondary preventive effect of the combined use of braces and neuromuscular training, against the use of either braces or neuromuscular training as separate secondary preventive measures. This study expects to identify the most effective and cost-efficient secondary preventive measure for ankle sprains. The study results could lead to changes in the clinical guidelines on the prevention of ankle sprains, and they will become available in 2012.
Trial registration
Netherlands Trial Register (NTR): NTR2157
doi:10.1186/1471-2474-12-210
PMCID: PMC3195211  PMID: 21951559
25.  Determinants of the intention for using a lumbar support among home care workers with recurrent low back pain 
European Spine Journal  2010;19(9):1502-1507.
In most effectiveness studies on lumbar supports for patients with low back pain, insufficient data are reported about adherence. In a secondary preventive RCT, we found beneficial effects and a good adherence among home care workers with low back pain. To target the use of lumbar supports on those patients who can benefit optimally from usage, we need to know why people are adherent. We used the attitude, social support and self-efficacy model to identify determinants for prolonged adherence to wearing a lumbar support. The strongest predictor for intending sustained use of a lumbar support was a positive attitude towards lumbar supports, explaining 41% of the variance (B = 1.31; p < 0.001). Social support and self-efficacy played a minor role. The intention for prolonged use of a lumbar support for workers with recurrent back pain was mainly explained by a positive attitude. The discomfort of a lumbar support was outweighed by perceived benefit.
Electronic supplementary material
The online version of this article (doi:10.1007/s00586-010-1399-5) contains supplementary material, which is available to authorized users.
doi:10.1007/s00586-010-1399-5
PMCID: PMC2989292  PMID: 20490876
Low back pain; Lumbar supports; Behaviour; Adherence; ASE-model

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