Towards OPtimal TIming and Method for promoting sUstained adherence to lifestyle and body weight recommendations in postMenopausal breast cancer survivors (the OPTIMUM-study): protocol for a longitudinal mixed-method study.

BACKGROUND: The majority of postmenopausal breast cancer (PMBC) survivors do not adhere to lifestyle recommendations and have excess body weight. In this group, this is associated with poorer health-related quality of life and an increased risk of type II diabetes mellitus, cardiovascular disease, second primary cancers, cancer recurrences, and mortality. Gaining and maintaining a healthy lifestyle and body composition is therefore important. It is unknown when and how sustained adherence to these recommendations can be promoted optimally in PMBC survivors. Therefore, the OPTIMUM study aims to identify the optimal timing and method for promoting sustained adherence to lifestyle and body weight recommendations in PMBC survivors. METHODS: The OPTIMUM-study has a mixed-methods design. To assess optimal timing, a longitudinal observational study will be conducted among approximately 1000 PMBC survivors. The primary outcomes are adherence to lifestyle and body weight recommendations, readiness for change, and need for support. Questionnaires will be administered at 4-6 months after cancer diagnosis (wave 1: during treatment and retrospectively before diagnosis), 1 year after diagnosis (wave 2: after completion of initial treatment), and 1.5 years after diagnosis (wave 3: during follow-up). Wave 2 and 3 include blood sampling, and either wearing an accelerometer for 7 days or completing a 3-day online food diary (randomly assigned at hospital level). To assess the optimal method, behavioural determinants of the primary outcomes will be matched with Behavior Change Techniques using the Behaviour Change Technique Taxonomy. Qualitative research methods will be used to explore perceptions, needs and preferences of PMBC survivors (semi-structured interviews, focus groups) and health care providers (Delphi study). Topics include perceptions on optimal timing to promote adherence; facilitators and motivators of, and barriers towards (sustained) adherence to recommendations; and acceptability of the selected methods. DISCUSSION: The OPTIMUM study aims to gain scientific knowledge on when and how to promote sustained adherence to lifestyle and body weight recommendations among PBMC survivors. This knowledge can be incorporated into guidelines for tailored promotion in clinical practice to improve health outcomes.

Effect of diet with or without exercise on abdominal fat in postmenopausal women - a randomised trial.

BACKGROUND: We assessed the effect of equivalent weight loss with or without exercise on (intra-) abdominal fat in postmenopausal women in the SHAPE-2 study. METHODS: The SHAPE-2 study is a three-armed randomised controlled trial conducted in 2012-2013 in the Netherlands. Postmenopausal overweight women were randomized to a diet (n = 97), exercise plus diet (n = 98) or control group (n = 48). Both intervention groups aimed for equivalent weight loss (6-7%) following a calorie-restricted diet (diet group) or a partly supervised intensive exercise programme (4 h per week) combined with a small caloric restriction (exercise plus diet group). Outcomes after 16 weeks are amount and distribution of abdominal fat, measured by magnetic resonance imaging (MRI) with the use of the three-point IDEAL Dixon method. RESULTS: The diet and exercise plus diet group lost 6.1 and 6.9% body weight, respectively. Compared to controls, subcutaneous and intra-abdominal fat reduced significantly with both diet (- 12.5% and - 12.0%) and exercise plus diet (- 16.0% and - 14.6%). Direct comparison between both interventions revealed that the reduction in subcutaneous fat was statistically significantly larger in the group that combined exercise with diet: an additional 10.6 cm2 (95%CI -18.7; - 2.4) was lost compared to the diet-only group. Intra-abdominal fat loss was not significantly larger in the exercise plus diet group (- 3.8 cm2, 95%CI -9.0; 1.3). CONCLUSIONS: We conclude that weight loss of 6-7% with diet or with exercise plus diet reduced both subcutaneous and intra-abdominal fat. Only subcutaneous fat statistically significantly reduced to a larger extent when exercise is combined with a small caloric restriction. TRIAL REGISTER: NCT01511276 (clinicaltrials.gov), prospectively registered.

Manifestations of integrated public health policy in Dutch municipalities.

Integrated public health policy (IPHP) aims at integrating health considerations into policies of other sectors. Since the limited empirical evidence available may hamper its further development, we systematically analysed empirical manifestations of IPHP, by placing policy strategies along a continuum of less-to-more policy integration, going from intersectoral action (IA) to healthy public policy (HPP) to health in all policies (HiAP). Our case study included 34 municipal projects of the Dutch Gezonde Slagkracht Programme (2009-15), which supports the development and implementation of IPHP on overweight, alcohol and drug abuse, and smoking. Our content analysis of project application forms and interviews with all project leaders used a framework approach involving the policy strategies and the following policy variables: initiator, actors, policy goals, determinants and policy instruments. Most projects showed a combination of policy strategies. However, manifestations of IPHP in overweight projects predominantly involved IA. More policy integration was apparent in alcohol/drugs projects (HPP) and in all-theme projects (HiAP). More policy integration was related to broad goal definitions, which allowed for the involvement of actors representing several policy sectors. This enabled the implementation of a mix of policy instruments. Determinants of health were not explicitly used as a starting point of the policy process. If a policy problem justifies policy integration beyond IA, it might be helpful to start from the determinants of health (epidemiological reality), systematically transform them into policy (policy reality) and set broad policy goals, since this gives actors from other sectors the opportunity to participate.

Intersectoral Cooperation in 12 European Case Studies Aiming for Better Health, Environmental Sustainability, and Health Equity: Protocol for a Qualitative Evaluation.

BACKGROUND: The INHERIT (INtersectoral Health and Environment Research for InnovaTion) project has evaluated intersectoral cooperation (IC) in 12 European case studies attempting to promote health, environmental sustainability, and equity through behavior and lifestyle changes. These factors are the concerns of multiple sectors of government and society. Cooperation of health and environmental sectors with other sectors is needed to enable effective action. IC is thus essential to promote a triple win of health, sustainability, and equity. OBJECTIVE: This paper describes the design of a qualitative study to gain insights into successful organization of IC, facilitators and barriers, and how future steps can be taken to improve IC in the evaluated case studies. METHODS: Each case study was assessed qualitatively through a focus group. A total of 12 focus groups in 10 different European countries with stakeholders, implementers, policymakers, and/or citizens were held between October 2018 and March 2019. Five to eight participants attended each focus group. The focus group method was based on appreciative inquiry, which is an asset-based approach focusing on what works well, why it is working well, and how to strengthen assets in the future. A stepped approach was used, with central coordination and analysis, and local implementation and reporting. Local teams were trained to apply a common protocol using a webinar and handbook on organizing, conducting, and reporting focus groups. Data were gathered in each country in the local language. Translated data were analyzed centrally using deductive thematic analysis, with consideration of further emerging themes. Analyses involved the capability, opportunity, motivation-behavior (COM-b) system to categorize facilitators and barriers into capability, motivation, or opportunity-related themes, as these factors influence the behaviors of individuals and groups. Web-based review sessions with representatives from all local research teams were held to check data analysis results and evaluate the stepped approach. RESULTS: Data collection has been completed. A total of 76 individuals participated in 12 focus groups. In December 2019, data analysis was nearly complete, and the results are expected to be published in fall 2020. CONCLUSIONS: This study proposes a stepped approach that allows cross-country focus group research using a strict protocol while dealing with language and cultural differences. The study generates insights into IC processes and facilitators in different countries and case studies to filter out which facilitators are essential to include. Simultaneously, the approach can strengthen cooperation among stakeholders by looking at future cooperation possibilities. By providing knowledge on how to plan for, improve, and sustain IC successfully to deal with today's multisectoral challenges, this study can contribute to better intersectoral action for the triple win of better health, sustainability, and equity. This protocol can serve as a tool for other researchers who plan to conduct cross-country qualitative research. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/17323.

Chronically ill patients' preferences for a financial incentive in a lifestyle intervention. Results of a discrete choice experiment.

BACKGROUND: The preferences of diabetes type 2 patients and cardiovascular disease patients for a financial incentive added to a specified combined lifestyle intervention were investigated. METHODS: A discrete choice experiment questionnaire was filled out by 290 diabetes type 2 patients (response rate 29.9%). Panel-mixed-logit models were used to estimate the preferences for a financial incentive. Potential uptake rates of different financial incentives and relative importance scores of the included attributes were estimated. Included attributes and levels were: form of the incentive (cash money and different types of vouchers), value of the incentive (ranging from 15 to 100 euros), moment the incentive is received (start, halfway, after finishing the intervention) and prerequisite for receiving the incentive (registration, attendance or results at group or individual level). RESULTS: Prerequisites for receiving the financial incentive were the most important attribute, according to the respondents. Potential uptake rates for different financial incentives ranged between 37.9% and 58.8%. The latter uptake rate was associated with a financial incentive consisting of cash money with a value of €100 that is handed out after completing the lifestyle program with the prerequisite that the participant attended at least 75% of the scheduled meetings. CONCLUSIONS: The potential uptake of the different financial incentives varied between 37.9% and 58.8%. The value of the incentive does not significantly influence the potential uptake. However, the potential uptake and associated potential effect of the financial incentive is influenced by the type of financial incentive. The preferred type of incentive is €100 in cash money, awarded after completing the lifestyle program if the participant attended at least 75% of the scheduled meetings.

The INHERIT Model: A Tool to Jointly Improve Health, Environmental Sustainability and Health Equity through Behavior and Lifestyle Change.

The need for analysis and action across the interrelated domains of human behaviors and lifestyles, environmental sustainability, health and inequality is increasingly apparent. Currently, these areas are often not considered in conjunction when developing policies or interventions, introducing the potential for suboptimal or conflicting outcomes. The INHERIT model has been developed within the EU-funded project INHERIT as a tool to guide thinking and intersectoral action towards changing the behaviors and lifestyles that play such an important role in today’s multidisciplinary challenges. The model integrates ecological public health and behavioral change models, emphasizing inequalities and those parts of the causal process that are influenced by human behaviors and lifestyles. The model was developed through web-based and live discussions with experts and policy stakeholders. To test the model’s usability, the model was applied to aspects of food consumption. This paper shows that the INHERIT model can serve as a tool to identify opportunities for change in important −food-related behaviors and lifestyles and to examine how they impact on health, health inequalities, and the environment in Europe and beyond. The INHERIT model helps clarify these interrelated domains, creating new opportunities to improve environmental health and health inequality, while taking our planetary boundaries into consideration.

Association between changes in fat distribution and biomarkers for breast cancer.

We assessed the associations between changes in total and abdominal fat and changes in biomarkers for breast cancer risk using data of the SHAPE-2 trial. In the SHAPE-2 trial, 243 postmenopausal overweight women were included. The intervention in this trial consisted of 5-6 kg weight loss either by diet only or exercise plus diet. After 16 weeks, we measured serum sex hormones, inflammatory markers, total body fat (measured by DEXA scan) and intra and subcutaneous abdominal fat (measured by MRI). Associations between changes in different body fat depots and biomarkers were analysed by linear regression using the study cohort irrespective of randomisation to make maximal use of the distribution of changes in fat measures. We found that a loss in total body fat was associated with favourable changes in free oestradiol, free testosterone, leptin and sex hormone binding globulin (SHBG). The loss of intra-abdominal fat was associated with a decrease in free testosterone, hsCRP and leptin, and an increase in SHBG. In the multivariable analysis, the best fitted models for the biomarkers free oestradiol, SHBG leptin and adiponectin included only total body fat. For free testosterone, this was subcutaneous abdominal fat, and for hsCRP and IL-6, only intra-abdominal fat change was important. For IL-6 and adiponectin, however, associations were weak and not significant. We conclude that, in our population of healthy overweight postmenopausal women, loss of fat at different body locations was associated with changes in different types of biomarkers, known to be related to risk of breast cancer.

Health in All Policies? The case of policies to promote bicycle use in the Netherlands.

To gather insight on how Health in All Policies (HiAP) is applied in practice, we carried out a case study on transport policies intended to stimulate a shift from car use to bicycling. We reviewed 3 years (2010, 2011, and 2012) of national budgets and policy documents in the Netherlands, followed by two focus group sessions and a second round of document analysis. We found to our surprise, given the country's history of bicycle promotion, that no HiAP approaches for bicycle promotion remain in place in national transport policies. The Netherlands may face serious challenges in the near future for facilitating bicycle use. Inclusion of health goals requires that the health sector work towards acquiring a better understanding of core values in other sector's policies.

How combined trip purposes are associated with transport choice for short distance trips. Results from a cross-sectional study in the Netherlands.

BACKGROUND: One way to increase physical activity is to stimulate a shift from car use to walking or cycling. In single-purpose trips, purpose was found to be an important predictor of transport choice. However, as far as known, no studies have been conducted to see how trips with combined purposes affect this decision. This study was designed to provide insight into associations between combined purposes and transport choice. METHODS: An online questionnaire (N = 3,663) was used to collect data concerning transport choice for four primary purposes: shopping, going to public natural spaces, sports, and commuting. Per combination of primary trip purpose and transport choice, participants were asked to give examples of secondary purposes that they combine with the primary purpose. Logistic regression analyses were used to model the odds of both cycling and walking versus car use. RESULTS: Primary trip purposes combined with commuting, shopping, visiting private contacts or medical care were more likely to be made by car than by cycling or walking. Combinations with visiting catering facilities, trips to social infrastructure facilities, recreational outings, trips to facilities for the provision of daily requirements or private contacts during the trip were more likely to be made by walking and/or cycling than by car. CONCLUSION: Combined trip purposes were found to be associated with transport choice. When stimulating active transport focus should be on the combined-trip purposes which were more likely to be made by car, namely trips combined with commuting, other shopping, visiting private contacts or medical care.

Design of CIAO, a research program to support the development of an integrated approach to prevent overweight and obesity in the Netherlands.

BACKGROUND: The aim of this paper is to describe the research aims, concepts and methods of the research Consortium Integrated Approach of Overweight (CIAO). CIAO is a concerted action of five Academic Collaborative Centres, local collaborations between academic institutions, regional public health services, local authorities and other relevant sectors in the Netherlands. Prior research revealed lacunas in knowledge of and skills related to five elements of the integrated approach of overweight prevention in children (based upon the French EPODE approach), namely political support, parental education, implementation, social marketing and evaluation. CIAO aims to gain theoretical and practical insight of these elements through five sub-studies and to develop, based on these data, a framework for monitoring and evaluation. METHODS/DESIGN: For this research program, mixed methods are used in all the five sub-studies. First, problem specification through literature research and consultation of stakeholders, experts, health promotion specialists, parents and policy makers will be carried out. Based on this information, models, theoretical frameworks and practical instruments will be developed, tested and evaluated in the communities that implement the integrated approach to prevent overweight in children. Knowledge obtained from these studies and insights from experts and stakeholders will be combined to create an evaluation framework to evaluate the integrated approach at central, local and individual levels that will be applicable to daily practice. DISCUSSION: This innovative research program stimulates sub-studies to collaborate with local stakeholders and to share and integrate their knowledge, methodology and results. Therefore, the output of this program (both knowledge and practical tools) will be matched and form building blocks of a blueprint for a local evidence- and practice-based integrated approach towards prevention of overweight in children. The output will then support various communities to further optimize the implementation and subsequently the effects of this approach.

Personal and environmental characteristics associated with choice of active transport modes versus car use for different trip purposes of trips up to 7.5 kilometers in The Netherlands.

INTRODUCTION: This explorative study examines personal and neighbourhood characteristics associated with short-distance trips made by car, bicycle or walking in order to identify target groups for future interventions. METHODS: Data were derived from 'Mobility Research Netherlands (2004-2009; MON)', a dataset including information regarding trips made by household members (n = ±53,000 respondents annually). Using postal codes of household addresses, MON data were enriched with data on neighbourhood typologies. Multilevel logistic modelling was used to calculate odds ratio (OR) of active transport versus car use associated with four different trip purposes (shopping (reference), commuting, taking or bringing persons or sports). A total of 277,292 short distance trips made by 102,885 persons were included in analyses. RESULTS: Compared to women shopping, women less often take active transport to sports clubs (OR = 0.88) and men less often take active transport for shopping (OR = 0.92), or for bringing or taking persons (OR = 0.76). Those aged 25-34 years (OR = 0.83) and 35-44 years (OR = 0.96) were more likely to use active transport for taking or bringing persons than persons belonging to the other age groups (relative to trips made for shopping by those 65 years or over). A higher use of active transport modes by persons with an university or college degree was found and particularly persons living in urban-centre neighbourhoods were likely to use active transport modes. CONCLUSION: IN DEVELOPING POLICIES PROMOTING A MODE SHIFT SPECIAL ATTENTION SHOULD BE GIVEN TO THE FOLLOWING GROUPS: a) men making short distance trips for taking or bringing persons, b) women making short distance trips to sport facilities, c) persons belonging to the age groups of 25-44 years of age, d) Persons with a primary school or lower general secondary education degree and persons with a high school or secondary school degree and e) persons living in rural or urban-green neighbourhoods.

Practitioner opinions on health promotion interventions that work: opening the 'black box' of a linear evidence-based approach.

While attempts are being made to improve health promotion by following a linear Evidence-Based (EB) approach, the actors involved are aware that the quality of health promotion is not just a matter of supplying 'evidence-based' interventions to local practitioners, but the result of a situated coproduction process that depends on many factors. This paper explores what constitutes an intervention that works from the perspective of health promotion professionals (HPP), and how, according to them, the development and implementation of interventions should be improved. We interviewed 81 HPPs about the use of 10 health promotion interventions at 30 Municipality Health Services in The Netherlands. The HPPs described an intervention that works as something that produces its intended effects after being realized in a local situation. Interventions are realized by combining elements of a supplied intervention (e.g. a theory, artefacts) with elements that are situated in the local context (e.g. funding, local network). Interventions that are transferred contain implicit assumptions about local contexts, but it is often unclear what precisely constitutes an intervention and what is assumed of local contexts. An intervention that works is a situated configuration of aligned elements. A linear EB approach depends on the realization of the local circumstances in which 'evidence based' interventions can work. Various strategies are possible for approximating such circumstances, but the core assumption that the configuration that is realized in practice is similar to the 'evidence based' intervention seems unrealistic for most health promotion in The Netherlands. Under such circumstances, attention should shift from central quality assurance to the system of actors and the distributed actions and heterogeneous learning processes that together add up to interventions that work.

The costs, effects and cost-effectiveness of counteracting overweight on a population level. A scientific base for policy targets for the Dutch national plan for action.

OBJECTIVES: To gain insight in realistic policy targets for overweight at a population level and the accompanying costs. Therefore, the effect on overweight prevalence was estimated of large scale implementation of a community intervention (applied to 90% of general population) and an intensive lifestyle program (applied to 10% of overweight adults), and costs and cost-effectiveness were assessed. METHODS: Costs and effects were based on two Dutch projects and verified by similar international projects. A markov-type simulation model estimated long-term health benefits, health care costs and cost-effectiveness. RESULTS: Combined implementation of the interventions--at the above mentioned scale--reduces prevalence rates of overweight by approximately 3 percentage points and of physical inactivity by 2 percentage points after 5 years, at a cost of 7 euros per adult capita per year. The cost-effectiveness ratio of combined implementation amounts to euro 6000 per life-year gained and euro 5700 per QALY gained (including costs of unrelated diseases in life years gained). Sensitivity analyses showed that these ratios are quite robust. CONCLUSIONS: A realistic policy target is a decrease in overweight prevalence of three percentage points, compared to a situation with no interventions. In reality, large scale implementation of the interventions may not counteract the expected upward trends in The Netherlands completely. Nonetheless, implementation of the interventions is cost-effective.

Validity and repeatability of a simple index derived from the short physical activity questionnaire used in the European Prospective Investigation into Cancer and Nutrition (EPIC) study.

OBJECTIVE: To assess the validity and repeatability of a simple index designed to rank participants according to their energy expenditure estimated by self-report, by comparison with objectively measured energy expenditure assessed by heart-rate monitoring with individual calibration. DESIGN: Energy expenditure was assessed over one year by four separate episodes of 4-day heart-rate monitoring, a method previously validated against whole-body calorimetry and doubly labelled water. Cardio-respiratory fitness was assessed by four repeated measures of sub-maximum oxygen uptake. At the end of the 12-month period, participants completed a physical activity questionnaire that assessed past-year activity. A simple four-level physical activity index was derived by combining occupational physical activity together with time participating in cycling and other physical exercise (such as keep fit, aerobics, swimming and jogging). SUBJECTS: One hundred and seventy-three randomly selected men and women aged 40 to 65 years. RESULTS: The repeatability of the physical activity index was high (weighted kappa=0.6, ). There were positive associations between the physical activity index from the questionnaire and the objective measures of the ratio of daytime energy expenditure to resting metabolic rate and cardio-respiratory fitness As an indirect test of validity, there was a positive association between the physical activity index and the ratio of energy intake, assessed by 7-day food diaries, to predicted basal metabolic rate. CONCLUSIONS: The summary index of physical activity derived from the questions used in the European Prospective Investigation into Cancer and Nutrition (EPIC) study suggest it is useful for ranking participants in terms of their physical activity in large epidemiological studies. The index is simple and easy to comprehend, which may make it suitable for situations that require a concise, global index of activity.