A counselling intervention for individual strategies to prevent complications and strengthen resources during pregnancy in gynaecological care (AOK-Family +): study protocol for a cluster-randomised controlled trial.

BACKGROUND: Lifestyle-related risk factors can increase complications during pregnancy and negatively impact the health of a mother and her child. Knowledge about these compliances among many pregnant women and women of childbearing age is lacking. In the study AOK-Family + , we propose the evaluation of a newly developed counselling intervention. The intervention aims to raise awareness and to provide relevant information about the impact of lifestyle-related risk factors during pregnancy. The aim of the proposed study is to evaluate the effect of this counselling intervention on women's knowledge of lifestyle-related risk factors during pregnancy and the concomitant healthy behaviours. METHODS: A cluster-randomised trial with three arms in Baden-Wuerttemberg, Germany, is proposed. Pregnant women and women of childbearing age will be allocated to one of three groups: online intervention, on-site intervention, or a waiting-list control. Trained counsellors from AOK Baden-Wuerttemberg, a German statutory health insurer, will conduct the counselling sessions. Data collection is conducted throughout validated questionnaires administered at three intervals: before counselling (t0), directly after counselling (t1), and at a 6-week follow-up (t2). The primary outcomes will be health knowledge and healthy behaviours relating to LRFFs during pregnancy. A process evaluation will examine the processes, used resources, and future implementations through additional quantitative questions and qualitative interviews and focus groups. DISCUSSION: Based on this study, an implementation strategy for future conduction of lifestyle consultation during pregnancy could be developed with the aim of reducing pre- and post-mortem mobility and mortality. TRIAL REGISTRATION: The German Clinical Trials Register DRKS00027804. Registered on 2022/01/12.

Health Education about Lifestyle-Related Risk Factors in Gynecological and Obstetric Care: A Qualitative Study of Healthcare Providers' Views in Germany.

OBJECTIVE: Lifestyle-related risk factors (LRRFs) during pregnancy and lactation are associated with a range of health problems. However, previous studies have shown a large knowledge gap among pregnant women regarding the effects of LRRFs. This study aimed to investigate the role of health education about LRRFs during pregnancy and lactation in gynecological and obstetric care from healthcare providers' (HCPs) point of view. METHODS: To explore the views of healthcare providers, a qualitative study was performed. In 2019, 22 in-depth interviews were conducted with a purposive sample of 9 gynecologists and 13 midwives. Participants came from different inpatient and outpatient care settings and from rural, urban, and socially deprived areas in southern Germany. All the interviews were tape-recorded and transcribed verbatim. A combined inductive and deductive approach was applied for data analysis. RESULTS: Interviews with HCPs showed that they were aware of the possible impacts of LRRFs during pregnancy and lactation. They noted the importance of action, specifically among women with low socioeconomic status (SES), migrants, and women with a concerning medical history or other specific needs. However, the interviews showed that, at present, there is no standardized practice of educating patients on LRRFs in routine care. This was attributed to a lack of guidelines and time, unfavorable regulations, and undefined responsibilities. The priority of health education is lower in inpatient healthcare settings as compared to outpatient healthcare settings. HCPs apply a demand-driven healthcare approach, focusing on a woman's medical history, needs, and personal circumstances. HCPs voiced the importance of implementing pre-conception education across different healthcare settings, garnering support from other health organizations, and setting out clearly defined responsibilities among HCPs. CONCLUSIONS: This qualitative study explored HCPs' perspectives on health education about LRRFs during pregnancy and lactation. The results from this study emphasize the need for a central strategy for health education about LRRFs during pregnancy and lactation in gynecological and obstetric care.

[Psychological Stress and its Consequences for the Cost of Illness: a Longitudinal Study in Germany]. / Psychische Belastung und ihre Folgen für die Krankheitskosten ­ eine Längsschnittstudie in Deutschland.

OBJECTIVE: The aim of this study was to examine the effects of mental illness on the level and composition of medical costs (outpatient costs, hospital costs, rehabilitation costs, drug costs) over time. METHOD: In a longitudinal design, we examined the psychological distress of 3,287 study participants from the adult general population using the Hospital Anxiety and Depression Scale (HADS) and its effect on the level and composition of medical costs resulting from mental illness in the year of survey t0 and the two subsequent years [t1] {t2}. RESULTS: Compared to the reference group with no mental distress, the cost of illness was significantly increased by a factor of 2.0 [2.2] {1.5} in the low mental distress group, by a factor of 3.7 [4.2] {3.1} in those with moderate mental distress, and by a factor of 7.5 [9.0] {5.2} in those with severe mental distress. Over time, significant effects on illness costs appeared only at the two outer edges of psychological distress levels (no and severe distress levels). As the level of mental distress increased, hospital costs dominated total costs due to mental distress and the proportion of outpatient medical costs in total costs decreased. CONCLUSIONS: The costs of illness rise steeply with the degree of mental stress. Preventing the progression of mental illness is therefore important not only from an individual but also from a health economic perspective.

Media use in gynecological and obstetric care and women's perceived level of education received of lifestyle-related risks: A cross-sectional study.

OBJECTIVE: The application of media on lifestyle-related risk factors (LRRFs) by healthcare providers to educate women may improve women's adherence, health literacy, and awareness of LRRFs, as well as offspring's health outcomes. This study investigated whether exposure to media-based education in gynecological and obstetric care is associated with LRRFs perceived levels of education received during pregnancy and lactation. METHODS: We conducted a cross-sectional, observational study across 14 randomly generated sample points in the 12 most populated cities in Baden-Württemberg, southwest Germany. Women were recruited from gynecological and obstetric institutions. Participants were 219 women who met our inclusion criteria and completed the quantitative questionnaire. We applied ordinal logistic regression analyses to calculate odds ratios (ORs) and 95% confidence intervals (CIs) of women's perceived level of education received related to healthcare providers' exposure to media-based education. RESULTS: Media-based education on LRRFs during pregnancy through gynecologists and/or midwives were significantly associated with women's perceived level of education received (gynecologists: OR = 4.26 (95% CI: 2.04, 8.90; p < .001); midwives: OR = 3.86 (95% CI: 1.66, 8.98; p = .002)). Similar results were found for media-based education through gynecologists and/or midwives on LRRFs during lactation and its association with women's self-assessed level of perceived level of education received (gynecologists: OR = 4.76 (95% CI: 2.15, 10.56; p < .001); midwives: OR = 7.61 (95% CI: 3.13, 18.53; p < .001)). CONCLUSIONS: This study suggests that the exposure to media-based education in gynecological and obstetric care increases women's perceived level of education received of LRRFs during pregnancy and lactation. Therefore, it is recommendable to apply media in gynecological and obstetric care settings.

Women's Media Use and Preferences of Media-Based Interventions on Lifestyle-Related Risk Factors in Gynecological and Obstetric Care: A Cross-Sectional Multi-Center Study in Germany.

This study aimed to investigate factors affecting (1) women's media use regarding health-related behaviors during pregnancy and lactation, (2) women's preferences for media format, and (3) the content of media-based interventions on lifestyle-related risk factors during pregnancy and lactation. A cross-sectional observational multi-center study of pregnant and lactating women and women of childbearing age was carried out in 14 randomly selected obstetric and gynecologic care settings in the 12 most populated cities in Baden-Wuerttemberg, South-West Germany. Data from 219 surveyed women showed that older women, pregnant women, and lactating women have a higher probability of using media during pregnancy and lactation, respectively. The majority of women preferred a combination of analog and digital media-based interventions in gynecological (46.9%) and obstetric (47.1%) care settings and at home (73.0%). Women would like to see information brochures and flyers on health-related behaviors during pregnancy and lactation for use in gynecological and obstetric care settings, and for media use at home, they would like to have books. The probability of preferring the favored media formats in gynecological and obstetric care settings and at home were associated with pregnancy status, relationship status, socioeconomic status (SES), ethnicity, and health insurance status. About 80% of the surveyed women preferred media content regarding recommendations for a healthy lifestyle and healthy behavior during pregnancy and lactation. All of the independent variables were associated with the probability of preferring a specific media content. The SES was found to play a major role in the probability of preferring a specific media content, followed by pregnancy status, ethnicity, and health insurance status. The results from our study provide a basis for tailored preventive interventions in gynecological and obstetric care settings and for use at home. The results imply that a woman can be reached before conception, during pregnancy, or during lactation with preventive measures tailored to their requirements; however, acceptance may vary across personal attributes, such as SES, ethnicity, and others.

Socio-economic consequences of mental distress: quantifying the impact of self-reported mental distress on the days of incapacity to work and medical costs in a two-year period: a longitudinal study in Germany.

BACKGROUND: Mental disorders are related to high individual suffering and significant socio-economic burdens. However, it remains unclear to what extent self-reported mental distress is related to individuals' days of incapacity to work and their medical costs. This study aims to investigate the impact of self-reported mental distress for specific and non-specific days of incapacity to work and specific and non-specific medical costs over a two-year span. METHOD: Within a longitudinal research design, 2287 study participants' mental distress was assessed using the Hospital Anxiety and Depression Scale (HADS). HADS scores were included as predictors in generalized linear models with a Tweedie distribution with log link function to predict participants' days of incapacity to work and medical costs retrieved from their health insurance routine data during the following two-year period. RESULTS: Current mental distress was found to be significantly related to the number of specific days absent from work and medical costs. Compared to participants classified as no cases by the HADS (2.6 days), severe case participants showed 27.3-times as many specific days of incapacity to work in the first year (72 days) and 10.3-times as many days in the second year (44 days), and resulted in 11.4-times more medical costs in the first year (2272 EUR) and 6.2-times more in the second year (1319 EUR). The relationship of mental distress to non-specific days of incapacity to work and non-specific medical costs was also significant, but mainly driven from specific absent days and specific medical costs. Our results also indicate that the prevalence of presenteeism is considerably high: 42% of individuals continued to go to work despite severe mental distress. CONCLUSIONS: Our results show that self-reported mental distress, assessed by the HADS, is highly related to the days of incapacity to work and medical costs in the two-year period. Reducing mental distress by improving preventive structures for at-risk populations and increasing access to evidence-based treatments for individuals with mental disorders might, therefore, pay for itself and could help to reduce public costs.

Health Knowledge of Lifestyle-Related Risks during Pregnancy: A Cross-Sectional Study of Pregnant Women in Germany.

This study aimed to investigate (1) pregnant women's level of knowledge of lifestyle-related risk factors during pregnancy and their potential health impact on their offspring, and (2) the factors affecting women's knowledge of lifestyle-related risk factors during pregnancy. A cross-sectional observational study of pregnant women was carried out in obstetric and gynecologic care settings at three hospitals in Southern Germany. Data from 209 pregnant women revealed large knowledge gaps on lifestyle-related risk factors during pregnancy and their potential health impact. Factors affecting women's knowledge of lifestyle-related risk factors during pregnancy were specifically associated with socioeconomic status, e.g., lower household net income, middle educational level, and statutory health insurance status. Women who had received information from their gynecologist had a higher level of knowledge of lifestyle-related risk factors during pregnancy. This study showed that health promotion regarding lifestyle-related risks during pregnancy specifically needs to address women from the low-to-middle socioeconomic status group. Gynecologists seem particularly effective in providing this information.

Taxation of the fat content of foods for reducing their consumption and preventing obesity or other adverse health outcomes.

BACKGROUND: Overweight and obesity are increasing worldwide and are considered to be a major public health issue of the 21st century. Introducing taxation of the fat content in foods is considered a potentially powerful policy tool to reduce consumption of foods high in fat or saturated fat, or both. OBJECTIVES: To assess the effects of taxation of the fat content in food on consumption of total fat and saturated fat, energy intake, overweight, obesity, and other adverse health outcomes in the general population. SEARCH METHODS: We searched CENTRAL, Cochrane Database of Systematic Reviews, MEDLINE, Embase, and 15 other databases and trial registers on 12 September 2019. We handsearched the reference lists of all records of included studies, searched websites of international organizations and institutions (14 October 2019), and contacted review advisory group members to identify planned, ongoing, or unpublished studies (26 February 2020). SELECTION CRITERIA: In line with Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria, we included the following study types: randomized controlled trials (RCTs), cluster-randomized controlled trials (cRCTs), non-randomized controlled trials (nRCTs), controlled before-after (CBA) studies, and interrupted time series studies. We included studies that evaluated the effects of taxes on the fat content in foods. Such a tax could be expressed as sales, excise, or special value added tax (VAT) on the final product or an intermediary product. Eligible interventions were taxation at any level, with no restriction on the duration or the implementation level (i.e. local, regional, national, or multinational). Eligible study populations were children (zero to 17 years) and adults (18 years or older) from any country and setting. We excluded studies that focused on specific subgroups only (e.g. people receiving pharmaceutical intervention; people undergoing a surgical intervention; ill people who are overweight or obese as a side effect, such as those with thyroiditis and depression; and people with chronic illness). Primary outcomes were total fat consumption, consumption of saturated fat, energy intake through fat, energy intake through saturated fat, total energy intake, and incidence/prevalence of overweight or obesity. We did not exclude studies based on country, setting, comparison, or population. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods for all phases of the review. Risk of bias of the included studies was assessed using the criteria of Cochrane's 'Risk of bias' tool and the EPOC Group's guidance. Results of the review are summarized narratively and the certainty of the evidence was assessed using the GRADE approach. These steps were done by two review authors, independently. MAIN RESULTS: We identified 23,281 records from searching electronic databases and 1173 records from other sources, leading to a total of 24,454 records. Two studies met the criteria for inclusion in the review. Both included studies investigated the effect the Danish tax on saturated fat contained in selected food items between 2011 and 2012. Both studies used an interrupted time series design. Neither included study had a parallel control group from another geographic area. The included studies investigated an unbalanced panel of approximately 2000 households in Denmark and the sales data from a specific Danish supermarket chain (1293 stores). Therefore, the included studies did not address individual participants, and no restriction regarding age, sex, and socioeconomic characteristics were defined. We judged the overall risk of bias of the two included studies as unclear. For the outcome total consumption of fat, a reduction of 41.8 grams per week per person in a household (P < 0.001) was estimated. For the consumption of saturated fat, one study reported a reduction of 4.2% from minced beef sales, a reduction of 5.8% from cream sales, and an increase of 0.5% to sour cream sales (no measures of statistical precision were reported for these estimates). These estimates are based on a restricted number of food types and derived from sales data; they do not measure individual intake. Moreover, these estimates do not account for other relevant sources of fat intake (e.g. packaged or processed food) or other food outlets (e.g. restaurants or cafeterias); hence, we judged the evidence on the effect of taxation on total fat consumption or saturated fat consumption to be very uncertain. We did not identify evidence on the effect of the intervention on energy intake or the incidence or prevalence of overweight or obesity. AUTHORS' CONCLUSIONS: Given the very low quality of the evidence currently available, we are unable to reliably establish whether a tax on total fat or saturated fat is effective or ineffective in reducing consumption of total fat or saturated fat. There is currently no evidence on the effect of a tax on total fat or saturated fat on total energy intake or energy intake through saturated fat or total fat, or preventing the incidence or reducing the prevalence of overweight or obesity.

[Control group formation using propensity score matching: The role of primary and secondary data - Results of prevention studies]. / Kontrollgruppenbildung durch Propensity-Score-Matching: Die Rolle von Primär- und Sekundärdaten − Ergebnisse aus Präventionsstudien.

BACKGROUND: The creation of control groups in the evaluation of statutory health insurances is a key issue. Randomization represents both an ethical and a legal problem with legally guaranteed services. Matching procedures are relevant alternatives in the construction of control groups. Matchings are mostly based on secondary data from statutory health insurances (for example age, gender, cost of illness, days of incapacity to work). In this study, we examined whether matching based on secondary data alone can cause selection bias. METHODS: We used data from three large prevention studies and applied sensitivity analyses to compare the results of propensity score matchings used to create control groups on the basis of secondary data, with those obtained on the basis of both primary and secondary data. Analysis of covariance was used to investigate the impact of potential selection bias on cost effects. RESULTS: Matchings based on secondary data alone lead to control groups with similar characteristics captured by secondary data. However, the control group participants are significantly healthier (they have, for example, lower levels of pain, lower levels of psychological stress, a higher degree of quality of life) than the patients in intervention groups. This selection bias would lead to a systematic underestimation of the cost reduction produced by preventive interventions. DISCUSSION: Prevention course participants seem to have characteristics that differ from the average population (higher health orientation level, preference for prevention over medical treatment services, etc.) and cannot be captured by secondary data; therefore, matchings based on secondary data alone cause selection bias. CONCLUSIONS: Including both primary and secondary data reduces the risk of selection bias in matching procedures for prevention studies. The E-value can be used to evaluate the robustness of results with regard to selection bias.