Testing a single item screener to support family doctors in identifying patients with limited health literacy: convergent validity of the SILS and the HLS-EU-Q16.

BACKGROUND: Low health literacy (HL) is associated with reduced disease self-management skills, worse health outcomes, an increased number of hospitalizations, more frequent use of the emergency room and less utilization of preventive services. To support patients with low HL it is crucial to identify affected patients. HL is a multidimensional construct, which covers different skills and abilities to make informed health decisions. Validated brief screening tools to assess health-literacy-related skills or abilities in primary care settings are currently not available in German. This study aimed to validate a single item screener developed in the US for the German primary care setting. METHODS: Our study used cross-sectional data from a survey among mainly chronically ill patients (n = 346) conducted in family practices in the state of North Rhine-Westphalia. We explored the convergent validity between a single item literacy screener (SILS) and the HLS-EU-Q16. The SILS measures functional HL by asking patients about their need for help when reading information materials. The HLS-EU-Q16 is a multidimensional HL measure frequently used for research purposes in Germany. Associations between the two instruments were examined using Spearman's correlations and regression analyses. The diagnostic performance of the SILS relative to the HLS-EU-Q16 was assessed using receiver operator curves (ROC). RESULTS: The SILS had a statistically significant correlation with the HLS-EU-Q16 (Spearman ρ: 0.35) and explained 26% of its total variance. Stratified analyses of the convergent validity between both instruments by age, sex, migration background, education level and chronic disease status showed moderate statistically significant correlations in all subgroups (range: 0.223 to 0.428). With an area under the curve of 0.66, the receiver operator curve indicated a satisfactory diagnostic performance of the SILS relative to the HLS-EU-Q16. CONCLUSIONS: The SILS provided an acceptable initial assessment of HL limitations among a heterogeneous population of mainly chronically ill patients in a primary care setting. With only one item, the SILS can be a short and effective tool for routine use in primary care and specialized care settings. Future research should test the SILS in other populations and pilot applications of the SILS in routine care.

Transforming Health Care Delivery towards Value-Based Health Care in Germany: A Delphi Survey among Stakeholders.

Value-based healthcare (VBC) represents one strategy to meet growing challenges in healthcare systems. To date, VBC is not implemented broadly in the German healthcare system. A Delphi survey was conducted to explore stakeholders' perspectives on the relevance and feasibility of actions and practices related to the implementation of VBC in the German healthcare system. Panellists were selected using purposive sampling. Two iterative online survey rounds were conducted which were preceded by a literature search and semi-structured interviews. After two survey rounds, a consensus was reached on 95% of the items in terms of relevance and on 89% of the items regarding feasibility. The expert panels' responses were in favor of the presented actions and practices of VBC in 98% of items for which consensus was found (n = 101). Opposition was present regarding the relevance of health care being provided preferably in one location for each indication. Additionally, the panel considered inter-sectoral joint budgets contingent on treatment outcomes achieved as not feasible. When planning the next steps in moving towards a value-based healthcare system, policymakers should take into account this study's results on stakeholders' perceptions of the relative importance and feasibility of VBC components. This ensures that regulatory changes are aligned with stakeholder values, facilitating greater acceptance and more successful implementation.

CAT HPPR: a critical appraisal tool to assess the quality of systematic, rapid, and scoping reviews investigating interventions in health promotion and prevention.

BACKGROUND: For over three decades researchers have developed critical appraisal tools (CATs) for assessing the scientific quality of research overviews. Most established CATs for reviews in evidence-based medicine and evidence-based public health (EBPH) focus on systematic reviews (SRs) with studies on experimental interventions or exposure included. EBPH- and implementation-oriented organisations and decision-makers, however, often seek access to rapid reviews (RRs) or scoping reviews (ScRs) for rapid evidence synthesis and research field exploration. Until now, no CAT is available to assess the quality of SRs, RRs, and ScRs following a unified approach. We set out to develop such a CAT. METHODS: The development process of the Critical Appraisal Tool for Health Promotion and Prevention Reviews (CAT HPPR) included six phases: (i) the definition of important review formats and complementary approaches, (ii) the identification of relevant CATs, (iii) prioritisation, selection and adaptation of quality criteria using a consensus approach, (iv) development of the rating system and bilingual guidance documents, (v) engaging with experts in the field for piloting/optimising the CAT, and (vi) approval of the final CAT. We used a pragmatic search approach to identify reporting guidelines/standards (n = 3; e.g. PRISMA, MECIR) as well as guidance documents (n = 17; e.g. for reviews with mixed-methods approach) to develop working definitions for SRs, RRs, ScRs, and other review types (esp. those defined by statistical methods or included data sources). RESULTS: We successfully identified 14 relevant CATs, predominantly for SRs (e.g. AMSTAR 2), and extracted 46 items. Following consensual discussions 15 individual criteria were included in our CAT and tailored to the review types of interest. The CAT was piloted with 14 different reviews which were eligible to be included in a new German database looking at interventions in health promotion and prevention in different implementation settings. CONCLUSIONS: The newly developed CAT HPPR follows a unique uniformed approach to assess a set of heterogeneous reviews (e.g. reviews from problem identification to policy evaluations) to assist end-users needs. Feedback of external experts showed general feasibility and satisfaction with the tool. Future studies should further formally test the validity of CAT HPPR using larger sets of reviews.

Health-related quality of life after 50 years in individuals with thalidomide embryopathy: Evidence from a German cross-sectional survey.

BACKGROUND: As individuals with thalidomide embryopathy now reaching their 60's they undergo long-term sequelae of their prenatal damage and experience a wide range of secondary health problems, in particular chronic musculoskeletal pain, movement restrictions, and mental disorders. These health problems are having a negative impact on their life circumstances and their health-related quality of life (HRQOL). OBJECTIVE: The aim of this study was to determine the HRQOL in individuals with thalidomide embryopathy in comparison to individuals of the age-adjusted general population in Germany with and without chronic disease conditions (primary outcome). And, further explore the influence of impairment patterns, pain stage, and mental disorders on physical and mental dimensions of HRQOL (secondary outcome). METHODS: A cross-sectional survey of 202 individuals with thalidomide embryopathy from North Rhine-Westphalia/Germany was conducted, which gathered information about physical examinations including a standardized determination of the pain stage, a structured psychological interview, and the HRQOL. The final dataset was 186 cases for primary outcome. RESULTS: Individuals with thalidomide embryopathy (50.6 years, 55.9% females) show a significantly reduced physical HRQOL comparison to the age-adjusted German population with chronic diseases (physical component score; pcs: 33.4 vs. 45.3, p < .001). In addition, male individuals with thalidomide embryopathy show a significantly reduced mental HRQOL to their male counterparts in this comparison (mental component score; mcs: 45.0 vs. 50.0, p = .005). The subgroup analyses show that individuals with thalidomide embryopathy with quadruple impairment have a significantly lower physical HRQOL than those with hearing loss (pcs: 25.0 vs. 38.5; ci's not overlapping). Second, individuals with thalidomide embryopathy with severe compared to mild stages of pain have significantly poorer levels of physical and mental HRQOL (pcs: 25.8 vs. 37.7, ci not overlapping; mcs: 40.4 vs. 51.8, ci's not overlapping). And, individuals with thalidomide embryopathy without a mental disorder show a high mental HRQOL (mcs: 53.2), while in comparison to the total sample those with somatoform and personality disorders have a significantly reduced physical HRQOL (pcs: 27.5 and 24.8; both ci's not overlapping), and those with depressive disorders have a significant reduced mental HRQOL (mcs: 38.0 vs. 45.8, ci's not overlapping). CONCLUSIONS: A longitudinal decreasing HRQOL in individuals with thalidomide embryopathy is known, as well as high prevalence of mental disorders and chronic pain syndromes. This study shows a strong association between these two influencing factors and a poor HRQOL.

Health Literacy among Pregnant Women in a Lifestyle Intervention Trial.

Health literacy plays a crucial role during pregnancy, influencing the mother's health behavior which in turn affects the unborn child's health. To date, there are only few studies that report on health literacy among pregnant women or even interventions to promote health literacy. GeMuKi (acronym for "Gemeinsam Gesund: Vorsorge plus für Mutter und Kind"-Strengthening health promotion: enhanced check-up visits for mother and child) is a cluster-randomized controlled trial, aimed at improving health literacy in pregnant women by means of a lifestyle intervention in the form of brief counseling. The women in the intervention group receive counseling on lifestyle topics, such as nutrition and physical activity, during their regular prenatal check-ups. The counseling is tailored to the needs of pregnant women. Demographic data is collected at baseline using a paper-based questionnaire. Data on health literacy is collected using the Health Literacy Survey Europe with 16 items (HLS-EU-16) at baseline and the Brief Health Literacy Screener (BHLS) questionnaire at two points during the pregnancy by means of an app, which was developed specifically for the purpose of the project. The results of the study indicate that around 61.9% of the women participating in the GeMuKi study have an adequate level of health literacy at baseline. The regression analyses (general estimating equations) showed no significant effect of the GeMuKi intervention on general health literacy as measured by the BHLS (ß = 0.086, 95% CI [-0.016-0.187]). However, the intervention was significantly positively associated with pregnancy specific knowledge on lifestyle (ß = 0.089, 95% CI [0.024-0.154]). The results of this study indicate that GeMuKi was effective in improving specific pregnancy related knowledge, but did not improve general health literacy.

Effectiveness of a Brief Lifestyle Intervention in the Prenatal Care Setting to Prevent Excessive Gestational Weight Gain and Improve Maternal and Infant Health Outcomes.

Research on perinatal programming shows that excessive gestational weight gain (GWG) increases the risk of overweight and obesity later in a child's life and contributes to maternal weight retention and elevated risks of obstetrical complications. This study examined the effectiveness of a brief lifestyle intervention in the prenatal care setting, compared to routine prenatal care, in preventing excessive GWG as well as adverse maternal and infant health outcomes. The GeMuKi study was designed as a cluster RCT using a hybrid effectiveness implementation design and was conducted in the prenatal care setting in Germany. A total of 1466 pregnant women were recruited. Pregnant women in intervention regions received up to six brief counseling sessions on lifestyle topics (e.g., physical activity, nutrition, drug use). Data on GWG and maternal and infant outcomes were entered into a digital data platform by the respective healthcare providers. The intervention resulted in a significant reduction in the proportion of women with excessive GWG (OR = 0.76, 95% CI (0.60 to 0.96), p = 0.024). Gestational weight gain in the intervention group was reduced by 1 kg (95% CI (−1.56 to −0.38), p < 0.001). No evidence of intervention effects on pregnancy, birth, or neonatal outcomes was found.

Preventive Counseling in Routine Prenatal Care-A Qualitative Study of Pregnant Women's Perspectives on a Lifestyle Intervention, Contrasted with the Experiences of Healthcare Providers.

Maternal lifestyle during pregnancy and excessive gestational weight gain can influence maternal and infant short and long-term health. As part of the GeMuKi intervention, gynecologists and midwives provide lifestyle counseling to pregnant women during routine check-up visits. This study aims to understand the needs and experiences of participating pregnant women and to what extent their perspectives correspond to the experiences of healthcare providers. Semi-structured interviews were conducted with 12 pregnant women and 13 multi-professional healthcare providers, and were analyzed using qualitative content analysis. All interviewees rated routine check-up visits as a good setting in which to focus on lifestyle topics. Women in their first pregnancies had a great need to talk about lifestyle topics. None of the participants were aware of the link between gestational weight gain and maternal and infant health. The healthcare providers interviewed attributed varying relevance regarding the issue of weight gain and, accordingly, provided inconsistent counseling. The pregnant women expressed dissatisfaction regarding the multi-professional collaboration. The results demonstrate a need for strategies to improve multi-professional collaboration. In addition, health care providers should be trained to use sensitive techniques to inform pregnant women about the link between gestational weight gain and maternal and infant health.

Understanding Determinants of Pregnant Women's Knowledge of Lifestyle-Related Risk Factors: A Cross-Sectional Study.

Research indicates that a woman's lifestyle during pregnancy influences her child's health and development. Therefore, women need to possess sufficient knowledge regarding the elements of a healthy lifestyle during pregnancy. To date, there has been little research on the assessment of lifestyle knowledge of pregnant women in the perinatal healthcare setting. This study describes the development and application of a knowledge-based questionnaire for pregnancy to be used in a lifestyle intervention trial conducted in Germany. Within the trial, pregnant women receive counselling on lifestyle topics. These topics are based on the German initiative 'Healthy Start-Young Family Network' (GiL), which provides evidence-based recommendations regarding diet and lifestyle before and during pregnancy. These serve as a basis for health professionals who provide counselling on healthy lifestyle choices during the antenatal period. The questionnaire consists of eight items, each of which can be answered using 'Yes', 'No' or 'Don't know'. The pregnant women who completed the questionnaire at baseline around the twelfth week of gestation were recruited within the host trial from gynaecological practices in Germany. Demographic variables and the respondents' answers to the questionnaire were analysed using descriptive statistics and regression analyses. Descriptive statistics show that more than 85% of participants answered the majority of questions (n = 5) correctly. Questions on whether tap water is safe and the normal range for gestational weight gain (GWG) were answered correctly by about 62% and 74% of the women, respectively, and the question on whether it is beneficial to obtain information on breastfeeding at an early stage was answered correctly by about 29%. The results of the regression analyses indicate that age, gestational week, education and income are positive predictors for answering the questionnaire correctly. Nullipara and migration background are predictors for answering the questions incorrectly. This study indicates that there are gaps in women's knowledge regarding lifestyle during pregnancy. Particular focus on certain topics, such as breastfeeding and normal GWG ranges, is still required during counselling. Our analysis shows that migration background is a predictor of insufficient knowledge and incorrect answers to the questions. Women with such backgrounds require special attention during antenatal counselling in order to cater to their needs and the gaps in their knowledge.

Methodological issues in economic evaluations of disease prevention and health promotion: an overview of systematic and scoping reviews.

BACKGROUND: We aimed to provide a comprehensive overview of methodological challenges in economic evaluations of disease prevention and health promotion (DPHP)-measures. METHODS: We conducted an overview of reviews searching MEDLINE, EMBASE, NHS Economic Evaluation Database, Database of Promoting Health Effectiveness Reviews, Cochrane Database of Systematic Reviews (CDSR) and Database of Promoting Health Effectiveness Reviews (DOPHER) (from their inception to October 2021). We included both systematic and scoping reviews of economic evaluations in DPHP addressing following methodological aspects: (i) attribution of effects, (ii) outcomes, (iii) inter-sectoral (accruing to non-health sectors of society) costs and consequences and (iv) equity. Data were extracted according to the associated sub-criteria of the four methodological aspects including study design economic evaluation (e.g. model-based), type/scope of the outcomes (e.g. outcomes beyond health), perspective, cost categories related to non-health sectors of society, and consideration of equity (method of inclusion). Two reviewers independently screened all citations, full-text articles, and extracted data. A narrative synthesis without a meta-analysis or other statistical synthesis methods was conducted. RESULTS: The reviewing process resulted in ten systematic and one scoping review summarizing 494 health economic evaluations. A lifelong time horizon was adopted in about 23% of DPHP evaluations, while 64% of trial-based evaluations had a time horizon up to 2 years. Preference-based outcomes (36%) and non-health outcomes (8%) were only applied in a minority of studies. Although the inclusion of inter-sectoral costs (i.e. costs accruing to non-health sectors of society) has increased in recent years, these were often neglected (between 6 and 23% depending on the cost category). Consideration to equity was barely given in economic evaluations, and only addressed in six of the eleven reviews. CONCLUSIONS: Economic evaluations of DPHP measures give only little attention to the specific methodological challenges related to this area. For future economic DPHP evaluations a tool with structured guidance should be developed. This overview of reviews was not registered and a published protocol does not exist.

Recruitment in Health Services Research-A Study on Facilitators and Barriers for the Recruitment of Community-Based Healthcare Providers.

In health services research, the recruitment of patients is oftentimes conducted by community-based healthcare providers. Therefore, the recruitment of these healthcare providers is a crucial prerequisite for successful patient recruitment. However, recruiting community-based healthcare providers poses a major challenge and little is known about its influencing factors. This qualitative study is conducted alongside a health services research intervention trial. The aim of the study is to investigate facilitators and barriers for the recruitment of community-based healthcare providers. A qualitative text analysis of documents and semi-structured interviews with recruiting staff is performed. An inductive-deductive category-based approach is used. Our findings identify intrinsic motivation and interest in the trial's aims and goals as important facilitating factors in healthcare provider recruitment. Beyond that, extrinsic motivation generated through financial incentives or collegial obligation emerged as a conflicting strategy. While extrinsic motivation might aid in the initial enrollment of healthcare providers, it rarely resulted in active trial participation in the long run. Therefore, extrinsic motivational factors should be handled with care when recruiting healthcare providers for health services research intervention trials.

A cross-sectional analysis of health literacy: patient- versus family doctor-reported and associations with self-efficacy and chronic disease.

BACKGROUND: Adequate health literacy (HL) levels contribute to good health outcomes and successful disease self-management in patients with chronic disease. Hence, it is essential that family doctors recognize patients with inadequate HL in need of additional support. This study had two aims: (1) to assess and compare patient self-reported versus family doctor-rated HL estimates, and (2) to explore associations between patient-reported HL, self-efficacy and chronic diseases. METHODS: Participants in this cross-sectional survey were recruited through general practices in North Rhine-Westphalia, Germany. Patient self-reported HL was measured using the European Health Literacy Survey-16. Family doctor-rated HL was measured with an adapted version of this instrument. Using crosstabulations patient-reported and family doctor-rated HL estimates were compared for 346 patient-family doctor pairs. Associations between HL, self-efficacy and chronic disease were investigated using regression analyses. RESULTS: Patient-reported and family doctor-rated HL estimates were concordant in 38% of all cases. On average family doctors rated their patients' HL lower than patients rated their own HL. The lower average family doctor ratings were more pronounced when patients were older, male and had more than one chronic disease. Female family doctors rated HL of male patients lower than their male colleagues. Patient reported HL had a significant positive association with self-efficacy. Mediation analysis provided support that self-efficacy acts as mediator between HL and the number of chronic diseases. CONCLUSIONS: Our study findings indicate a significant discrepancy between patients' self-reported HL and externally rated HL by family doctors. A more systematic utilization of HL screeners might help reduce this discrepancy. At the same time, consideration should be given to enhancing communication training for family doctors and addressing critical HL skills in patient education.

[Prospects for the implementation of the Innovation Fund project GeMuKi - a cross sectional study on attitudes of health care providers regarding preventive lifestyle counselling in routine prenatal visits and infant check-ups]. / Perspektiven für die Implementierung des Innovationsfondsprojekt GeMuKi: Eine Querschnittserhebung der Einstellungen von Leistungserbringern zu einer präventiven Lebensstilberatung in den Schwangerschafts- und Kindervorsorgeuntersuchungen.

INTRODUCTION: Overweight and obesity are major public health concerns in Germany. As patients can easily be accessed via physicians' offices, this setting provides a high potential for prevention. However, the limited implementation of prevention and health promotion interventions in physicians' offices so far indicates that barriers to implementation exist. This study therefore addresses how obesity prevention interventions should be designed and implemented so that health care providers perceive them as appropriate and are willing to adopt them in their daily practice. The study is performed by taking the Innovation Fund project "GeMuKi" as an example. METHODS: A mixed-methods study was conducted. Data collection took place within the context of the GeMuKi training session that health care providers complete in preparation for implementing the intervention. Gynecologists, pediatricians, midwives, and medical assistants completed a questionnaire. The questions covered the implementation outcomes "appropriateness" and "adoption". Text entry fields were used to obtain information on feasibility as well as anticipated facilitating and hindering factors. In addition, observation protocols were prepared for each training session by the project team. The questionnaire was analyzed descriptively. Text entry fields and protocols were evaluated using qualitative content analysis. RESULTS: Four hundred and one (n=401) training participants completed the questionnaire. Almost three quarters (73 %) of the health care providers indicate that they are motivated to implement the intervention. At the same time, concerns are expressed about organizational feasibility in everyday practice. Nevertheless, 72 % expect their care to improve as a result of the project. CONCLUSION: The health care providers surveyed are positive about the implementation of the project in everyday practice. By documenting concerns about the implementation, the barriers identified can be addressed during the project course.

Health literacy among pregnant women in a lifestyle intervention trial: protocol for an explorative study on the role of health literacy in the perinatal health service setting.

INTRODUCTION: Pregnancy is a vulnerable period that affects long-term health of pregnant women and their unborn infants. Health literacy plays a crucial role in promoting healthy behaviour and thereby maintaining good health. This study explores the role of health literacy in the GeMuKi (acronym for 'Gemeinsam Gesund: Vorsorge plus für Mutter und Kind'-Strengthening health promotion: enhanced check-up visits for mother and child) Project. It will assess the ability of the GeMuKi lifestyle intervention to positively affect health literacy levels through active participation in preventive counselling. The study also explores associations between health literacy, health outcomes, health service use and effectiveness of the intervention. METHODS AND ANALYSIS: The GeMuKi trial has a hybrid effectiveness-implementation design and is carried out in routine prenatal health service settings in Germany. Women (n=1860) are recruited by their gynaecologist during routine check-up visits before 12 weeks of gestation. Trained healthcare providers carry out counselling using motivational interviewing techniques to positively affect health literacy and lifestyle-related risk factors. Healthcare providers (gynaecologists and midwives) and women jointly agree on Specific, Measurable, Achievable Reasonable, Time-Bound goals. Women will be invited to fill in questionnaires at two time points (at recruitment and 37th-40th week of gestation) using an app. Health literacy is measured using the German version of the Health Literacy Survey-16 and the Brief Health Literacy Screener. Lifestyle is measured with questions on physical activity, nutrition, alcohol and drug use. Health outcomes of both mother and child, including gestational weight gain (GWG) will be documented at each routine visit. Health service use will be assessed using social health insurance claims data. Data analyses will be conducted using IBM SPSS Statistics, version 26.0. These include descriptive statistics, tests and regression models. A mediation model will be conducted to answer the question whether health behaviour mediates the association between health literacy and GWG. ETHICS AND DISSEMINATION: The study was approved by the University Hospital of Cologne Research Ethics Committee (ID: 18-163) and the State Chamber of Physicians in Baden-Wuerttemberg (ID: B-F-2018-100). Study results will be disseminated through (poster) presentations at conferences, publications in peer-reviewed journals and press releases. TRAIL REGISTRATION: German Clinical Trials Register (DRKS00013173). Registered pre-results, 3rd of January 2019, https://www.drks.de.

[Insights for healthy settings: a database to support the translation of findings from systematic reviews into practice]. / Wissen für gesunde Lebenswelten: Eine Datenbank zum Praxistransfer von Erkenntnissen aus systematischen Übersichtsarbeiten.

The database "Insights for healthy settings" was developed by the GKV-Bündnis für Gesundheit, a joint initiative of all health insurance funds for developing and implementing setting-based health promotion and prevention measures. It aims to support health insurance funds and other practice partners in planning and implementing evidence-based health promotion and prevention measures in different settings. The database complements existing intervention databases by providing insights based on findings from systematic reviews. This article aims to present the database, describe possible applications, and discuss options for further development.The database contains findings on the effectiveness and strategies for implementation of setting-based health promotion and prevention measures. In addition to structured summaries of systematic reviews, it includes summaries of scoping reviews and rapid reviews. Different search options (e.g., free text search, subject headings, and search filters) can be used to find database entries (currently n = 13). Quality-assured database entries are created by means of a standardized form and based on the four-eyes principle. To allow for easy access, key findings are presented briefly, and technical terms are clarified. Experts from health insurance funds are continuously involved in the development process of the database.As part of the database's further development, new reviews of the GKV-Bündnis für Gesundheit as well as from other sources will be added. Additionally, quality assessments of included reviews will be depicted and supporting activities developed to further encourage translation of scientific knowledge into practice.

Evaluation of a computer-assisted multi-professional intervention to address lifestyle-related risk factors for overweight and obesity in expecting mothers and their infants: protocol for an effectiveness-implementation hybrid study.

BACKGROUND: The first 1000 days after conception are a critical period to encourage lifestyle changes to reduce the risk of childhood obesity and early programming of chronic diseases. A healthy lifestyle during pregnancy is also crucial to avoid high post-partum weight retention. Currently, lifestyle changes are not consistently discussed during routine health services in Germany. The objective of this study is to evaluate a novel computer-assisted lifestyle intervention embedded in prenatal visits and infant check-ups. The intervention seeks to reduce lifestyle-related risk factors for overweight and obesity among expecting mothers and their infants. METHODS: The study is designed as a hybrid effectiveness-implementation trial to simultaneously collect data on the effectiveness and implementation of the lifestyle intervention. The trial will take place in eight regions of the German state Baden-Wuerttemberg. Region were matched using propensity score matching. Expecting mothers (n = 1860) will be recruited before 12 weeks of gestation through gynecological practices and followed for 18 months. During 11 routine prenatal visits and infant check-ups gynecologists, midwives and pediatricians provide lifestyle counseling using Motivational Interviewing techniques. The primary outcome measure is the proportion of expecting mothers with gestational weight gain within the recommended range. To understand the process of implementation (focus group) interviews will be conducted with providers and participants of the lifestyle intervention. Additionally, an analysis of administrative data and documents will be carried out. An economic analysis will provide insights into cost and consequences compared to routine health services. DISCUSSION: Findings of this study will add to the evidence on lifestyle interventions to reduce risk for overweight and obesity commenced during pregnancy. Insights gained will contribute to the prevention of early programming of chronic disease. Study results regarding implementation fidelity, adoption, reach and cost-effectiveness of the lifestyle intervention will inform decisions about scale up and public funding. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00013173). Registered 3rd of January 2019, https://www.drks.de.