Addressing psychosocial needs in patients with Long-COVID (PsyLoCo-Study): study protocol of a pilot-study of a specialized modular intervention.

Introduction: After an acute infection with the corona virus 10-20% of those affected suffer from ongoing or new symptoms. A causal therapy for the phenomenon known as Long/Post-COVID is still lacking and specific therapies addressing psychosocial needs of these patients are imperatively needed. The aim of the PsyLoCo-study is developing and piloting a psychotherapeutic manual, which addresses Long/Post-COVID-related psychosocial needs and supports in coping with persistent bodily symptoms as well as depressive or anxiety symptoms. Methods and analysis: This pilot trial implements a multi-centre, 2-arm (N=120; allocation ratio: 1:1), parallel group, randomised controlled design. The pilot trial is designed to test the feasibility and estimate the effect of 1) a 12-session psychotherapeutic intervention compared to 2) a wait-list control condition on psychosocial needs as well as bodily and affective symptoms in patients suffering from Long/Post-COVID. The intervention uses an integrative, manualized, psychotherapeutic approach. The primary study outcome is health-related quality of life. Outcome variables will be assessed at three timepoints, pre-intervention (t1), post-intervention (t2) and three months after completed intervention (t3). To determine the primary outcome, changes from t1 to t2 are examined. The analysis will be used for the planning of the RCT to test the efficacy of the developed intervention. Discussion: The pilot study will evaluate a 12-session treatment manual for Long/Post-COVID sufferers and the therapy components it contains. The analysis will provide insights into the extent to which psychotherapeutic treatment approaches improve the symptoms of Long/Post-COVID sufferers. The treatment manual is designed to be carried out by psychotherapists as well as people with basic training in psychotherapeutic techniques. This approach was chosen to enable a larger number of practitioners to provide therapeutic support for Long/Post-COVID patients. After completion of the pilot study, it is planned to follow up with a randomized controlled study and to develop a treatment guideline for general practitioners and interested specialists. Trial registration: The pilot trial has been registered with the German Clinical Trials Register (Deutsches Register Klinischer Studien; Trial-ID: DRKS00030866; URL: https://drks.de/search/de/trial/DRKS00030866) on March 7, 2023.

The Predominance of the Health-Promoting Patterns of Work Behavior and Experience in General Practice Teams-Results of the IMPROVEjob Study.

This study aims to identify the distribution of the "Work-related behavior and experience patterns" (Arbeitsbezogenes Verhaltens-und Erlebnismuster, AVEM) in general practitioners and their teams by using baseline data of the IMPROVEjob study. Members of 60 general practices with 84 physicians in a leadership position, 28 employed physicians, and 254 practice assistants participated in a survey in 2019 and 2020. In this analysis, we focused on AVEM variables. Age, practice years, work experience, and working time were used as control variables in the Spearman Rho correlations and analysis of variance. The majority of the participants (72.1%) revealed a health-promoting pattern (G or S). Three of eleven AVEM dimensions were above the norm for the professional group "employed physicians". The AVEM dimensions "striving for perfection" (p < 0.001), "experience of success at work" (p < 0.001), "satisfaction with life" (p = 0.003), and "experience of social support" (p = 0.019) differed significantly between the groups' practice owners and practice assistants, with the practice owners achieving the higher values, except for experience of social support. Practice affiliation had no effect on almost all AVEM dimensions. We found a high prevalence of AVEM health-promoting patterns in our sample. Nearly half of the participants in all professional groups showed an unambitious pattern (S). Adapted interventions for the represented AVEM patterns are possible and should be utilized for maintaining mental health among general practice teams.

Improving Well-Being and Fostering Health-Oriented Leadership among Leaders in Small and Medium-Sized Enterprises (SMEs): A Systematic Review.

Leaders of small and medium-sized enterprises (SMEs) are often confronted with specific burdens, which frequently result in increased levels of stress. Leadership behaviour, in turn, has a significant impact on employees' health and performance. Using the Population, Intervention, Comparison, Outcome (PICO) method, we conducted a systematic literature search covering publications from 2002 to 2023 using PubMed, PsycInfo and Business Source Premier on stress-reducing and well-being-improving interventions for SME leaders. The Effective Public Health Practice Project (EPHPP) Quality Assessment Tool was used to assess the methodological quality and risk of bias of the included studies regarding selection bias, study design, confounders, blinding, data collection, withdrawal and drop-out. Of the 3150 identified publications, 6 were included after screening. The studies varied in content (cognitive behavioural therapy [CBT]-based, psychoeducation, and mixed interventions) and approach (individual- and organisation-centred). Not all of the examined interventions provided significant outcomes. However, CBT-based and individualised approaches showed a positive trend in reducing SME leaders' psychosocial stress and improving their well-being. Despite the limited data, it can be concluded that such interventions are beneficial for leaders and their specific needs. Future research should focus on tailored approaches, derived from well-founded theories and integrative interventions addressing SME leaders.

SARS-CoV-2 infection is associated with physical but not mental fatigue - Findings from a longitudinal controlled population-based study.

OBJECTIVE: Fatigue has been identified as the core symptom of long-Covid, however, putative pandemic-related influences remain largely unclear. We investigated trajectories of total, physical and mental fatigue and the factors associated with it in previously infected and non-infected individuals up to one year post- infection. METHODS: We used data from a longitudinal cohort study of German adults with two samples: A representative probability sample and a sample of individuals with proven SARS-CoV-2 infection. Surveys were conducted in spring 2020(T1), autumn 2020(T2) and summer 2021(T3). Fatigue was assessed using the FAS, distinguishes between physical and mental fatigue. Depression, anxiety and stress were assessed using PHQ-4 and PSQ. RESULTS: 1990 participants [mean age 47.2 (SD = 17.0), 30.5% previously infected] were included in the survey at T1 (n = 1118 at T2, n = 692 at T3). Total and physical fatigue, but not mental fatigue were significantly higher in the previously infected compared to the non-infected sample at T2, but this group difference disappeared at T3. We identified Covid-infection as a factor associated with transient total and physical fatigue at T2. Depression, anxiety and stress at T1 were associated with total, physical and mental fatigue at both follow-ups. CONCLUSIONS: Our results highlight the importance of considering physical and mental fatigue as separate entities, while suggesting a greater relevance of the physical signs of fatigue in understanding long-Covid. The results further showed that baseline mental health symptoms were the most strongly associated with fatigue trajectories.

Correlates of physical activity enjoyment in children and adolescents for a new perspective on the treatment of overweight: A systematic literature review.

The purpose of this systematic literature review was to systematically compile the state of knowledge on correlates of physical activity enjoyment in children and adolescents to influence the perspective of future physical activity promotion approaches especially for children and adolescents affected by overweight or obesity. The electronic database search was executed in the five databases PubMed, PsychINFO, SPORTDiscus, Web of Science, and BISp-SURF, from inception to December 6, 2021. A semi-quantitative method was used for summarizing the resulted correlates. For final analysis, 85 studies comprising 48,144 children and adolescents were included. Fifty-seven variables could be coded for their relationship with physical activity enjoyment. Of these, 12 psychological variables, for example, the basic psychological needs, task orientation, or self-efficacy; six interpersonal variables, for example, peer/group acceptance, parental support, and autonomy support; and one behavioral variable, the higher self-reported physical activity, are consistent positively associated to physical activity enjoyment. A scientifically based overview could be extracted for the promotion of physical activity enjoyment in children and adolescents. There is a gap in literature focusing the perception of physical activity enjoyment in the subgroup of children and adolescents affected by overweight or obesity. Therefore, recommendations were made to enable the development of further innovative research approaches in this population.

What helps hospital staff in times of crisis: qualitative results of a survey on psychosocial resources and stressors in German hospitals during the COVID-19 pandemic.

Background: Even before the COVID-19 pandemic, hospital workers faced a tremendous workload. The pandemic led to different and additional strain that negatively affected the well-being of employees. This study aims to explore psychosocial resources and strategies that were used by hospital staff. Methods: In the context of an intervention study, employees of three German hospitals were questioned in writing in summer and fall 2020. Five open-ended questions about the pandemic were asked to capture corresponding effects on daily work routine. Answers of 303 participants were evaluated using structuring qualitative content analysis. Results: Significant stressors and resources were identified in the areas of work content and task, social relations at work, organization of work, work environment and individual aspects. Stressors included, for example, emotional demands, conflicts, an increased workload, time and performance pressure. Important resources mentioned were, among others, the exchange with colleagues and mutual support. Sound information exchange, clear processes and guidelines and a positive work atmosphere were also important. In addition, the private environment and a positive mindset were perceived as helpful. Conclusion: This study contributes to a differentiated understanding of existing psychosocial resources of hospital staff in times of crisis. Identifying and strengthening these resources could reduce stress and improve well-being, making hospital staff better prepared for both normal operations and further crisis situations.

Stress and Depressive and Anxiety Symptoms in the General Population and in SARS-CoV-2-Infected Patients-Findings from a Population-Based Three-Wave Study.

Objective: Understanding factors that impaired mental health during the COVID-19 pandemic is extremely relevant in order to mitigate long-term consequences of the pandemic and to promote resilience in future crises. Method: Data were collected in southern Germany in a population-based survey study (CoKoS) with three times of measurement in May 2020, November 2020 and July 2021. Predictors of depressive and anxiety symptoms were measured with a short version of the Patient Health Questionnaire (PHQ-4) in the general population (N = 758) and individuals who were infected with SARS-CoV-2 in the beginning of the pandemic (N = 412). We investigated differences between both samples and how stress components (worry, tension, demands and joy) measured with the Perceived Stress Questionnaire (PSQ) varied with depressive and anxiety symptoms over time. Three linear mixed models (GLMMs) were fitted to predict the PHQ-4 stepwise, including sociodemographic variables and stress (PSQ). Results: Depressive and anxiety symptoms increased from May 2020 to November 2020 and remained stable until July 2021. There were no differences between people with SARS-CoV-2 infection and the general population. Those with a pre-existing disease and lower education reported higher levels of depressive and anxiety symptoms. Stress explained a substantial fraction of variance in depressive and anxiety symptoms. The stress component worry emerged as the strongest predictor of depressive and anxiety symptoms, whereas joy seemed to buffer these symptoms. Conclusions: The results suggest that mitigating people's worry and increasing joy may promote resilience in future crises. Future studies should assess mental health interventions targeted at vulnerable groups, such as those with lower socioeconomic status and poorer health.

Managers perception of hospital employees' effort-reward imbalance.

OBJECTIVE: Hospitals are frequently associated with poor working conditions that can lead to work stress and increase the risk for reduced employee well-being. Managers can shape and improve working conditions and thereby, the health of their teams. Thus, as a prerequisite, managers need to be aware of their employees' stress levels. This study had two objectives: At first, it aimed to test the criterion validity of the Effort-Reward Imbalance (ERI) questionnaire measuring psychosocial workload in hospital employees. Secondly, mean scales of the ERI questionnaire filled in by employees were compared with mean scales of an adapted ERI questionnaire, in which managers assessed working conditions of their employees. METHODS: Managers (n = 141) from three hospitals located in Germany assessed working conditions of their employees with an adapted external, other-oriented questionnaire. Employees (n = 197) of the mentioned hospitals completed the short version of the ERI questionnaire to assess their working conditions. Confirmatory factor analyses (CFA) were applied to test factorial validity, using the ERI scales for the two study groups. Criterion validity was assessed with multiple linear regression analysis of associations between ERI scales and well-being among employees. RESULTS: The questionnaires demonstrated acceptable psychometric properties in terms of internal consistency of scales, although some indices of model fit resulting from CFA were of borderline significance. Concerning the first objective, effort, reward, and the ratio of effort-reward imbalance were significantly associated with well-being of employees. With regard to the second objective, first tentative findings showed that managers' ratings of their employees' effort at work was quite accurate, whereas their reward was overestimated. CONCLUSIONS: With its documented criterion validity the ERI questionnaire can be used as a screening tool of workload among hospital employees. Moreover, in the context of work-related health promotion, managers' perceptions of their employees' workload deserve increased attention as first findings point to some discrepancies between their perceptions and those provided by employees.

Exploring Transfer Potentials of the IMPROVEjob Intervention for Strengthening Workplace Health Management in Micro-, Small-, and Medium-Sized Enterprises in Germany: A Qualitative Study.

Micro- and small-sized enterprises (MSE), and small- and medium-sized enterprises (SME) in Germany are often burdened with high levels of psychosocial stressors at work. The IMPROVEjob intervention was originally developed for general practice teams, and aims to promote job satisfaction and reduce psychosocial stressors in the context of workplace health management (WHM). This qualitative study identified challenges and transfer options regarding the transfer of the IMPROVEjob intervention to other MSE/SME settings. Based on previous study results, a comprehensive, qualitative inter- and transdisciplinary approach was developed and conducted between July 2020 and June 2021, also including single interviews and focus group discussion with eleven experts from MSE/SME settings. Data analysis was carried out using a rapid analysis approach. The experts discussed psychosocial topics and didactic formats of the original IMPROVEjob intervention. A lack of access to information on managing work-related psychosocial stressors and inadequate recognition of the importance of psychosocial stressors in the workplace among managers and employees, seemed to be the highest barriers regarding the transfer of the intervention into other MSE/SME settings. The transfer of the IMPROVEjob intervention to other MSE/SME settings requires an adapted intervention format, comprising targeted offers with easy access to information on managing work-related psychosocial stressors and improving WHM in MSE/SME settings.

The humoral immune response more than one year after SARS-CoV-2 infection: low detection rate of anti-nucleocapsid antibodies via Euroimmun ELISA.

PURPOSE: Antibody assays against SARS-CoV-2 are used in sero-epidemiological studies to estimate the proportion of a population with past infection. IgG antibodies against the spike protein (S-IgG) allow no distinction between infection and vaccination. We evaluated the role of anti-nucleocapsid-IgG (N-IgG) to identify individuals with infection more than one year past infection. METHODS: S- and N-IgG were determined using the Euroimmun enzyme-linked immunosorbent assay (ELISA) in two groups: a randomly selected sample from the population of Stuttgart, Germany, and individuals with PCR-proven SARS-CoV-2 infection. Participants were five years or older. Demographics and comorbidities were registered from participants above 17 years. RESULTS: Between June 15, 2021 and July 14, 2021, 454 individuals from the random sample participated, as well as 217 individuals with past SARS-CoV-2 infection. Mean time from positive PCR test result to antibody testing was 458.7 days (standard deviation 14.6 days) in the past infection group. In unvaccinated individuals, the seroconversion rate for S-IgG was 25.5% in the random sample and 75% in the past infection group (P = < 0.001). In vaccinated individuals, the mean signal ratios for S-IgG were higher in individuals with prior infection (6.9 vs 11.2; P = < 0.001). N-IgG were only detectable in 17.1% of participants with past infection. Predictors for detectable N-IgG were older age, male sex, fever, wheezing and in-hospital treatment for COVID-19 and cardiovascular comorbidities. CONCLUSION: N-IgG is not a reliable marker for SARS-CoV-2 infection after more than one year. In future, other diagnostic tests are needed to identify individuals with past natural infection.

The role of face masks within in-patient psychotherapy: Results of a survey among inpatients and healthcare professionals.

Introduction: Face-to-face medical and psychotherapeutic treatments during the Corona pandemic often involve patients and health care providers wearing face masks. We performed a pilot survey assessing the subjective experience of wearing face masks during psychotherapy sessions regarding (i) feasibility, (ii) psychotherapeutic treatment and (iii) communication, emotion and working alliance in patients and healthcare professionals. Methods: A total of n = 62 inpatients (RR = 95.4%) and n = 33 healthcare professionals (RR = 86.8%) at an academic department of Psychosomatic Medicine and Psychotherapy participated in this survey anonymously. The items of the questionnaire were created by the interprofessional expert team and were based on existing instruments: (i) the Therapeutic Relationship Questionnaire and (ii) the German translation of Yalom's Questionnaire on Experiencing in Group Psychotherapy. Results: The majority of patients rate their psychotherapy as highly profitable despite the mask. In individual therapy, face masks seem to have a rather low impact on subjective experience of psychotherapy and the relationship to the psychotherapist. Most patients reported using alternative facial expressions and expressions. In the interactional group therapy, masks were rather hindering. On the healthcare professional side, there were more frequent negative associations of face masks in relation to (i) experiencing connectedness with colleagues, (ii) forming relationships, and (iii) therapeutic treatment. Discussion: Information should be given to patients about the possible effects of face masks on the recognition of emotions, possible misinterpretations and compensation possibilities through alternative stimuli (e.g., eye area) and they should be encouraged to ask for further information. Especially in group therapy, with patients from other cultural backgrounds and in cases of need for help (e.g., hearing impairment) or complex disorders, appropriate non-verbal gestures and body language should be used to match the intended emotional expression.

The association of perceived leadership style and subjective well-being of employees in a tertiary hospital in Germany.

BACKGROUND: Professionals in the healthcare sector are a particularly vulnerable group for occupational strain due to high work-related psychological stress. For the implementation of targeted stress-prevention interventions as an important part of a workplace health management programme for all occupational groups and hierarchy levels, information about the current state of their mental health is mandatory. Hence, this study investigated the association of general well-being and different leadership styles among employees in a German tertiary hospital. METHODS: Via an online survey, 10,101 employees were contacted. The final sample consisted of 1137 employees. Of these, 27.7% described themselves as leaders and 72.3% as followers. Most participants were female (74.8%), more than half were under 41 years old. Besides control variables, general well-being (WHO-5) and leadership style (transactional and transformational, laissez-faire and destructive leadership) were assessed. RESULTS: Leaders reported higher well-being scores than followers. Physicians without leadership responsibilities had the lowest scores for well-being. Practitioners of both transformational and transactional leadership were associated with higher well-being scores, while those practicing laissez-faire and destructive leadership had lower scores for almost every professional group. CONCLUSION: Results highlight the necessity for future multimodal health-preventive leadership interventions feature behavioural and organizational intervention modules specifically tailored to hospital professionals at different hierarchical and functional levels to foster the mental health of employees.

Longitudinal development of depression and anxiety during COVID-19 pandemic in Germany: Findings from a population-based probability sample survey.

The stress response to the COVID-19 pandemic might differ between early and later stages. Longitudinal data on the development of population mental health during COVID-19 pandemic is scarce. We have investigated mental health trajectories and predictors for change in a probability sample of the general population in Germany at the beginning and after 6 months of the pandemic. We conducted a longitudinal survey in a population-based probability sample of German adults. The current study analyzed data from a first assessment in May 2020 (T1; N = 1,412) and a second in November 2020 (T2; N = 743). Mental health was assessed in terms of anxiety and depression using the Patient Health Questionnaire-4 (PHQ-4). Mental health outcomes at T1 were compared with PHQ-4 norm data. Trajectories over time were investigated based on outcome classifications of PHQ-4 scores. Predictors of mental health outcomes and change were identified using multiple regression analysis. In spring 2020, participants showed significantly higher PHQ-4 scores as compared to the norm data, however, overall anxiety and depression remained low also 6 months later. 6.6% of respondents showed a mental health deterioration in autumn 2020, entering subclinical and clinical ranges, outweighing the proportion of people with improved outcomes. Sociodemographic variables associated with mental distress at T1 were mainly not predictive for change at T2. Even under prolonged pandemic-related stress, mental health remained mainly stable in the general population. Further development of the considerable subgroup experiencing deterioration of depression and anxiety should be monitored, in order to tailor prevention and intervention efforts.

[Information about Eating Disorders - the perspective of relatives]. / Informationsbedarf bei Essstörungen ­ die Angehörigenperspektive.

Objectives: This qualitative study aimed to assess the need for information in eating disorders from the perspective of relatives. Further, it examined the question how publicly available information about eating disorders may contribute to psychoeducation. Methods: Thirteen relatives of patients with anorexia nervosa and bulimia nervosa were interviewed based on a semistructured interview guide. The interview transcripts were interpreted by using a structuring qualitative content analysis. Results: Relatives showed a high need for information throughout the entire course of illness. More information about the disorder itself and its potential treatment were requested. The needs were addressed to public services and to family doctors as well as paediatricians. Conclusions: Relatives as well as family doctors and paediatricians play an important role in the detection and support of the treatment of eating disorders. In view of the high rate of cases diagnosed late or not at all, psychoeducational offers require further expansion.

Impact of and Coping with Post-Traumatic Symptoms of Refugees in Temporary Accommodations in Germany: A Qualitative Analysis.

Due to pre-, peri- and post-migratory stress factors, refugees often experience higher levels of psychological stress than the general population. Post-traumatic stress disorder, in particular, has an increased prevalence in the refugee population. However, living conditions in the early post-migratory phase are characterized by many challenges. In the present qualitative study, 14 refugees with symptoms of PTSD from temporary accommodations in Germany were interviewed in semi-structured interviews about their individual experiences of the impact of their trauma sequelae symptoms on their current living conditions and interactions. Participants reported dealing with post-traumatic symptoms primarily through distraction strategies, such as working or learning the language or social interaction. Many reported a sense of mistrust as a result of traumatic experiences. Current stress factors cited included uncertain asylum status, worry about family members and lack of ability to influence living situations. The interactions between the post-traumatic symptoms and the living conditions of the refugees were highlighted. The effects of the symptomatology of trauma sequelae and the framework conditions under which refugees live can lead to aggravated psychological distress. Therefore, special attention must be paid to refugee mental health care.

The Unhappy Shoulder: A Conceptual Review of the Psychosomatics of Shoulder Pain.

INTRODUCTION: Chronic pain is a multifaceted disorder genuinely entangled with psychic and psychosomatic symptoms, which are typically involved in the processes of chronification. The impingement syndrome of the shoulder is no exception to this rule, but several studies have shown respective peculiarities among those with pain and impingement of the shoulder. Notably, chronic pain is a lateralized experience, and, similarly, its psychosomatic correlates may be attached to the hemispheres functionally. AIM: The present review therefore gives an overview of the respective findings, with regard not only to psychopathology, but also to personality factors and psychologic trauma, since the latter are reportedly associated with chronic pain. Moreover, we acknowledge symmetry as a possible pathogenic factor. METHODS: This narrative review followed the current standards for conducting narrative studies. Based on prior findings, our research strategy included the relevance of psychotraumatologic and symmetrical aspects, as well as comorbidity. We retrieved the relevant literature reporting on the impact of psychopathology as well as personality features on shoulder pain, as published up to January 2022 from the Medline database (1966-2022). Study selecton: We included numerous studies, and considered the contextual relevance of studies referring to the neuropsychosomatics of chronic pain. RESULTS: Pain-specific fears, depression, and anxiety are important predictors of shoulder pain, and the latter is generally overrepresented in those with trauma and PTSD. Moreover, associations of shoulder pain with psychological variables are stronger as regards surgical therapies as compared to conservative ones. This may point to a specific and possibly trauma-related vulnerability for perioperative maladaptation. Additionally, functional hemispheric lateralization may explain some of those results given that limb pain is a naturally lateralized experience. Not least, psychosocial risk factors are shared between shoulder pain and its physical comorbidities (e.g., hypertension), and the incapacitated state of the shoulder is a massive threat to the function of the human body as a whole. CONCLUSIONS: This review suggests the involvement of psychosomatic and psychotraumatologic factors in shoulder impingement-related chronic pain, but the inconclusiveness and heterogeneity of the literature in the field is possibly suggestive of other determinants such as laterality.

[Art therapy : Current developments in research and training]. / Kunsttherapie : Aktuelle Entwicklungen in Forschung und Ausbildung.

Art therapy is the intentional therapeutic use of the fine arts. Like music, dance, poetry and theater therapy, it is assigned to artistic therapy. This article provides an overview of general and recent developments as well as the state of the art in teaching in the discipline art therapy. Furthermore, two art therapeutic forms of intervention, the body outline image method (KUM) and Photo-Art-Therapy, are introduced. The aim is to further standardize the education and further training landscapes of art therapy, not least in order to further increase patient safety. This includes, for example, conveying systematically checked interventional measures and manuals that the students learn both theoretically and in the form of self-awareness. For about 10 years now, more and more high-impact quality research studies have been carried out Further evaluation studies in this field are desirable.

Supporting families to achieve a healthy weight development for their child with overweight/obesity using the STARKIDS intervention: study protocol for a cluster-randomized controlled trial.

BACKGROUND: Childhood and adolescent overweight and obesity are among the most serious health challenges today. Structured weight reduction programs can be helpful to reduce severe health consequences but evidence is partly scarce. The STARKIDS program aims to improve on some of these limitations and is designed to be a structured, stepwise, digitally supported intervention program for the whole family. It is divided into two intervention steps spanning over 1.5 years and aims at promoting a healthy weight development of children/adolescents with overweight/obesity and an increase in quality of life. METHODS: The STARKIDS intervention is evaluated in a cluster-randomized study design by comparing it with a control group receiving a one-time structured counselling in the pediatric practice. The study aims to include 1000 families with children/adolescents with overweight/obesity from 100 pediatric practices. The main outcomes are reduction in body mass index percentiles and improvements in children's/adolescent's quality of life, secondary outcomes refer to the contents of the intervention such as diet, physical activity, stress, and media habits. All outcomes are measured on three measurement time points: (T0) at baseline/inclusion in the study, (T1) baseline + 12 months which is the end of step 1 of the STARKIDS intervention, and (T2) baseline + 18 months which is the end of step 2 of the STARKIDS intervention. DISCUSSION: The stepwise, e-health-supported STARKIDS program is a low-threshold intervention program for families with children/adolescents with overweight/obesity. With the proof of concept, STARKIDS provides the potential to be implemented as a standard care tool for the prevention and intervention of childhood/adolescence obesity in the German health system. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00022813  (acknowledged primary register of the World Health Organization). Registered on 27 November 2020 (Universal Trial Number U1111-1254-9536).