Hypertension is one of the key factors causing cardiovascular diseases. A substantial proportion of treated hypertensive patients do not reach recommended target blood pressure values. Shared decision making (SDM) is to enhance the active role of patients. As until now there exists little information on the effects of SDM training in antihypertensive therapy, we tested the effect of an SDM training programme for general practitioners (GPs). Our hypotheses are that this SDM training (1) enhances the participation of patients and (2) leads to an enhanced decrease in blood pressure (BP) values, compared to patients receiving usual care without prior SDM training for GPs.

Background: The high proportion of people with overweight and obesity has become a worldwide problem in recent decades, mainly due to health consequences, such as cardiovascular diseases, neoplasia, and type 2 diabetes mellitus. Regarding effective countermeasures, the digitization of health services offers numerous potentials, which, however, have not yet been sufficiently evaluated. Web-based health programs are becoming increasingly interactive and can provide individuals with effective long-term weight management support. Objective: The purpose of this randomized controlled clinical trial was to evaluate the effectiveness of an interactive web-based weight loss program on anthropometric, cardiometabolic, and behavioral variables and to compare it with a noninteractive web-based weight loss program. Methods: The randomized controlled trial included people who were aged between 18 and 65 years (mean 48.92, SD 11.17 years) and had a BMI of 27.5 to 34.9 kg/m2 (mean 30.71, SD 2.13 kg/m2). Participants (n=153) were assigned to either (1) an interactive and fully automated web-based health program (intervention) or (2) a noninteractive web-based health program (control). The intervention program focused on dietary energy density and allowed for dietary documentation with appropriate feedback on energy density and nutrients. The control group only received information on weight loss and energy density, but the website did not contain interactive content. Examinations were performed at baseline (t0), at the end of the 12-week intervention (t1), and at 6 months (t2) and 12 months (t3) thereafter. The primary outcome was body weight. The secondary outcomes were cardiometabolic variables as well as dietary and physical activity behaviors. Robust linear mixed models were used to evaluate the primary and secondary outcomes. Results: The intervention group showed significant improvements in anthropometric variables, such as body weight (P=.004), waist circumference (P=.002), and fat mass (P=.02), compared with the control group over the course of the study. The mean weight loss after the 12-month follow-up was 4.18 kg (4.7%) in the intervention group versus 1.29 kg (1.5%) in the control group compared with the initial weight. The results of the nutritional analysis showed that the energy density concept was significantly better implemented in the intervention group. Significant differences in cardiometabolic variables were not detected between the 2 groups. Conclusions: The interactive web-based health program was effective in reducing body weight and improving body composition in adults with overweight and obesity. However, these improvements were not associated with relevant changes in cardiometabolic variables, although it should be noted that the study population was predominantly metabolically healthy. Trial Registration: German Clinical Trials Register DRKS00020249; https://drks.de/search/en/trial/DRKS00020249 International Registered Report Identifier (IRRID): RR2-10.3390/ijerph19031393

Depression is not a normal side effect of aging, however it is one of the most prevalent mental health issues in later life, imposing a tremendous burden on patients, their families, and the healthcare system. We describe the experimental implementation of a collaborative, stepped-care model for the treatment of late-life depression (GermanIMPACT trial) in the German primary care context. GermanIMPACT was developed as an adaptation of a successful and widely used American model. The aim of the study is to evaluate the model’s applicability to the German primary care setting and its cost-effectiveness. The study will be conducted as a cluster-randomized controlled trial comparing the development of depressive symptoms in primary care patients who either receive treatment as usual (control arm) or treatment according to the GermanIMPACT model (intervention arm). In two German cities (Freiburg and Hamburg), a total of 60 general practice offices will be selected and randomized. Each general practice office will be asked to enroll five patients into the trial who are 60 years of age or older and who show moderate depressive symptoms in the scope of a diagnosed depressive episode, recurrent depressive disorder, or dysthymia. General practices in the control arm will provide treatment as usual; general practices in the intervention arm will work closely with a specially trained care manager and a supervising mental health specialist. Evidence-based elements of the treatment plan manual include patient education, identification and integration of positive activities into the daily routine, relapse prevention, and training of problem-solving techniques as needed. The intervention period per patient will be one year. Data will be collected at baseline, 6, and 12 months. Primary outcome is the patient-reported change of depressive symptoms (Patient Health Questionnaire, PHQ-9). Secondary outcomes include measures of quality of life, anxiety, depression-related behavior, problem-solving skills, resilience, and an overall economic evaluation of the program. The GermanIMPACT trial will provide evidence about the effectiveness, feasibility, and cost-effectiveness of collaborative stepped care in treating late-life depression in German primary care. Positive results will be a first step toward integrating specialized depression care managers into the primary care setting. German Clinical Trials Register: DRKS00003589 (September 2012).

Web-based lifestyle interventions have attracted considerable research interest. Available evidence on such interventions suggests health-promoting effects, but further research is needed. Therefore, this study aims to investigate short-, medium-, and long-term health effects of a web-based health program (“TK-HealthCoach”, TK-HC) offered by a national statutory health insurance fund (Techniker Krankenkasse, TK). The study comprises two randomized controlled clinical trials to evaluate the health goals “Increasing Fitness” (F_clin) and “Losing and Maintaining Weight” (W_clin). A total of n = 186 physically inactive (F_clin) and n = 150 overweight or obese (W_clin) adults will be randomly assigned to a 12-week interactive (TK-HC) or non-interactive web-based health program using permuted block randomization with a 1:1 allocation ratio. Primary outcomes include cardiorespiratory fitness (F_clin) and body weight (W_clin). Secondary outcomes comprise musculoskeletal fitness (F_clin), physical activity and dietary behavior, anthropometry, blood pressure, blood levels, and vascular health (F_clin, W_clin). All outcomes will be measured before and after the 12-week intervention and after a 6- and 12-month follow-up. Additionally, usage behavior data on the health programs will be assessed. Linear mixed models (LMMs) will be used for statistical analysis. Findings of this study will expand the available evidence on web-based lifestyle interventions.

Personal behavior patterns, such as unhealthy diet and lack of physical activity, lead to the development of overweight and obesity. These are associated with other comorbidities, reduced quality of life, premature frailty and increased mortality. Personalized web-based interventions are promising in inducing behavioral change leading to effective reductions in body weight at relatively low costs. However, the long-term effects have not been thoroughly investigated. This work evaluates the effectiveness of web-based interactive weight loss coaching and compares it to a non-interactive web-based health program. Therefore, a randomized controlled trial (RCT) was implemented, measuring primary and secondary outcomes at four time points (program start; end of the 12-week-program; 6 months after program end, 12 months after program end). The net sample covered 1499 subjects in the intervention group and 1492 in the control group. On average, the IG was 43 years old (±13.6), 80.1% male, and had 86.4 kg body weight (±16.1) at baseline. The CG was 42.7 years old (±13.9), 79.5% male and had a mean body weight of 86.1 (±15.7). Multilevel analyses with fixed effects were carried out both from the perspective of an intention-to-treat (ITT) and a complete cases approach (CCA). In sum, our adjusted models suggest a weight loss of 0.4 kg per time point. At the end of the program, significant differences in weight loss in % to baseline (delta M = 1.8 in the CCA) were observed in favor of the intervention group. From a long-term perspective, no superiority of the intervention group in comparison to the control group could be found. More intensive use of the program was not statistically associated with higher weight loss.

Background: A healthy lifestyle can help prevent diseases that impair quality of life and lead to premature death. The Techniker health insurance fund offers a comprehensive online health program to support users in achieving their health goals of Increasing Fitness, Losing and Maintaining Weight, or Smoking Cessation. Methods: The aim of this study is to test the long-term effectiveness of the web-based TK-HealthCoach with regard to the primary outcomes of increased physical activity, sustainable weight reduction, and smoking abstinence. We are conducting three interconnected, randomized controlled trials (RCT), one for each health goal, within which participants are allocated to an intervention group (interactive online health program) or a control group (non-interactive online health program). The effects of the intervention groups compared to the control groups will be analyzed by multi-level models for change. Participants’ data are captured via online questionnaires before the program starts (baseline t0), again when it ends (t1), and later at two follow-up surveys (t2 and t3); the latter 12 months after t1. We are documenting socio-demographic, health-related, and psychological variables as well as usage behavior data of the programs. According to our sample size calculation, we have to enroll 1114 participants in each Losing and Maintaining Weight and Increasing Fitness RCT and 339 participants in the Smoking Cessation RCT. Additionally, 15–20 participants in the interactive smoking-cessation program will be invited to qualitative telephone interviews with the aim to obtain detailed information concerning utilization, compliance, and satisfaction. The online RCTs’ inclusion criteria are: adults of each gender regardless of whether they are insured with Techniker health insurance fund. Persons with impairments or pre-existing conditions require a medical assessment as to whether the program is suitable for them. Specific exclusion criteria apply to each program/RCT. Discussion: We assume that study participants will improve their health behavior by using the offered online health programs and that each health goal’s intervention group will reveal advantages regarding the outcome variables compared to the control groups. Study enrollment started on January 1, 2020. Trial registration: German Clinical Trials Register, Universal Trial Number (UTN): U1111-1245-0273. Registered on 11 December 2019