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

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” (Fclin) and “Losing and Maintaining Weight” (Wclin). A total of n = 186 physically inactive (Fclin) and n = 150 overweight or obese (Wclin) 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 (Fclin) and body weight (Wclin). Secondary outcomes comprise musculoskeletal fitness (Fclin), physical activity and dietary behavior, anthropometry, blood pressure, blood levels, and vascular health (Fclin, Wclin). 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.

This is the first consensus SOP of the Centers of Excellence in Germany (certified by the German Cancer Aid) regarding diagnosis, treatment, and follow-up for malignant melanomas of the conjunctiva.

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