Effectiveness of an interactive web-based health program for adults: a study protocol for three concurrent controlled-randomized trials (EVA-TK-Coach)

Trials

Rainer Bredenkamp¹  Judith Brame²  Reinhard Fuchs²  Daniel König²  Ramona Wurst²  Peter Lindinger³  Matthias Sehlbrede⁴  Martina Bischoff⁴  Gloria Metzner⁴  Iris Tinsel⁴  Christian Schlett⁴  Erik Farin-Glattacker⁴  Robin Anger⁴ 

[1] Clinical Trials Unit UMG, University Medical Center Göttingen, Georg-August-University, Göttingen, Germany;Department of Sport and Sport Science (IfSS), University of Freiburg, Freiburg, Germany;Scientific Working Group in Smoking Cessation (WAT), Tübingen, Germany;Section of Health Care Research and Rehabilitation Research (SEVERA), Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Hugstetter Straße 49, 79106, Freiburg, Germany;

关键词: Primary prevention;    Health behavior;    Healthy lifestyle;    Smoking cessation;    Physical fitness;    Weight loss;    Randomized controlled trial;    Internet based intervention;    Web-based health program;    Behavior change;   

DOI  :  10.1186/s13063-021-05470-8

来源: Springer

【 摘 要 】

BackgroundA 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.MethodsThe 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.DiscussionWe 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 registrationGerman Clinical Trials Register, Universal Trial Number (UTN): U1111-1245-0273. Registered on 11 December 2019

【 授权许可】

CC BY