Tinsel, Iris http://orcid.org/0000-0001-8689-9982
Metzner, Gloria
Schlett, Christian
Sehlbrede, Matthias
Bischoff, Martina
Anger, Robin
Brame, Judith
König, Daniel
Wurst, Ramona
Fuchs, Reinhard
Lindinger, Peter
Bredenkamp, Rainer
Farin-Glattacker, Erik
Funding for this research was provided by:
The Techniker health insurance fund
Universitätsklinikum Freiburg
Article History
Received: 31 August 2020
Accepted: 20 July 2021
First Online: 10 August 2021
Change Date: 28 October 2021
Change Type: Update
Change Details: The article's Funding section has been updated.
Declarations
:
: According to the ethics guidelines and European General Data Protection Regulation, participants have to give informed consent to participate in the study.Informed consent: Before registering in the online study and health program, all interested persons must actively confirm (by ticking a checkbox) that they meet the conditions for participation in the program, have read the study information, and agree to the conditions. Finally, they must actively agree to participate in the study. Participants can download and/or print out the study information and declaration of consent immediately and/or later. Persons who unsubscribe from the health program or the study will receive an e-mail with a link to download the study information and declaration of consent.Data protection for the study participants is guaranteed in accordance with the European General Data Protection Regulation (GDPR). Staff members involved in the project are committed to such data protection through their institutions.A data protection concept was drawn up for this project which was approved by the data protection officer of the Medical Center – University of Freiburg. This data protection concept includes a Joint Controller Agreement (JCA) that has been accepted by the data protection officers of all project partners involved and signed at the highest management level in those institutions.All personal data on the participants in the online RCTs will be stored and recorded separately from pseudonymized research data by the Vilua healthcare GmbH. Vilua will share only pseudonymized or aggregated research data to the SEVERA and the IfSS. One exception concerns contact details on participants in the RCT <i>Smoking Cessation</i> who registered for a telephone interview, which will be executed by SEVERA. This will affect approximately 15–20 people in the intervention group. A further access to contact details of a limited number of participants is necessary as part of the medical substudies, since the examinations are organized and carried out by the IfSS (details will be published elsewhere).All participants can withdraw from their study participation or from the online health program at any time without any disadvantages. Their personal data will be deleted immediately. The research data collected up to that point will remain anonymous. No further data will be recorded.Persons can withdraw from the study participation but still continue to engage in their specific health program. In this case, research data is no longer collected and recorded research data will be anonymized.All surveyed data will be anonymized 3 years after study completion and completely deleted teen years after the publication of the study results.
: Participation in the online studies and the online health programs are not expected to cause harms or risks—especially considering the inclusion and exclusion criteria with which the users have to agree. If participants have any questions or feel uncomfortable, they can always contact the program's customer service or the study contact persons. All inquiries and possible health problems will be logged. In case of health problems, the principal medical doctor of the study (Prof. Dr. med. D. König) will be informed. The procedure for dealing with very unlikely but possible risks during the medical examinations in the two substudies has been approved by the Ethics Committee Freiburg and will be published elsewhere.
: The main results of studies concerning the effectiveness of health programs are to be published in scientific journals. These publications will be prepared under the leadership of SEVERA, which, as the main institution responsible for evaluation, will also be responsible for data analysis. The other scientific project participants will be involved in these publications. All scientific project participants aim to publish further publications on questions of interest, for which appropriate authorships will be determined according to the usual rules.
: This study received a favorable opinion from the ethics commission of Albert-Ludwigs University, Medical Center, Freiburg (vote no. 237/19) on 25 July 2019. Based on results of a feasibility study (ethics approval No 40918, study registration in the German Clinical Trial Register DRKS-ID: DRKS00016512), an amendment with minor modification to the study protocol was rational and positively judged by the ethics commission of Albert-Ludwigs University, Medical Center, Freiburg on 22 October 2019.Trial registration: This study is registered in the German Clinical Trials Register ExternalRef removed with the registry ID DRKS00020249 at 11 December 2019. The universal Trial Number (UTN) is: U1111-1245-0273; International Clinical Trials Registry Platform ExternalRef removedRecruiting of participants started 1 January 2020.If, contrary to expectations, changes to the protocol were required, the following process would be initiated: amendment of the study protocol and submission to the Ethics Committee for approval, participants to be informed via the program website and by Vilua via email. To inform researchers, we would amend entries in the German Clinical Trials Register (DRKS). Finally, we would ask the editors of “BMC trials” to publicize a correction, linked to the original study protocol.
: Not applicable
: The <i>Techniker health insurance fund</i> contracted SEVERA to plan and coordinate this overall study and to carry out the online RCTs, as well as to conduct the formative evaluation of the <i>SmokingCessationCoaching</i> via qualitative interviews and analyses of the usage behavior data. On the basis of the declaration of independent scientific study implementation and publication by the <i>Techniker</i>, IT, GM, CS, MS, MB, RA, and EF declare that they have no conflicts of interest.JB, DK, RW, and RF (IfSS) declare that (a) the formative and summative evaluation of the <i>TK-HealthCoach</i> (the <i>Increasing Fitness</i> and <i>Losing and Maintaining Weight</i> health goals) is supported by the <i>TK</i>, that (b) content-related advice on the further development of the <i>Increasing Fitness</i> and <i>Losing and Maintaining Weight</i> health goals is supported by the <i>TK</i>, and that (c) the publication of the evaluation results will be supported by the <i>TK</i> by their covering the publication fees of the respective journals. For the aforementioned topics (a) and (b), travel expenses are included. There are no other conflicts of interest.