Evaluation of the web-based HealthCoach of the Techniker health insurance fund
Organizational Data
- DRKS-ID:
- DRKS00020249
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2019-12-11
- Last update in DRKS:
- 2024-01-15
- Registration type:
- Prospective
Acronym/abbreviation of the study
EVA-TK-Coach
URL of the study
No Entry
Brief summary in lay language
The Techniker (TK) health insurance fund offers a comprehensive online health coach to support users in achieving health goals such as “increasing fitness”, “losing and maintaining weight” or “quitting smoking”. The aim of this study is to scientifically test whether the "TK-HealthCoach” – a modern interactive online health program – helps to reduce the lifestyle-related risk factors of physical inactivity, overweight or smoking. To achieve this, the study participants will be randomly divided into two groups: the first group (control group) will have access to a classical, non-interactive online health program with information on the selected health goal; the second group (intervention group) will have access to the “TK HealthCoach”. To examine the effectiveness of the interactive program compared to the non-interactive program, study participants will receive a total of four online questionnaires containing questions on their health behavior and health status. The online surveys take place before the start and immediately after the end of the online health program, with follow-up surveys 4 to 6 months and 12 months after completion of the program. Study participants living in the postal code area 79 (South Baden) with the health goals of increasing fitness and losing and maintaining weight can, in addition to the online surveys, also take part in an accompanying medical study. At the University of Freiburg’s Department for Sports and Sport Science four medical examinations will be carried out. The aim is to analyze the impact of participation in the health programs on clinical parameters. In a second accompanying study, 15-20 participants will be invited to take part in telephone interviews. The aim of the interviews is to obtain detailed information concerning the utilization of and satisfaction with the interactive smoking cessation program. The online programs are available to healthy adults, regardless of whether or not they are insured with TK health insurance fund. Interested persons with impairments or pre-existing conditions require a medical assessment as to whether the program is suitable for them. Pregnant women are not allowed to participate in the fitness and weight loss programs.
Brief summary in scientific language
The ‘Techniker’ health insurance fund (TK) offers a comprehensive online health coach program to support users in achieving their health goals of increasing fitness, losing and maintaining weight or smoking cessation. The aim of this study is to test the long-term effectiveness of the TK HealthCoach with regard to the primary endpoints of increased physical activity, reduced weight and abstinence from smoking. In a randomized controlled trial design, participants are allocated to an intervention group (interactive online health program) or a control group (non-interactive online health program) within their health goal. Participant data is to be captured via online questionnaires at four time points: Baseline (t0), end-of-program (t1, after 6 or 12 weeks of runtime), 4 or 6 months after end-of-program (t2) and 12 months after end-of-program (t3). In the online questionnaires, self-reported data will be used to record socio-demographic, health-related and psychological variables. Study participants living in the postal code area 79 with the health goals of increasing fitness or losing and maintaining weight have the opportunity to take part in an accompanying medical study in addition to the online survey. At the University of Freiburg’s Department for Sports and Sport Science four medical examinations will be carried out in which various clinical parameters (will be assessed. The aim is to analyze the impact of participation in the health programs on clinical parameters. In another accompanying qualitative study, 15-20 participants will be invited to take part in semi-standardized telephone interviews. The aim of the interviews is to obtain detailed information concerning the utilization of and satisfaction with the interactive smoking cessation program. The inclusion criteria are: healthy persons aged 18 and over (male/female), regardless of whether or not they are insured with TK health insurance fund. Interested persons with impairments or pre-existing conditions require a medical assessment as to whether the program is suitable for them. Pregnant women are excluded from participation in the fitness and weight loss programs.
Health condition or problem studied
- Free text:
- Healthy volunteers with physical inactivity.
- Free text:
- Healthy volunteers with overweight, obesity
- Free text:
- Healthy volunteers smoking tobacco cigarettes
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Health goal "Increasing fitness" - Control group: 12-week non-interactive online health program to increase physical activity.
- Arm 2:
- Health goal "Increasing fitness" - Intervention group: 12-week interactive online health coach to increase physical activity.
- Arm 3:
- Health goal „Losing and maintaining weight” - Control group: 12-week non-interactive online health program to reduce and subsequent weight maintenance.
- Arm 4:
- Health goal „Losing and maintaining weight” - Intervention group: 12-week interactive online health coach to reduce and subsequent weight maintenance.
- Arm 5:
- Health goal “Smoking cessation” - Control group: 12-week non-interactive online health program to reach the smoke abstinence.
- Arm 6:
- Health goal “Smoking cessation” - Intervention group: 12-week interactive online health coach to reach the smoke abstinence.
Endpoints
- Primary outcome:
- 1) Health goal "Increasing fitness“ 1.1)Online Survey (self-reported): Change in exercise and sports activity (BSA-F3). 1.2) Medical study (assessed at the study center): maximum oxygen uptake (VO2max) (Cooper test). //The measurement times points for the health goal "increase fitness" are: t0: Baseline t1: After program completation, 12 weeks after t0 t2: 6 months after t1 t3: 12 months after t2. 2) Health goal "Losing and maintaining weight" 2.1) Online Survey (self-reported): change in weight( kg). 2.2) Medical study (assessed at the study center): change in body weight (kg; bioelectrical impedance analysis scale). //The measurement times points for the health goal "Losing and maintaining weight" are: t0: Baseline t1: After program completation, 12 weeks after t0 t2: 6 months after t1 t3: 12 months after t2. 3) Health goal "Smoking cessation" 3a) Online study (self-reported): Abstinence from smoking in the last 30 days (yes/no). //The measurement times points for the health goal "Smoking cessation" are: t0: Baseline t1: After program completation, 6 weeks after t0 t2: 4 months after t1 t3: 12 months after t2.
- Secondary outcome:
- 1) Health goal "Increasing fitness“ 1.1) Online survey (self-reported): Changes in goal intention (1 item, adapted), eating habits FEG (self-developed, Wurst et al. pub. in prep.), self-concordance (Seelig et al.), action planning (Sniehotta et al.), barrier management (Krämer et al.) and health status (SF-12; Morfeld et al.). 1.2) Medical study (assessed at the –University of Freiburg’s Department of Sport and Sport Science): (a) Physical fitness: change in the isometric maximum power (N) (leg force measuring plate, hand dynamometer). (b) Physical activity behavior: Change in steps/day taken (S/day), sedentary behaviour (min/day) and physical activity exercised (min/week) (Activity tracker Fitbit Charge 3TM, International Physical Activity Questionnnaire (long version)). (c) Nutritional behavior: Changes in energy and nutrient intake (kcal, μg/mg/g/%) and food consumption , (HEI-NVS) (ml/g, score) (NutriGuide®). (d) Anthropometry: changes in body weight (kg), body mass index (BMI,kg/m2), body composition (FFM, FM) (kg%) and abdominal girth (cm) (bioelectrical impedance analysis scale, measuring tape). (e) Blood pressure: changes in systolic and diastolic blood pressure (mmHg), (electronic blood pressure device). (f) Laboratory blood values: changes in total, LDL-, and HDL-cholesterol (mg/dl, mmol/l), triglycerides (mg/dl, mmol/l), fasting plasma glucose (mg/dl, mmol/l), and HbA1c (mmol/mol, %) (blood sampling). (g) Endothelial function: changes in flow mediating vasodilatation (FMD, FMD%) (Angio-Defender™ electronic system). //The measurement times points for the health goal "increase fitness" are: t0: Baseline t1: After program completation, 12 weeks after t0 t2: 6 months after t1 t3: 12 months after t2. 2) Health goal „losing and maintaining weight" 2.1) Online survey (self-reported): Changes in goal intention (1 item, adapted), in physical activity behavior (BSA-F3), eating habits (FEG self-development, Wurst et al.; pub in prep.), nutrition-specific self-efficacy (Ochsner et al.), consequence expectation (Renner et al.) and health status (SF-12; Morfeld et al.). 2.2) Medical study (assessed at the University of Freiburg’s Department of Sport and Sport Science): (a) Nutritional behavior: changes in Changes in energy and nutrient intake (kcal, μg/mg/g/%), and food consumption (HEI-NVS) (ml/g, score) and energy density (kcal/g) NutriGuide. (b) Physical activity behavior: Change in steps/day taken (S/day), sedentary behaviour (min/day) and physical activity exercised (min/week) (Activity tracker Fitbit Charge 3TM, International Physical Activity Questionnnaire (long version)). (c) Anthropometry: Changes in body mass index (BMI,kg/m2), body composition (FFM, FM) (kg%) and abdominal girth (cm) (bioelectrical impedance analysis scale), measuring tape). (d) Blood pressure: Changes in systolic and diastolic blood pressure (mmHg) (electronic blood pressure device). (e) Laboratory blood values: changes in total, LDL-, and HDL-cholesterol (mg/dl, mmol/l), triglycerides (mg/dl, mmol/l), fasting plasma glucose (mg/dl, mmol/l), HbA1c (mmol/mol, %) (Blood sampling). (f) Endothelial function: Changes in flow mediating vasodilatation (FMD, FMD%) (Angio-Defender™ electronic system). //The measurement times points for the health goal "Losing and maintaining weight" are: t0: Baseline t1: After program completation, 12 weeks after t0 t2: 6 months after t1 t3: 12 months after t2. 3) Health goal „Smoking cessation” 3.1) Online survey/self-reported): changes in goal intention (1 item; adapted); cigarette dependence (Fagerstrom), risk perception (Popova), self-efficacy (source, adapted), consequence expectation (Renner et al) and health status (SF-12; Morfeld et al). //The measurement times points for the health goal "Smoking cessation" are: t0: Baseline t1: After program completation, 6 weeks after t0 t2: 4 months after t1 t3: 12 months after t2.
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Other
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other Vilua healthcare GmbH Berlin
Recruitment period and number of participants
- Planned study start date:
- 2020-01-01
- Actual study start date:
- 2020-01-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 2903
- Final Sample Size:
- 6881
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- •In general: Healthy adults, regardless of whether or not they are insured with the Techniker health insurance fund. In the case of pre-existing conditions, a medical assessment is required in order to be able to participate in the health program. •For the medical studies: participation in the online survey, place of residence in the postal code area 79; participation in the medical examinations at the University of Freiburg’s Department for Sport and Sports Science at the (IfSS). •For the health goal of "Smoking Cessation”: regular smoking of cigarettes •Precondition for participation in a telephone interview with the health goal "Smoking Cessation" is the completion of the online questionnaire at the measuring time point t1. The persons must be reachable by telephone in the daytime. •The precondition for participation in the online survey and the corresponding partial studies is the agreement with the respective study information through the active confirmation of the informed consent.
Exclusion Criteria
In general: Participation in other studies aimed at changing behavior towards the health goals mentioned. 1) Health goal “Increasing fitness” 1.1) Online Survey: pregnancy 1.2) Medical study: pregnancy, > 65 years; BMI <18,5 kg/m2 or ≥35 kg/m2; sports activity > 60 min/week 2) Health goal „Losing and maintaining weight“ 2.1) Online Survey: pregnancy, breastfeeding period, severe obesity BMI > 40 kg/m2, abdominal girth > 200 cm; existing underweight or resulting underweight if, after a weight loss of 3 kg, a weight below the recommended normal weight would be reached. 2.2) Medical study: pregnancy, breastfeeding period; > 65 years; BMI < 27,5 kg/m2 or ≥ 35kg/m2, abdominal girth > 200 cm. 3) Telephone interviews of persons with the health goal „Smoking cessation“: Restrictions that do not allow a telephone interview, such as severe communication difficulties.
Addresses
Primary Sponsor
- Address:
- Institut für Medizinische Biometrie und Medizinische Informatik, Sektion Versorgungsforschung und Rehabilitationsforschung, Universitätsklinikum FreiburgProf. Dr. phil. Dipl. Psychologe Erik Farin-GlattackerHugstetter Straße 4979106 FreiburgGermany
- Telephone:
- 49 761 270-74430
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.imbi.uni-freiburg.de/SEVERA
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institut für Medizinische Biometrie und Medizinische Informatik, Sektion Versorgungsforschung und Rehabilitationsforschung, Universitätsklinikum FreiburgProf. Dr. phil. Dipl. Psychologe Erik Farin-GlattackerHugstetter Straße 4979106 FreiburgGermany
- Telephone:
- 49 761 270-74430
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.imbi.uni-freiburg.de/SEVERA
Contact for Public Queries
- Address:
- Institut für Medizinische Biometrie und Statistik, Sektion Versorgungsforschung und Rehabilitationsforschung (SEVERA), Universitätsklinikum FreiburgM.A. Iris TinselHugstetter Staße 4979106 FreiburgGermany
- Telephone:
- +49 761 270 74420
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.imbi.uni-freiburg.de/SEVERA
Principal Investigator
- Address:
- Institut für Medizinische Biometrie und Medizinische Informatik, Sektion Versorgungsforschung und Rehabilitationsforschung, Universitätsklinikum FreiburgProf. Dr. phil. Dipl. Psychologe Erik Farin-GlattackerHugstetter Straße 4979106 FreiburgGermany
- Telephone:
- 49 761 270-74430
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.imbi.uni-freiburg.de/SEVERA
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Techniker KrankenkasseBramfelder Straße 14022305 HamburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.tk.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-05-10
- Ethics committee number:
- 237/19
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-10-22
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- It cannot currently be guaranteed that anonymized data may not be de-anonymized in the future on the basis of diverse data available on the Internet. Therefore the collected data remain under control, will be anonymized, and deleted 10 years after completion of the study.
Study protocol and other study documents
- Study protocols:
- Tinsel I, Metzner G, Schlett C, Sehlbrede M, Bischoff M, Anger R, Brame J, König D, Wurst R, Fuchs R, Lindinger P, Bredenkamp R, Farin-Glattacker E.: Effectiveness of an interactive web-based health program for adults: a study protocol for three concurrent controlled-randomized trials (EVA-TK-Coach). Trials. 2021 Aug 10;22(1):526. doi: 10.1186/s13063-021-05470-8. PMID: 34376228
- Brame J, Kohl J, Wurst R, Fuchs R, Tinsel I, Maiwald P, Fichtner U, Armbruster C, Bischoff M, Farin-Glattacker E, Lindinger P, Bredenkamp R, Gollhofer A, König D.: Health Effects of a 12-Week Web-Based Lifestyle Intervention for Physically Inactive and Overweight or Obese Adults: Study Protocol of Two Randomized Controlled Clinical Trials. Int J Environ Res Public Health. 2022 Jan 26;19(3):1393. doi: 10.3390/ijerph19031393. PMID: 35162416
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Fichtner UA, Armbruster C, Bischoff M, Maiwald P, Sehlbrede M, Tinsel I, Brame J, Kohl J, König D, Fuchs R, Wurst R, Farin-Glattacker E.: Evaluation of an Interactive Web-Based Health Program for Weight Loss-A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Nov 17;19(22):15157. doi: 10.3390/ijerph192215157. PMID: 36429876
- Kohl J, Brame J, Hauff P, Wurst R, Sehlbrede M, Fichtner UA, Armbruster C, Tinsel I, Maiwald P, Farin-Glattacker E, Fuchs R, Gollhofer A, König D.: Effects of a Web-Based Weight Loss Program on the Healthy Eating Index-NVS in Adults with Overweight or Obesity and the Association with Dietary, Anthropometric and Cardiometabolic Variables: A Randomized Controlled Clinical Trial. Nutrients. 2022 Dec 20;15(1):7. doi: 10.3390/nu15010007. PMID: 36615666.
- Maiwald P, Bischoff M, Lindinger P, Tinsel I, Sehlbrede M, Fichtner UA, Metzner G, Schlett C, Farin-Glattacker E.: The Effect of Interactivity, Tailoring, and Use Intensity on the Effectiveness of an Internet-Based Smoking Cessation Intervention Over a 12-Month Period: Randomized Controlled Trial
- Maiwald P, Lindinger P, tinsel I, Fichtern UA, Farin-Glattacker E, Bischoff M.: [Evaluation of an eHealth Intervention for Smoking Cessation – a Qualitative Analysis on Satisfaction and User Impressions]
- Date of first publication of study results:
- 2022-11-22
- DRKS entry published for the first time with results:
- 2023-02-06
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry