Evaluation of the web-based HealthCoach of the Techniker health insurance fund

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00020249
• Date of registration: 11/12/2019
• Prospective Registration: Yes
• Primary sponsor: Institut für Medizinische Biometrie und Medizinische Informatik, Sektion Versorgungsforschung und Rehabilitationsforschung, Universitätsklinikum Freiburg
• Public title: Evaluation of the web-based HealthCoach of the Techniker health insurance fund
• Scientific title: Evaluation of the web-based HealthCoach of the Techniker health insurance fund - EVA-TK-Coach
• Date of first enrolment: 01/01/2020
• Target sample size: 2903
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00020249
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: parallel; Study design purpose: prevention
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Iris Tinsel
• Affiliation: Institut für Medizinische Biometrie und Statistik, Sektion Versorgungsforschung und Rehabilitationsforschung (SEVERA), Universitätsklinikum Freiburg

• Name: Erik Farin-Glattacker
• Affiliation: Institut für Medizinische Biometrie und Medizinische Informatik, Sektion Versorgungsforschung und Rehabilitationsforschung, Universitätsklinikum Freiburg

Key inclusion & exclusion criteria

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.


Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

Healthy volunteers with physical inactivity. Healthy volunteers with overweight, obesity Healthy volunteers smoking tobacco cigarettes

Intervention(s)

Group 1: Health goal "Increasing fitness" - Control group: 12-week non-interactive online health program to increase physical activity.
Group 2: Health goal "Increasing fitness" - Intervention group: 12-week interactive online health coach to increase physical activity.
Group 3: Health goal „Losing and maintaining weight” -
Control group: 12-week non-interactive online health program to reduce and subsequent weight maintenance.

Group 4: Health goal „Losing and maintaining weight” - Intervention group: 12-week interactive online health coach to reduce and subsequent weight maintenance.

Group 5: Health goal “Smoking cessation” - Control group: 12-week non-interactive online health program to reach the smoke abstinence.

Group 6: Health goal “Smoking cessation” - Intervention group: 12-week interactive online health coach to reach the smoke abstinence.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

U1111-1245-0273

Source(s) of Monetary Support

Techniker Krankenkasse

Ethics review

Status: Approved
Approval date: 22/10/2019
Contact:

[e-mail]

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 06/02/2023
• URL: http://drks.de/search/en/trial/DRKS00020249#studyResults