Telemedical Coaching for Weight Loss

Study Overview
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Brief Summary
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Lifestyle changes often fail due to loss of motivation. Telemedicine and personal coaching have the potential to support lifestyle change and weight loss. Therefore, the aim of our randomized controlled trial is to examine the effect of telemedicine with and without coaching in comparison to a control group on weight loss in overweight participants.

Detailed Description
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In an occupational health care setting employees with overweight and/or metabolic syndrome will be randomized into a three arm 12-week trial. Participants in the telemedical (TM) and telemedical coaching (TMC) group got a weighing machine and a step counter, with automatic transfer into a personalized online portal, which could be monitored from both, the participant and the study centre. The TMC group weekly will get care calls from the study centre aiming to discuss measured data and to fix target agreements. The control group will remain in routine care.

Official Title
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TeleLifestyleCoaching Study - Telemedical Coaching for Weight Loss

Conditions
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Overweight, Obesity, Metabolic Syndrome

Intervention / Treatment
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* Device: telemedical (TM) group
* Behavioral: telemedical coaching (TMC) group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: employed at Boehringer Ingelheim Pharma GmbH for at least 2 years older than 40 years overweight or obese or metabolic syndrome Exclusion Criteria: not willing to participate

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control (C) group<br>The control group will remain in routine care for 12 weeks. After 12 weeks they will also be given a weighing machine and a step counter, with automatic transfer into a personalized online portal, which can be monitored from both, the participant and the study centre. During the next 12 weeks they will get care calls from the study centre aiming to discuss measured data and to fix target agreements. | |
| Experimental: telemedical (TM) group<br>Participants in the telemedical (TM) group will get a weighing machine and a step counter, with automatic transfer into a personalized online portal, which can be monitored from both, the participant and the study centre. | Device: telemedical (TM) group<br>* telemedical devices (weighing machine and step counter)<br>|
| Experimental: telemedical coaching (TMC) group<br>Participants in the telemedical coaching (TMC) group will get a weighing machine and a step counter, with automatic transfer into a personalized online portal, which can be monitored from both, the participant and the study centre. Additionally, they will be called once per week for 12 weeks from the study centre aiming to discuss measured data and to fix target agreements. After 12 weeks the care calls be be given once per month for further 9 months. | Device: telemedical (TM) group<br>* telemedical devices (weighing machine and step counter)<br>Behavioral: telemedical coaching (TMC) group<br>* care calls once per week for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss | Weight will be measured at baseline and after 12 weeks. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiometabolic risk factors |  | 12 weeks | 
| quality of life | Quality of life will be assessed by the validated questionnaires ADS-L and SF-12. | 12 weeks | 
| physical activity | Physical activity will be assessed using a validated questionnaire. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine, overweight, obesity