- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01837134
Telemedical Coaching for Weight Loss (Fit)
May 28, 2014 updated by: Stephan Martin, West German Center of Diabetes and Health
TeleLifestyleCoaching Study - Telemedical Coaching for Weight Loss
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Düsseldorf, Germany, 40591
- West-German Centre of Diabetes and Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: telemedical (TM) group
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.
|
telemedical devices (weighing machine and step counter)
|
No Intervention: control (C) group
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 coaching (TMC) group
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.
|
telemedical devices (weighing machine and step counter)
care calls once per week for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
weight loss
Time Frame: 12 weeks
|
Weight will be measured at baseline and after 12 weeks.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cardiometabolic risk factors
Time Frame: 12 weeks
|
12 weeks
|
|
quality of life
Time Frame: 12 weeks
|
Quality of life will be assessed by the validated questionnaires ADS-L and SF-12.
|
12 weeks
|
physical activity
Time Frame: 12 weeks
|
Physical activity will be assessed using a validated questionnaire.
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
eating behaviour
Time Frame: 12 weeks
|
Eating behaviour will be measured using the validated questionnaire FEV.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephan Martin, MD, West-German Centre of Diabetes and Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
April 15, 2013
First Submitted That Met QC Criteria
April 17, 2013
First Posted (Estimate)
April 22, 2013
Study Record Updates
Last Update Posted (Estimate)
May 29, 2014
Last Update Submitted That Met QC Criteria
May 28, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Telemedical coaching
- 98149 (Other Grant/Funding Number: Boehringer Ingelheim Pharma GmbH & Co.KG)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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