- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01868763
TeleLifestyleCoaching for Weight Loss (FitMeFit)
June 4, 2013 updated by: Stephan Martin, West German Center of Diabetes and Health
TeleLifestyleCoaching Use of Telemedicine for Weight Loss and Care of Weight Associated Illnesses
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 was 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
Detailed Description
In an occupational health care setting overweight employees were 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 got care calls from the study centre aiming to discuss measured data and to fix target agreements.
The control group remained in routine care.
Wilcoxon signed rank test was used to determine if differences (baseline vs. after 12 weeks) were significantly different from 0 and ANOVA test for determination of inter group differences.
Study Type
Interventional
Enrollment (Actual)
180
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
-
-
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Düsseldorf, Germany, 40591
- West-German Centre of Diabetes and Health
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-
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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI ≥27 kg/m2
Exclusion Criteria:
- Hypoglycemia inducing medication
- severe disease with hospital stay during the last 3 months
- smoking cessation for less then 3 months
- planned smoking cessation during study phase
- acute infects
- chronic diseases
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control (C) group
The control group will remain in routine care for 12 weeks.
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|
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.
|
|
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.
|
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
|
Body mass index [kg/m2], waist circumference [cm], blood pressure [mmHg], triglycerides [mg/dl], HbA1c [%], total, HDL and LDL cholesterol [mg/dl]
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
August 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
May 30, 2013
First Submitted That Met QC Criteria
May 30, 2013
First Posted (Estimate)
June 5, 2013
Study Record Updates
Last Update Posted (Estimate)
June 6, 2013
Last Update Submitted That Met QC Criteria
June 4, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FitMeFit
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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