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

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

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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