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

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

      • 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

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.
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

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.

Clinical Trials on Overweight

Clinical Trials on telemedical devices (weighing machine and step counter)

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