ClinicalTrials.gov
ClinicalTrials.gov Menu

Telemedical Coaching for Weight Loss (Fit)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01837134
Recruitment Status : Completed
First Posted : April 22, 2013
Last Update Posted : May 29, 2014
Sponsor:
Information provided by (Responsible Party):
Stephan Martin, West German Center of Diabetes and Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Metabolic Syndrome Device: telemedical (TM) group Behavioral: telemedical coaching (TMC) group Not Applicable

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: TeleLifestyleCoaching Study - Telemedical Coaching for Weight Loss
Study Start Date : May 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 (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.
Device: telemedical (TM) group
telemedical devices (weighing machine and step counter)

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.
Device: telemedical (TM) group
telemedical devices (weighing machine and step counter)

Behavioral: telemedical coaching (TMC) group
care calls once per week for 12 weeks




Primary Outcome Measures :
  1. weight loss [ Time Frame: 12 weeks ]
    Weight will be measured at baseline and after 12 weeks.


Secondary Outcome Measures :
  1. cardiometabolic risk factors [ Time Frame: 12 weeks ]
  2. quality of life [ Time Frame: 12 weeks ]
    Quality of life will be assessed by the validated questionnaires ADS-L and SF-12.

  3. physical activity [ Time Frame: 12 weeks ]
    Physical activity will be assessed using a validated questionnaire.


Other Outcome Measures:
  1. eating behaviour [ Time Frame: 12 weeks ]
    Eating behaviour will be measured using the validated questionnaire FEV.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837134


Locations
Germany
West-German Centre of Diabetes and Health
Düsseldorf, Germany, 40591
Sponsors and Collaborators
West German Center of Diabetes and Health
Investigators
Principal Investigator: Stephan Martin, MD West-German Centre of Diabetes and Health

Responsible Party: Stephan Martin, Director of the West German Center of Diabetes and Health, West German Center of Diabetes and Health
ClinicalTrials.gov Identifier: NCT01837134     History of Changes
Other Study ID Numbers: Telemedical coaching
98149 ( Other Grant/Funding Number: Boehringer Ingelheim Pharma GmbH & Co.KG )
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014

Keywords provided by Stephan Martin, West German Center of Diabetes and Health:
telemedicine
overweight
obesity

Additional relevant MeSH terms:
Overweight
Weight Loss
Metabolic Syndrome X
Body Weight
Signs and Symptoms
Body Weight Changes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases