Telemedical Coaching for Weight Loss (Fit)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephan Martin, West German Center of Diabetes and Health
ClinicalTrials.gov Identifier:
NCT01837134
First received: April 15, 2013
Last updated: May 28, 2014
Last verified: May 2014

April 15, 2013
May 28, 2014
May 2013
July 2013   (final data collection date for primary outcome measure)
weight loss [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Weight will be measured at baseline and after 12 weeks.
Same as current
Complete list of historical versions of study NCT01837134 on ClinicalTrials.gov Archive Site
  • cardiometabolic risk factors [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Quality of life will be assessed by the validated questionnaires ADS-L and SF-12.
  • physical activity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Physical activity will be assessed using a validated questionnaire.
Same as current
eating behaviour [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Eating behaviour will be measured using the validated questionnaire FEV.
Same as current
 
Telemedical Coaching for Weight Loss
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Overweight
  • Obesity
  • Metabolic Syndrome
  • Device: telemedical (TM) group
    telemedical devices (weighing machine and step counter)
  • Behavioral: telemedical coaching (TMC) group
    care calls once per week for 12 weeks
  • 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.
    Intervention: Device: telemedical (TM) group
  • 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.
    Interventions:
    • Device: telemedical (TM) group
    • Behavioral: telemedical coaching (TMC) group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2014
July 2013   (final data collection date for primary outcome measure)

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
Both
40 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01837134
Telemedical coaching, 98149
No
Stephan Martin, West German Center of Diabetes and Health
West German Center of Diabetes and Health
Not Provided
Principal Investigator: Stephan Martin, MD West-German Centre of Diabetes and Health
West German Center of Diabetes and Health
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP