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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

Tracking Information
First Submitted Date  ICMJE April 15, 2013
First Posted Date  ICMJE April 22, 2013
Last Update Posted Date May 29, 2014
Study Start Date  ICMJE May 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
weight loss [ Time Frame: 12 weeks ]
Weight will be measured at baseline and after 12 weeks.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
  • cardiometabolic risk factors [ Time Frame: 12 weeks ]
  • quality of life [ Time Frame: 12 weeks ]
    Quality of life will be assessed by the validated questionnaires ADS-L and SF-12.
  • physical activity [ Time Frame: 12 weeks ]
    Physical activity will be assessed using a validated questionnaire.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 17, 2013)
eating behaviour [ Time Frame: 12 weeks ]
Eating behaviour will be measured using the validated questionnaire FEV.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Telemedical Coaching for Weight Loss
Official Title  ICMJE TeleLifestyleCoaching Study - Telemedical Coaching for Weight Loss
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Overweight
  • Obesity
  • Metabolic Syndrome
Intervention  ICMJE
  • Device: telemedical (TM) group
    telemedical devices (weighing machine and step counter)
  • Behavioral: telemedical coaching (TMC) group
    care calls once per week for 12 weeks
Study Arms  ICMJE
  • 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
Publications * Kempf K, Röhling M, Martin S, Schneider M. Telemedical coaching for weight loss in overweight employees: a three-armed randomised controlled trial. BMJ Open. 2019 Apr 11;9(4):e022242. doi: 10.1136/bmjopen-2018-022242. Erratum in: BMJ Open. 2019 May 29;9(5):e022242corr1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01837134
Other Study ID Numbers  ICMJE Telemedical coaching
98149 ( Other Grant/Funding Number: Boehringer Ingelheim Pharma GmbH & Co.KG )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephan Martin, West German Center of Diabetes and Health
Study Sponsor  ICMJE West German Center of Diabetes and Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephan Martin, MD West-German Centre of Diabetes and Health
PRS Account West German Center of Diabetes and Health
Verification Date May 2014

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