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
  Purpose

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 Intervention
Overweight
Obesity
Metabolic Syndrome
Device: telemedical (TM) group
Behavioral: telemedical coaching (TMC) group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: TeleLifestyleCoaching Study - Telemedical Coaching for Weight Loss

Resource links provided by NLM:


Further study details as provided by West German Center of Diabetes and Health:

Primary Outcome Measures:
  • weight loss [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Weight will be measured at baseline and after 12 weeks.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • eating behaviour [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Eating behaviour will be measured using the validated questionnaire FEV.


Enrollment: 100
Study Start Date: May 2013
Study Completion Date: April 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: April 15, 2013
Last Updated: May 28, 2014
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on August 01, 2014