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Telemedical Coaching for Weight Loss (Fit)

Primary Purpose

Overweight, Obesity, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
telemedical (TM) group
telemedical coaching (TMC) group
Sponsored by
West German Center of Diabetes and Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring telemedicine, overweight, obesity

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • West-German Centre of Diabetes and Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control (C) group

telemedical (TM) group

telemedical coaching (TMC) group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

weight loss
Weight will be measured at baseline and after 12 weeks.

Secondary Outcome Measures

cardiometabolic risk factors
quality of life
Quality of life will be assessed by the validated questionnaires ADS-L and SF-12.
physical activity
Physical activity will be assessed using a validated questionnaire.

Full Information

First Posted
April 15, 2013
Last Updated
May 28, 2014
Sponsor
West German Center of Diabetes and Health
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1. Study Identification

Unique Protocol Identification Number
NCT01837134
Brief Title
Telemedical Coaching for Weight Loss
Acronym
Fit
Official Title
TeleLifestyleCoaching Study - Telemedical Coaching for Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West German Center of Diabetes and Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Metabolic Syndrome
Keywords
telemedicine, overweight, obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control (C) group
Arm Type
No Intervention
Arm Description
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.
Arm Title
telemedical (TM) group
Arm Type
Experimental
Arm Description
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.
Arm Title
telemedical coaching (TMC) group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
telemedical (TM) group
Intervention Description
telemedical devices (weighing machine and step counter)
Intervention Type
Behavioral
Intervention Name(s)
telemedical coaching (TMC) group
Intervention Description
care calls once per week for 12 weeks
Primary Outcome Measure Information:
Title
weight loss
Description
Weight will be measured at baseline and after 12 weeks.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
cardiometabolic risk factors
Time Frame
12 weeks
Title
quality of life
Description
Quality of life will be assessed by the validated questionnaires ADS-L and SF-12.
Time Frame
12 weeks
Title
physical activity
Description
Physical activity will be assessed using a validated questionnaire.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
eating behaviour
Description
Eating behaviour will be measured using the validated questionnaire FEV.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Martin, MD
Organizational Affiliation
West-German Centre of Diabetes and Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
West-German Centre of Diabetes and Health
City
Düsseldorf
ZIP/Postal Code
40591
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
30975666
Citation
Kempf K, Rohling 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.
Results Reference
derived

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Telemedical Coaching for Weight Loss

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