Telemedical Coaching for Weight Loss

Obesity Clinical Trial

— Fit  

Official title:

TeleLifestyleCoaching Study - Telemedical Coaching for Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837134
• Other study ID #: Telemedical coaching
• Secondary ID: 98149
• Status: Completed
• Phase: N/A
• First received: April 15, 2013
• Last updated: May 28, 2014
• Start date: May 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: West German Center of Diabetes and Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Overweight

Intervention

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

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

Locations

Country	Name	City	State
Germany	West-German Centre of Diabetes and Health	Düsseldorf

Sponsors (1)

Lead Sponsor	Collaborator
West German Center of Diabetes and Health

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	eating behaviour	Eating behaviour will be measured using the validated questionnaire FEV.	12 weeks	No
Primary	weight loss	Weight will be measured at baseline and after 12 weeks.	12 weeks	No
Secondary	cardiometabolic risk factors		12 weeks	No
Secondary	quality of life	Quality of life will be assessed by the validated questionnaires ADS-L and SF-12.	12 weeks	No
Secondary	physical activity	Physical activity will be assessed using a validated questionnaire.	12 weeks	No