Telemedical Coaching for Weight Loss

NCT ID: NCT01837134

Last Updated: 2014-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-04-30

Brief Summary

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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

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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.

Conditions

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Overweight Obesity Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

telemedical (TM) group

Intervention Type DEVICE

telemedical devices (weighing machine and step counter)

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.

Group Type EXPERIMENTAL

telemedical (TM) group

Intervention Type DEVICE

telemedical devices (weighing machine and step counter)

telemedical coaching (TMC) group

Intervention Type BEHAVIORAL

care calls once per week for 12 weeks

Interventions

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telemedical (TM) group

telemedical devices (weighing machine and step counter)

Intervention Type DEVICE

telemedical coaching (TMC) group

care calls once per week for 12 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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West German Center of Diabetes and Health

OTHER

Sponsor Role lead

Responsible Party

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Stephan Martin

Director of the West German Center of Diabetes and Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephan Martin, MD

Role: PRINCIPAL_INVESTIGATOR

West-German Centre of Diabetes and Health

Locations

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West-German Centre of Diabetes and Health

Düsseldorf, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 30975666 (View on PubMed)

Other Identifiers

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98149

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Telemedical coaching

Identifier Type: -

Identifier Source: org_study_id

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