TeleLifestyleCoaching for Weight Loss

NCT ID: NCT01868763

Last Updated: 2013-06-06

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

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-03-31

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 was 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 overweight employees were 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 got care calls from the study centre aiming to discuss measured data and to fix target agreements. The control group remained in routine care. Wilcoxon signed rank test was used to determine if differences (baseline vs. after 12 weeks) were significantly different from 0 and ANOVA test for determination of inter group differences.

Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

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.

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 devices (weighing machine and step counter)

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

telemedical devices (weighing machine and step counter)

Intervention Type DEVICE

care calls once per week for 12 weeks

Intervention Type BEHAVIORAL

Interventions

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telemedical devices (weighing machine and step counter)

Intervention Type DEVICE

care calls once per week for 12 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* BMI ≥27 kg/m2

Exclusion Criteria

* Hypoglycemia inducing medication
* severe disease with hospital stay during the last 3 months
* smoking cessation for less then 3 months
* planned smoking cessation during study phase
* acute infects
* chronic diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HMM Holding AG

UNKNOWN

Sponsor Role collaborator

West German Center of Diabetes and Health

OTHER

Sponsor Role lead

Responsible Party

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Stephan Martin

Director

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, Stichert M, Fischer G, Boschem E, Konner J, Martin S. Telemedical Coaching Improves Long-Term Weight Loss in Overweight Persons: A Randomized Controlled Trial. Int J Telemed Appl. 2018 Sep 9;2018:7530602. doi: 10.1155/2018/7530602. eCollection 2018.

Reference Type DERIVED
PMID: 30271433 (View on PubMed)

Other Identifiers

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FitMeFit

Identifier Type: -

Identifier Source: org_study_id

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