NCT01837134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2013

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

2 months

First QC Date

April 15, 2013

Last Update Submit

May 28, 2014

Conditions

OverweightObesityMetabolic Syndrome

Keywords

telemedicineoverweightobesity

Outcome Measures

Primary Outcomes (1)

  • weight loss

    Weight will be measured at baseline and after 12 weeks.

    12 weeks

Secondary Outcomes (3)

  • cardiometabolic risk factors

    12 weeks

  • quality of life

    12 weeks

  • physical activity

    12 weeks

Other Outcomes (1)

  • eating behaviour

    12 weeks

Study Arms (3)

control (C) group

NO INTERVENTION

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.

telemedical (TM) group

EXPERIMENTAL

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 coaching (TMC) group

EXPERIMENTAL

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) groupBehavioral: telemedical coaching (TMC) group

Interventions

telemedical (TM) groupDEVICE

telemedical devices (weighing machine and step counter)

telemedical (TM) grouptelemedical coaching (TMC) group
telemedical coaching (TMC) groupBEHAVIORAL

care calls once per week for 12 weeks

telemedical coaching (TMC) group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • employed at Boehringer Ingelheim Pharma GmbH for at least 2 years
  • older than 40 years
  • overweight or obese or metabolic syndrome

You may not qualify if:

  • not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West-German Centre of Diabetes and Health

Düsseldorf, 40591, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30975666DERIVED

MeSH Terms

Conditions

OverweightObesityMetabolic Syndrome

Interventions

Population Groups

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Stephan Martin, MD

    West-German Centre of Diabetes and Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the West German Center of Diabetes and Health

Study Record Dates

First Submitted

April 15, 2013

First Posted

April 22, 2013

Study Start

May 1, 2013

Primary Completion

July 1, 2013

Study Completion

April 1, 2014

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations

DE(1)