NCT01868763

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 was 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
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
Last Updated

June 6, 2013

Status Verified

June 1, 2013

Enrollment Period

4 months

First QC Date

May 30, 2013

Last Update Submit

June 4, 2013

Conditions

Keywords

telemedicinecoachinglifestyle changeweight loss

Outcome Measures

Primary Outcomes (1)

  • weight loss

    Weight will be measured at baseline and after 12 weeks

    12 weeks

Secondary Outcomes (1)

  • cardiometabolic risk factors

    12 weeks

Study Arms (3)

control (C) group

NO INTERVENTION

The control group will remain in routine care for 12 weeks.

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 devices (weighing machine and step counter)

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.

Device: telemedical devices (weighing machine and step counter)Behavioral: care calls once per week for 12 weeks

Interventions

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≥27 kg/m2

You may not qualify if:

  • 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

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, 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.

MeSH Terms

Conditions

OverweightWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

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
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 30, 2013

First Posted

June 5, 2013

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

June 6, 2013

Record last verified: 2013-06

Locations