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TeleLifestyleCoaching for Weight Loss (FitMeFit)

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
telemedical devices (weighing machine and step counter)
care calls once per week for 12 weeks
Sponsored by
West German Center of Diabetes and Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight focused on measuring telemedicine, coaching, lifestyle change, weight loss

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • West-German Centre of Diabetes and Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control (C) group

telemedical (TM) group

telemedical coaching (TMC) group

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

weight loss
Weight will be measured at baseline and after 12 weeks

Secondary Outcome Measures

cardiometabolic risk factors
Body mass index [kg/m2], waist circumference [cm], blood pressure [mmHg], triglycerides [mg/dl], HbA1c [%], total, HDL and LDL cholesterol [mg/dl]

Full Information

First Posted
May 30, 2013
Last Updated
June 4, 2013
Sponsor
West German Center of Diabetes and Health
Collaborators
HMM Holding AG
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1. Study Identification

Unique Protocol Identification Number
NCT01868763
Brief Title
TeleLifestyleCoaching for Weight Loss
Acronym
FitMeFit
Official Title
TeleLifestyleCoaching Use of Telemedicine for Weight Loss and Care of Weight Associated Illnesses
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West German Center of Diabetes and Health
Collaborators
HMM Holding AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
telemedicine, coaching, lifestyle change, weight loss

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control (C) group
Arm Type
No Intervention
Arm Description
The control group will remain in routine care for 12 weeks.
Arm Title
telemedical (TM) group
Arm Type
Experimental
Arm Description
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.
Arm Title
telemedical coaching (TMC) group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
telemedical devices (weighing machine and step counter)
Intervention Type
Behavioral
Intervention Name(s)
care calls once per week for 12 weeks
Primary Outcome Measure Information:
Title
weight loss
Description
Weight will be measured at baseline and after 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
cardiometabolic risk factors
Description
Body mass index [kg/m2], waist circumference [cm], blood pressure [mmHg], triglycerides [mg/dl], HbA1c [%], total, HDL and LDL cholesterol [mg/dl]
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Martin, MD
Organizational Affiliation
West-German Centre of Diabetes and Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
West-German Centre of Diabetes and Health
City
Düsseldorf
ZIP/Postal Code
40591
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
30271433
Citation
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.
Results Reference
derived

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TeleLifestyleCoaching for Weight Loss

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