TeleLifestyleCoaching for Weight Loss

Overweight Clinical Trial

— FitMeFit  

Official title:

TeleLifestyleCoaching Use of Telemedicine for Weight Loss and Care of Weight Associated Illnesses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868763
• Other study ID #: FitMeFit
• Status: Completed
• Phase: N/A
• First received: May 30, 2013
• Last updated: June 4, 2013
• Start date: August 2012
• Est. completion date: March 2013

Study information

• Verified date: June 2013
• Source: West German Center of Diabetes and Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Overweight
• Weight Loss

Intervention

Device:
• telemedical devices (weighing machine and step counter)

Behavioral:
• care calls once per week for 12 weeks

Locations

Country	Name	City	State
Germany	West-German Centre of Diabetes and Health	Düsseldorf

Sponsors (2)

Lead Sponsor	Collaborator
West German Center of Diabetes and Health	HMM Holding AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss	Weight will be measured at baseline and after 12 weeks	12 weeks	No
Secondary	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]	12 weeks	No