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Clinical Trials/NCT01634204
NCT01634204
Unknown
Phase 2

Is the Support of a Web-based Weight Loss Program Effective in Supporting Self-initiated Weight Loss and Lifestyle Changes?

Charite University, Berlin, Germany3 sites in 2 countries84 target enrollmentSeptember 2011
ConditionsOverweightObese

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Overweight
Sponsor
Charite University, Berlin, Germany
Enrollment
84
Locations
3
Primary Endpoint
body weight reduction in %
Last Updated
13 years ago

Overview

Brief Summary

Since overweight and obesity, a risk factor for various diseases, is a prevalent problem in the modern society, it is important to search for new strategies to counteract this. In contrast to in person support, the internet provides a low cost opportunity, which is able to reach a large part of the population. Therefore a web-based weight loss program may be an adequate mean for many people. Now it is hypothesised that a web-based weight loss program is able to support a reduction of body weight and weight-related cardiovascular risk factors effectively and to promote a healthier lifestyle. It is expected that program use, compared to a control group, results in greater reductions in body weight and cardiovascular risk.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
July 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Luzia Valentini

Dr. rer. nat.

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

  • age 30-65 years
  • body Mass Index: 27-39,9 kg/m2
  • ECOG-Performance status degree 0 or 1
  • basal internet skills
  • private internet access
  • signed informed consent

Exclusion Criteria

  • malign diseases
  • major organ diseases
  • inflammatory bowel diseases
  • insulin - dependent diabetes mellitus
  • pregnancy, breast feeding
  • treatment of eating disorders (e.g. bulimia, anorexia nervosa) within past 5 years
  • parallel participation in other weight loss programs or other trials
  • weight loss \> 5% within past 6 month
  • chronic therapy with glucocorticoids
  • subjects treated because of psychiatric disorders (e.g. schizophrenia, bipolar disorder) in the past

Outcomes

Primary Outcomes

body weight reduction in %

Time Frame: after 3 months

Secondary Outcomes

  • body weight reduction in %(after 6 and 12 months)
  • cardiovascular risk(after 3,6 and 12 months)
  • Quality of life(after 3,6 and 12 months)
  • Nutrition and physical activity(after 3,6 and 12 months)

Study Sites (3)

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