Clinical trial NCT01634204: Efficacy of a Web-based Weight Loss Program
Official title: Is the Support of a Web-based Weight Loss Program Effective in Supporting Self-initiated Weight Loss and Lifestyle Changes?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Overweight
Obese
Keywords: weight reduction
web-based intervention
cost-effective
overweight
obesity
cardiovascular risk
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: KiloCoach e.U.
name: University Hospital Regensburg
First posted: 2012-07-06
Enrollment: 84
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* subjects with expected non-compliance to protocol guidelines

Primary outcomes:
measure: body weight reduction in %
timeFrame: after 3 months
Secondary outcomes:
measure: body weight reduction in %
timeFrame: after 6 and 12 months
measure: cardiovascular risk
timeFrame: after 3,6 and 12 months
measure: Quality of life
timeFrame: after 3,6 and 12 months
measure: Nutrition and physical activity
timeFrame: after 3,6 and 12 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: KiloCoach e.U.
city: Berlin
country: Germany
facility: Charité- Universitätsmedizin Berlin
city: Regensburg
country: Germany
facility: University Hospital Regensburg
Study officials:
affiliation: Charite University, Berlin, Germany
name: Luzia Valentini, Doctor
role: PRINCIPAL_INVESTIGATOR
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