Is the Support of a Web-based Weight Loss Program Effective in Supporting Self-initiated Weight Loss and Lifestyle Changes?
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 84
- Locations
- 3
- Primary Endpoint
- body weight reduction in %
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
KiloCoach
Study subjects use the KiloCoach program on at least 4 days per week within the first half of the 6 months intervention period. In the second half, program usage is ad libitum.
Intervention: KiloCoach (Other)
Control
Study subjects try to reduce body weight on their own, without participating in an organized weight loss program, over a period of 6 months.
Intervention: Control (Other)
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)
Investigators
Luzia Valentini
Dr. rer. nat.
Charite University, Berlin, Germany