Obese, Overweight
Conditions
Keywords
weight reduction, web-based intervention, cost-effective, overweight, obesity, cardiovascular risk
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.
Interventions
OTHERKiloCoach
Study participants in this arm will use the program to record nutrition and physical activity on at least 4 days per week within the first and ad libitum within the second 3 months of the intervention period. Study visits will be conducted at baseline as well as after 1, 3 and 6 months. After 12 months a follow up visit will be conducted.
OTHERControl
Study subjects try to reduce their body weight on their own. They are free to exercise and/or change nutritional habits. Not allowed is taking part in any structured weight loss program. Study visits will be conducted at baseline as well as after 1,3 and 6 months. A follow up visit will be conducted after 12 months.
Sponsors
KiloCoach e.U.
University Hospital Regensburg
Charite University, Berlin, Germany
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| body weight reduction in % | after 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body weight reduction in % | after 6 and 12 months | — |
| cardiovascular risk | after 3,6 and 12 months | Cardiovascular risk is assessed by hsCRP, Fetuin A, LDL/HDL-ratio, waist-to-hip-ratio, HOMA-IR, blood pressure, body mass index, lean body mass (LBM), fat mass (FM), body cell mass (BCM.) |
| Quality of life | after 3,6 and 12 months | Quality of life is assessed by Obesity and Weight-Loss Quality of Life-Instrument and Weight related symptom measure. |
| Nutrition and physical activity | after 3,6 and 12 months | Nutritional intake (controls) is assessed by 3-day dietary protocols. Physical activity is assessed by International physical activity questionnaire (IPAQ-long), lower limb strength and phase angle. |
Countries
Austria, Germany
Outcome results
None listed