Efficacy of a Web-based Weight Loss Program

Study Overview
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Brief Summary
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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.

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

Conditions
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Overweight, Obese

Intervention / Treatment
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* Other: KiloCoach
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KiloCoach<br>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. | Other: KiloCoach<br>* 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.<br>|
| No Intervention: Control<br>Study subjects try to reduce body weight on their own, without participating in an organized weight loss program, over a period of 6 months. | Other: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight reduction in % |  | after 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight reduction in % |  | after 6 and 12 months | 
| cardiovascular risk | 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.) | after 3,6 and 12 months | 
| Quality of life | Quality of life is assessed by Obesity and Weight-Loss Quality of Life-Instrument and Weight related symptom measure. | after 3,6 and 12 months | 
| Nutrition and physical activity | 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. | after 3,6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight reduction, web-based intervention, cost-effective, overweight, obesity, cardiovascular risk