Efficacy of a Web-based Weight Loss Program

Phase 2

• Conditions: Overweight; Obese
• Interventions: Other: KiloCoach; Other: Control

• Registration Number: NCT01634204
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Status Verified: 2012-07
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-05
• Last Update Submitted: 2012-07-05
• Study First Posted: 2012-07-06
• Last Update Posted: 2012-07-06
• Primary Completion: 2012-10
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KiloCoach	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.
Control	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.

Primary Outcome Measures

Name	Time	Method
body weight reduction in %	after 3 months

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

KiloCoach e.U.; 🇦🇹 Vienna, Austria

Charité- Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

University Hospital Regensburg; 🇩🇪 Regensburg, Germany