Efficacy of a Web-based Weight Loss Program

Charite University, Berlin, Germany84 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Overweight Obese

Interventions

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.

ControlOTHER

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

KiloCoach e.U.

Vienna, Austria

Charité- Universitätsmedizin Berlin

Berlin, Germany

University Hospital Regensburg

Regensburg, Germany

Outcomes

Primary Outcomes

body weight reduction in %

Time frame: after 3 months

Secondary Outcomes

body weight reduction in %

Time frame: 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.)

Time frame: 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".

Time frame: 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.

Time frame: after 3,6 and 12 months