Overview

This trial is active, not recruiting.

Conditions overweight, obese
Treatments kilocoach, control
Phase phase 2
Sponsor Charite University, Berlin, Germany
Collaborator KiloCoach e.U.
Start date September 2011
End date October 2012
Trial size 84 participants
Trial identifier NCT01634204, KiloCoach

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
kilocoach
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.
(No Intervention)
Study subjects try to reduce body weight on their own, without participating in an organized weight loss program, over a period of 6 months.
control
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.

Primary Outcomes

Measure
body weight reduction in %
time frame: after 3 months

Secondary Outcomes

Measure
body weight reduction in %
time frame: after 6 and 12 months
cardiovascular risk
time frame: after 3,6 and 12 months
Quality of life
time frame: after 3,6 and 12 months
Nutrition and physical activity
time frame: after 3,6 and 12 months

Eligibility Criteria

Male or female participants from 30 years up to 65 years old.

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

Additional Information

Official title Is the Support of a Web-based Weight Loss Program Effective in Supporting Self-initiated Weight Loss and Lifestyle Changes?
Principal investigator Luzia Valentini, Doctor
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.