Efficacy of a Web-based Weight Loss Program

July 5, 2012 updated by: Luzia Valentini, Charite University, Berlin, Germany

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • KiloCoach e.U.
  • Germany
      • Berlin, Germany, 10117
        • Charité- Universitätsmedizin Berlin
      • Regensburg, Germany
        • University Hospital Regensburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
body weight reduction in %
Time Frame: after 3 months
after 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body weight reduction in %
Time Frame: after 6 and 12 months
after 6 and 12 months
cardiovascular risk
Time Frame: 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.)
after 3,6 and 12 months
Quality of life
Time Frame: 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".
after 3,6 and 12 months
Nutrition and physical activity
Time Frame: 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.
after 3,6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

University Hospital Regensburg
KiloCoach e.U.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

July 3, 2012

First Submitted That Met QC Criteria

July 5, 2012

First Posted (Estimate)

July 6, 2012

Study Record Updates

Last Update Posted (Estimate)

July 6, 2012

Last Update Submitted That Met QC Criteria

July 5, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KiloCoach

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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