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Efficacy of a Web-based Weight Loss Program

Primary Purpose

Overweight, Obese

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
KiloCoach
Control
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring weight reduction, web-based intervention, cost-effective, overweight, obesity, cardiovascular risk

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • KiloCoach e.U.
  • Charité- Universitätsmedizin Berlin
  • University Hospital Regensburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

KiloCoach

Control

Arm Description

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.

Study subjects try to reduce body weight on their own, without participating in an organized weight loss program, over a period of 6 months.

Outcomes

Primary Outcome Measures

body weight reduction in %

Secondary Outcome Measures

body weight reduction in %
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.)
Quality of life
Quality of life is assessed by "Obesity and Weight-Loss Quality of Life-Instrument" and "Weight related symptom measure".
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.

Full Information

First Posted
July 3, 2012
Last Updated
July 5, 2012
Sponsor
Charite University, Berlin, Germany
Collaborators
KiloCoach e.U., University Hospital Regensburg
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1. Study Identification

Unique Protocol Identification Number
NCT01634204
Brief Title
Efficacy of a Web-based Weight Loss Program
Official Title
Is the Support of a Web-based Weight Loss Program Effective in Supporting Self-initiated Weight Loss and Lifestyle Changes?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
KiloCoach e.U., University Hospital Regensburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese
Keywords
weight reduction, web-based intervention, cost-effective, overweight, obesity, cardiovascular risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KiloCoach
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Study subjects try to reduce body weight on their own, without participating in an organized weight loss program, over a period of 6 months.
Intervention Type
Other
Intervention Name(s)
KiloCoach
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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 Outcome Measure Information:
Title
body weight reduction in %
Time Frame
after 3 months
Secondary Outcome Measure Information:
Title
body weight reduction in %
Time Frame
after 6 and 12 months
Title
cardiovascular risk
Description
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
Title
Quality of life
Description
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
Title
Nutrition and physical activity
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luzia Valentini, Doctor
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
KiloCoach e.U.
City
Vienna
Country
Austria
Facility Name
Charité- Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
University Hospital Regensburg
City
Regensburg
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
16720619
Citation
Truby H, Baic S, deLooy A, Fox KR, Livingstone MB, Logan CM, Macdonald IA, Morgan LM, Taylor MA, Millward DJ. Randomised controlled trial of four commercial weight loss programmes in the UK: initial findings from the BBC "diet trials". BMJ. 2006 Jun 3;332(7553):1309-14. doi: 10.1136/bmj.38833.411204.80. Epub 2006 May 23. Erratum In: BMJ. 2006 Jun 17;332(7555):1418.
Results Reference
background
PubMed Identifier
16908795
Citation
Tate DF, Jackvony EH, Wing RR. A randomized trial comparing human e-mail counseling, computer-automated tailored counseling, and no counseling in an Internet weight loss program. Arch Intern Med. 2006 Aug 14-28;166(15):1620-5. doi: 10.1001/archinte.166.15.1620.
Results Reference
background
PubMed Identifier
12187404
Citation
Harvey-Berino J, Pintauro S, Buzzell P, DiGiulio M, Casey Gold B, Moldovan C, Ramirez E. Does using the Internet facilitate the maintenance of weight loss? Int J Obes Relat Metab Disord. 2002 Sep;26(9):1254-60. doi: 10.1038/sj.ijo.0802051.
Results Reference
background
PubMed Identifier
20478333
Citation
Harvey-Berino J, West D, Krukowski R, Prewitt E, VanBiervliet A, Ashikaga T, Skelly J. Internet delivered behavioral obesity treatment. Prev Med. 2010 Aug;51(2):123-8. doi: 10.1016/j.ypmed.2010.04.018. Epub 2010 May 15.
Results Reference
background
PubMed Identifier
11231746
Citation
Tate DF, Wing RR, Winett RA. Using Internet technology to deliver a behavioral weight loss program. JAMA. 2001 Mar 7;285(9):1172-7. doi: 10.1001/jama.285.9.1172.
Results Reference
background
PubMed Identifier
18954247
Citation
Krukowski RA, Harvey-Berino J, Ashikaga T, Thomas CS, Micco N. Internet-based weight control: the relationship between web features and weight loss. Telemed J E Health. 2008 Oct;14(8):775-82. doi: 10.1089/tmj.2007.0132.
Results Reference
background
PubMed Identifier
9578299
Citation
Galanis DJ, Kolonel LN, Lee J, Le Marchand L. Anthropometric predictors of breast cancer incidence and survival in a multi-ethnic cohort of female residents of Hawaii, United States. Cancer Causes Control. 1998 Mar;9(2):217-24. doi: 10.1023/a:1008842613331.
Results Reference
background
PubMed Identifier
10880035
Citation
Trentham-Dietz A, Newcomb PA, Egan KM, Titus-Ernstoff L, Baron JA, Storer BE, Stampfer M, Willett WC. Weight change and risk of postmenopausal breast cancer (United States). Cancer Causes Control. 2000 Jul;11(6):533-42. doi: 10.1023/a:1008961931534.
Results Reference
background
PubMed Identifier
1322866
Citation
Goldstein DJ. Beneficial health effects of modest weight loss. Int J Obes Relat Metab Disord. 1992 Jun;16(6):397-415.
Results Reference
background
PubMed Identifier
22722385
Citation
Longin R, Grasse M, Aspalter R, Waldherr K. Effectiveness of the online weight reduction program KiloCoach and comparison with other evaluated commercial direct intervention and online programs. Obes Facts. 2012;5(3):372-83. doi: 10.1159/000339726. Epub 2012 Jun 14.
Results Reference
background

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Efficacy of a Web-based Weight Loss Program

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