Efficacy of a Web-based Weight Loss Program

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01634204
• Other study ID #: KiloCoach
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 3, 2012
• Last updated: July 5, 2012
• Start date: September 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2012
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Berliner Datenschutzgesetz (BlnDSG)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: July 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obese
• Overweight
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
Austria	KiloCoach e.U.	Vienna
Germany	Charité- Universitätsmedizin Berlin	Berlin
Germany	University Hospital Regensburg	Regensburg

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	KiloCoach e.U., University Hospital Regensburg

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (10)

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. — View Citation

Goldstein DJ. Beneficial health effects of modest weight loss. Int J Obes Relat Metab Disord. 1992 Jun;16(6):397-415. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2006 May 23. Erratum in: BMJ. 2006 Jun 17;332(7555):1418. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight reduction in %		after 3 months	No
Secondary	body weight reduction in %		after 6 and 12 months	No
Secondary	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.)	after 3,6 and 12 months	No
Secondary	Quality of life	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	No
Secondary	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.	after 3,6 and 12 months	No