Efficacy of a Web-based Weight Loss Program

NCT01634204 | Unknown Phase 2

• 1 other identifier: KiloCoach
• Study Type: interventional
• Target: 84
• Locations: 2 countries
• Sites: 3

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.

Conditions

Overweight; Obese

Keywords

weight reduction; web-based intervention; cost-effective; overweight; obesity; cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• body weight reduction in %

  after 3 months

Secondary Outcomes (4)

• body weight reduction in %

  after 6 and 12 months

• cardiovascular risk

  after 3,6 and 12 months

• Quality of life

  after 3,6 and 12 months

• Nutrition and physical activity

  after 3,6 and 12 months

Study Arms (2)

KiloCoach

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.

Other: KiloCoach

Control

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.

Other: Control

Interventions

KiloCoach OTHER

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.

KiloCoach

Control OTHER

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.

Control

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• KiloCoach e.U.: collaborator
• University Hospital Regensburg: collaborator

Study Sites (3)

KiloCoach e.U.

Vienna, Austria

Location

Charité- Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

University Hospital Regensburg

Regensburg, Germany

Location

Related Publications (10)

• 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.

  PMID: 16720619 BACKGROUND

• 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.

  PMID: 16908795 BACKGROUND

• 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.

  PMID: 12187404 BACKGROUND

• 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.

  PMID: 20478333 BACKGROUND

• 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.

  PMID: 11231746 BACKGROUND

• 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.

  PMID: 18954247 BACKGROUND

• 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.

  PMID: 9578299 BACKGROUND

• 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.

  PMID: 10880035 BACKGROUND

• Goldstein DJ. Beneficial health effects of modest weight loss. Int J Obes Relat Metab Disord. 1992 Jun;16(6):397-415.

  PMID: 1322866 BACKGROUND

• 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.

  PMID: 22722385 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Luzia Valentini, Doctor

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. rer. nat.

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 6, 2012
• Study Start: September 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: July 1, 2013
• Last Updated: July 6, 2012

Record last verified: 2012-07

Locations

DE (2); AU (1)