- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01634204
Efficacy of a Web-based Weight Loss Program
Is the Support of a Web-based Weight Loss Program Effective in Supporting Self-initiated Weight Loss and Lifestyle Changes?
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Berlin, Allemagne, 10117
- Charité- Universitätsmedizin Berlin
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Regensburg, Allemagne
- University Hospital Regensburg
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Vienna, L'Autriche
- KiloCoach e.U.
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
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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. |
Aucune 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.
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
body weight reduction in %
Délai: after 3 months
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after 3 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
body weight reduction in %
Délai: after 6 and 12 months
|
after 6 and 12 months
|
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cardiovascular risk
Délai: after 3,6 and 12 months
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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.)
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after 3,6 and 12 months
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Quality of life
Délai: after 3,6 and 12 months
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Quality of life is assessed by "Obesity and Weight-Loss Quality of Life-Instrument" and "Weight related symptom measure".
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after 3,6 and 12 months
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Nutrition and physical activity
Délai: after 3,6 and 12 months
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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.
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after 3,6 and 12 months
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Goldstein DJ. Beneficial health effects of modest weight loss. Int J Obes Relat Metab Disord. 1992 Jun;16(6):397-415.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KiloCoach
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