Obesity Intervention "Obeldicks" for Obese Children, Adolescents and Their Parents
NCT ID: NCT00435734
Last Updated: 2020-11-05
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Total Enrollment
4000 participants
Study Classification
OBSERVATIONAL
Study Start Date
1999-07-31
Study Completion Date
2030-12-31
Brief Summary
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The intervention program "Obeldicks" was developed for obese children aged 6 to 16 years. This intervention is gender- and age specific. The 12-months intervention is based on nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality of structure, process and results of the intervention. Primary outcome measure is change of weight status as standard deviation score of BMI. Furthermore, cardiovascular risk factor profile, hormones (e.g. iGF-I, thyroid hormones, vitamin D status)adipocytokines, GI- hormones, intima media thickness are measured prior to and after the one-year intervention. The changes of these hormones and adipocytokines will allow to answer the questions whether the alterations of these hormones are a cause or consequence of overweight. Additionally, a genetic screening is performed to characterize the participants to probably predict response to intervention.
Detailed Description
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Conditions
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Obesity
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Interventions
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obesity intervention
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* BMI\> 97. percentile for age and gender
Exclusion Criteria
* Psychiatric disorders
* Endocrine disorders
* Endocrine disorders
Minimum Eligible Age
6 Years
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Witten/Herdecke
OTHER
Sponsor Role
lead
Responsible Party
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Thomas Reinehr
Head of Department of Pediatric Endocrinology Diabetes and Nutrition Medicine
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Thomas Reinehr
Role: PRINCIPAL_INVESTIGATOR
Vestische Children´s Hospital
Locations
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Vestische Children´s Hospital
Datteln, , Germany
Site Status
Countries
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Germany
References
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Reinehr T, Kulle A, Barth A, Ackermann J, Lass N, Holterhus PM. Sex Hormone Profile in Pubertal Boys With Gynecomastia and Pseudogynecomastia. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgaa044. doi: 10.1210/clinem/dgaa044.
Reference Type
DERIVED
Rothermel J, Lass N, Barth A, Reinehr T. Link between omentin-1, obesity and insulin resistance in children: Findings from a longitudinal intervention study. Pediatr Obes. 2020 May;15(5):e12605. doi: 10.1111/ijpo.12605. Epub 2019 Dec 16.
Reference Type
DERIVED
Reinehr T, Bosse C, Lass N, Rothermel J, Knop C, Roth CL. Effect of Weight Loss on Puberty Onset in Overweight Children. J Pediatr. 2017 May;184:143-150.e1. doi: 10.1016/j.jpeds.2017.01.066. Epub 2017 Feb 24.
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DERIVED
Reinehr T, Lass N, Toschke C, Rothermel J, Lanzinger S, Holl RW. Which Amount of BMI-SDS Reduction Is Necessary to Improve Cardiovascular Risk Factors in Overweight Children? J Clin Endocrinol Metab. 2016 Aug;101(8):3171-9. doi: 10.1210/jc.2016-1885. Epub 2016 Jun 10.
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DERIVED
Hellmuth C, Kirchberg FF, Lass N, Harder U, Peissner W, Koletzko B, Reinehr T. Tyrosine Is Associated with Insulin Resistance in Longitudinal Metabolomic Profiling of Obese Children. J Diabetes Res. 2016;2016:2108909. doi: 10.1155/2016/2108909. Epub 2015 Dec 21.
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DERIVED
Reinehr T, Elfers C, Lass N, Roth CL. Irisin and its relation to insulin resistance and puberty in obese children: a longitudinal analysis. J Clin Endocrinol Metab. 2015 May;100(5):2123-30. doi: 10.1210/jc.2015-1208. Epub 2015 Mar 17.
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DERIVED
Reinehr T, Wolters B, Knop C, Lass N, Holl RW. Strong effect of pubertal status on metabolic health in obese children: a longitudinal study. J Clin Endocrinol Metab. 2015 Jan;100(1):301-8. doi: 10.1210/jc.2014-2674.
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DERIVED
Reinehr T, Wolters B, Roth CL, Hinney A. FTO gene: association to weight regain after lifestyle intervention in overweight children. Horm Res Paediatr. 2014;81(6):391-6. doi: 10.1159/000358328. Epub 2014 May 7.
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DERIVED
Reinehr T, Kulle A, Wolters B, Knop C, Lass N, Welzel M, Holterhus PM. Relationships between 24-hour urinary free cortisol concentrations and metabolic syndrome in obese children. J Clin Endocrinol Metab. 2014 Jul;99(7):2391-9. doi: 10.1210/jc.2013-4398. Epub 2014 Mar 26.
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DERIVED
Roth CL, Hinney A, Schur EA, Elfers CT, Reinehr T. Association analyses for dopamine receptor gene polymorphisms and weight status in a longitudinal analysis in obese children before and after lifestyle intervention. BMC Pediatr. 2013 Nov 27;13:197. doi: 10.1186/1471-2431-13-197.
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DERIVED
Uysal Y, Wolters B, Knop C, Reinehr T. Components of the metabolic syndrome are negative predictors of weight loss in obese children with lifestyle intervention. Clin Nutr. 2014 Aug;33(4):620-5. doi: 10.1016/j.clnu.2013.09.007. Epub 2013 Sep 18.
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DERIVED
Reinehr T, Kulle A, Wolters B, Lass N, Welzel M, Riepe F, Holterhus PM. Steroid hormone profiles in prepubertal obese children before and after weight loss. J Clin Endocrinol Metab. 2013 Jun;98(6):E1022-30. doi: 10.1210/jc.2013-1173. Epub 2013 May 23.
Reference Type
DERIVED
Volckmar AL, Putter C, Song JY, Graniger J, Knoll N, Wolters B, Hebebrand J, Scherag A, Reinehr T, Hinney A. Analyses of non-synonymous obesity risk alleles in SH2B1 (rs7498665) and APOB48R (rs180743) in obese children and adolescents undergoing a 1-year lifestyle intervention. Exp Clin Endocrinol Diabetes. 2013 Jun;121(6):334-7. doi: 10.1055/s-0033-1334875. Epub 2013 Mar 21.
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DERIVED
Reinehr T, Wunsch R, Putter C, Scherag A. Relationship between carotid intima-media thickness and metabolic syndrome in adolescents. J Pediatr. 2013 Aug;163(2):327-32. doi: 10.1016/j.jpeds.2013.01.032. Epub 2013 Feb 26.
Reference Type
DERIVED
Wolters B, Lass N, Reinehr T. TSH and free triiodothyronine concentrations are associated with weight loss in a lifestyle intervention and weight regain afterwards in obese children. Eur J Endocrinol. 2013 Feb 15;168(3):323-9. doi: 10.1530/EJE-12-0981. Print 2013 Mar.
Reference Type
DERIVED
Reinehr T, Woelfle J, Wunsch R, Roth CL. Fibroblast growth factor 21 (FGF-21) and its relation to obesity, metabolic syndrome, and nonalcoholic fatty liver in children: a longitudinal analysis. J Clin Endocrinol Metab. 2012 Jun;97(6):2143-50. doi: 10.1210/jc.2012-1221. Epub 2012 Mar 21.
Reference Type
DERIVED
Scherag A, Kleber M, Boes T, Kolbe AL, Ruth A, Grallert H, Illig T, Heid IM, Toschke AM, Grau K; NUGENOB Consortium; Sorensen TI, Hebebrand J, Hinney A, Reinehr T. SDCCAG8 obesity alleles and reduced weight loss after a lifestyle intervention in overweight children and adolescents. Obesity (Silver Spring). 2012 Feb;20(2):466-70. doi: 10.1038/oby.2011.339. Epub 2011 Nov 17.
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DERIVED
Knoll N, Volckmar AL, Putter C, Scherag A, Kleber M, Hebebrand J, Hinney A, Reinehr T. The fatty acid amide hydrolase (FAAH) gene variant rs324420 AA/AC is not associated with weight loss in a 1-year lifestyle intervention for obese children and adolescents. Horm Metab Res. 2012 Jan;44(1):75-7. doi: 10.1055/s-0031-1291306. Epub 2011 Nov 8.
Reference Type
DERIVED
Lass N, Kleber M, Winkel K, Wunsch R, Reinehr T. Effect of lifestyle intervention on features of polycystic ovarian syndrome, metabolic syndrome, and intima-media thickness in obese adolescent girls. J Clin Endocrinol Metab. 2011 Nov;96(11):3533-40. doi: 10.1210/jc.2011-1609. Epub 2011 Aug 31.
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DERIVED
Kleber M, Schwarz A, Reinehr T. Obesity in children and adolescents: relationship to growth, pubarche, menarche, and voice break. J Pediatr Endocrinol Metab. 2011;24(3-4):125-30. doi: 10.1515/jpem.2011.089.
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DERIVED
Reinehr T, Woelfle J, Roth CL. Lack of association between apelin, insulin resistance, cardiovascular risk factors, and obesity in children: a longitudinal analysis. Metabolism. 2011 Sep;60(9):1349-54. doi: 10.1016/j.metabol.2011.02.005. Epub 2011 Apr 12.
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DERIVED
Vogel CI, Boes T, Reinehr T, Roth CL, Scherag S, Scherag A, Hebebrand J, Hinney A. Common variants near MC4R: exploring gender effects in overweight and obese children and adolescents participating in a lifestyle intervention. Obes Facts. 2011;4(1):67-75. doi: 10.1159/000324557. Epub 2011 Feb 22.
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DERIVED
Reinehr T, Scherag A, Wang HJ, Roth CL, Kleber M, Scherag S, Boes T, Vogel C, Hebebrand J, Hinney A. Relationship between MTNR1B (melatonin receptor 1B gene) polymorphism rs10830963 and glucose levels in overweight children and adolescents. Pediatr Diabetes. 2011 Jun;12(4 Pt 2):435-41. doi: 10.1111/j.1399-5448.2010.00738.x. Epub 2011 Mar 3.
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DERIVED
Reinehr T, Kleber M, Toschke AM, Woelfle J, Roth CL. Longitudinal association between IGFBP-1 levels and parameters of the metabolic syndrome in obese children before and after weight loss. Int J Pediatr Obes. 2011 Aug;6(3-4):236-43. doi: 10.3109/17477166.2010.544739. Epub 2011 Jan 3.
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DERIVED
Kleber M, deSousa G, Papcke S, Wabitsch M, Reinehr T. Impaired glucose tolerance in obese white children and adolescents: three to five year follow-up in untreated patients. Exp Clin Endocrinol Diabetes. 2011 Mar;119(3):172-6. doi: 10.1055/s-0030-1263150. Epub 2010 Sep 8.
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DERIVED
Kleber M, Lass N, Papcke S, Wabitsch M, Reinehr T. One-year follow-up of untreated obese white children and adolescents with impaired glucose tolerance: high conversion rate to normal glucose tolerance. Diabet Med. 2010 May;27(5):516-21. doi: 10.1111/j.1464-5491.2010.02991.x.
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DERIVED
Reinehr T, Roth CL, Enriori PJ, Masur K. Changes of dipeptidyl peptidase IV (DPP-IV) in obese children with weight loss: relationships to peptide YY, pancreatic peptide, and insulin sensitivity. J Pediatr Endocrinol Metab. 2010 Jan-Feb;23(1-2):101-8. doi: 10.1515/jpem.2010.23.1-2.101.
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DERIVED
Reinehr T, Kleber M, Lass N, Toschke AM. Body mass index patterns over 5 y in obese children motivated to participate in a 1-y lifestyle intervention: age as a predictor of long-term success. Am J Clin Nutr. 2010 May;91(5):1165-71. doi: 10.3945/ajcn.2009.28705. Epub 2010 Mar 10.
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DERIVED
Reinehr T, Kleber M, Toschke AM. Former small for gestational age (SGA) status is associated to changes of insulin resistance in obese children during weight loss. Pediatr Diabetes. 2010 Sep;11(6):431-7. doi: 10.1111/j.1399-5448.2009.00624.x. Epub 2009 Dec 30.
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Reinehr T, Kleber M, de Sousa G, Andler W. Leptin concentrations are a predictor of overweight reduction in a lifestyle intervention. Int J Pediatr Obes. 2009;4(4):215-23. doi: 10.3109/17477160902952464.
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Roth CL, Enriori PJ, Gebhardt U, Hinney A, Muller HL, Hebebrand J, Reinehr T, Cowley MA. Changes of peripheral alpha-melanocyte-stimulating hormone in childhood obesity. Metabolism. 2010 Feb;59(2):186-94. doi: 10.1016/j.metabol.2009.06.031. Epub 2009 Sep 18.
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DERIVED
Reinehr T, Wunsch R. Relationships between cardiovascular risk profile, ultrasonographic measurement of intra-abdominal adipose tissue, and waist circumference in obese children. Clin Nutr. 2010 Feb;29(1):24-30. doi: 10.1016/j.clnu.2009.06.004. Epub 2009 Jul 2.
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Reinehr T, Panteliadou A, de Sousa G, Andler W. Insulin-like growth factor-I, insulin-like growth factor binding protein-3 and growth in obese children before and after reduction of overweight. J Pediatr Endocrinol Metab. 2009 Mar;22(3):225-33. doi: 10.1515/jpem.2009.22.3.225.
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Reinehr T, Kleber M, Toschke AM. Lifestyle intervention in obese children is associated with a decrease of the metabolic syndrome prevalence. Atherosclerosis. 2009 Nov;207(1):174-80. doi: 10.1016/j.atherosclerosis.2009.03.041. Epub 2009 Apr 5.
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Reinehr T, Schmidt C, de Sousa G, Andler W. Association between leptin and transaminases: 1-year follow-up study in 180 overweight children. Metabolism. 2009 Apr;58(4):497-503. doi: 10.1016/j.metabol.2008.11.007.
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Reinehr T, Schmidt C, Toschke AM, Andler W. Lifestyle intervention in obese children with non-alcoholic fatty liver disease: 2-year follow-up study. Arch Dis Child. 2009 Jun;94(6):437-42. doi: 10.1136/adc.2008.143594. Epub 2009 Feb 17.
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Reinehr T, Kleber M, Toschke AM. Small for gestational age status is associated with metabolic syndrome in overweight children. Eur J Endocrinol. 2009 Apr;160(4):579-84. doi: 10.1530/EJE-08-0914. Epub 2009 Jan 20.
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Muller TD, Hinney A, Scherag A, Nguyen TT, Schreiner F, Schafer H, Hebebrand J, Roth CL, Reinehr T. 'Fat mass and obesity associated' gene (FTO): no significant association of variant rs9939609 with weight loss in a lifestyle intervention and lipid metabolism markers in German obese children and adolescents. BMC Med Genet. 2008 Sep 17;9:85. doi: 10.1186/1471-2350-9-85.
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Reinehr T, Roth CL. Fetuin-A and its relation to metabolic syndrome and fatty liver disease in obese children before and after weight loss. J Clin Endocrinol Metab. 2008 Nov;93(11):4479-85. doi: 10.1210/jc.2008-1505. Epub 2008 Aug 26.
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Reinehr T, Stoffel-Wagner B, Roth CL. Retinol-binding protein 4 and its relation to insulin resistance in obese children before and after weight loss. J Clin Endocrinol Metab. 2008 Jun;93(6):2287-93. doi: 10.1210/jc.2007-2745. Epub 2008 Apr 8.
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Reinehr T, Wunsch R, de Sousa G, Toschke AM. Relationship between metabolic syndrome definitions for children and adolescents and intima-media thickness. Atherosclerosis. 2008 Jul;199(1):193-200. doi: 10.1016/j.atherosclerosis.2007.09.041. Epub 2007 Nov 26.
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Reinehr T, de Sousa G, Roth CL. Obestatin and ghrelin levels in obese children and adolescents before and after reduction of overweight. Clin Endocrinol (Oxf). 2008 Feb;68(2):304-10. doi: 10.1111/j.1365-2265.2007.03042.x. Epub 2007 Sep 14.
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Reinehr T, de Sousa G, Alexy U, Kersting M, Andler W. Vitamin D status and parathyroid hormone in obese children before and after weight loss. Eur J Endocrinol. 2007 Aug;157(2):225-32. doi: 10.1530/EJE-07-0188.
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Other Identifiers
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GFEL011174506
Identifier Type: -
Identifier Source: org_study_id