NCT00435734

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Jul 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jul 1999Dec 2030

Study Start

First participant enrolled

July 1, 1999

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2007

Completed
23.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

31.4 years

First QC Date

February 14, 2007

Last Update Submit

November 3, 2020

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • change of BMI-SDS

    20 years

Secondary Outcomes (5)

  • change of GI hormones

    10 years

  • change of adipocytokines

    10 years

  • change of cardiovascualr risk factors

    10 years

  • change of metabolomics

    10 years

  • change of psychological variables

    10 years

Interventions

obesity interventionBEHAVIORAL

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

clinic based study of obese children

You may qualify if:

  • BMI\> 97. percentile for age and gender

You may not qualify if:

  • Psychiatric disorders
  • Endocrine disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestische Children´s Hospital

Datteln, 45711, Germany

Location

Related Publications (43)

  • 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.

    PMID: 31996898DERIVED

  • 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.

    PMID: 31840425DERIVED

  • 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.

    PMID: 28238482DERIVED

  • 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.

    PMID: 27285295DERIVED

  • 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.

    PMID: 26881241DERIVED

  • 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.

    PMID: 25781361DERIVED

  • 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.

    PMID: 25243573DERIVED

  • 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.

    PMID: 24819256DERIVED

  • 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.

    PMID: 24670085DERIVED

  • 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.

    PMID: 24283216DERIVED

  • 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.

    PMID: 24075648DERIVED

  • 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.

    PMID: 23703723DERIVED

  • 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.

    PMID: 23519644DERIVED

  • 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.

    PMID: 23485031DERIVED

  • 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.

    PMID: 23211576DERIVED

  • 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.

    PMID: 22438225DERIVED

  • 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.

    PMID: 22095114DERIVED

  • 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.

    PMID: 22068813DERIVED

  • 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.

    PMID: 21880803DERIVED

  • 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.

    PMID: 21648278DERIVED

  • 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.

    PMID: 21489579DERIVED

  • 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.

    PMID: 21372613DERIVED

  • 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.

    PMID: 21366812DERIVED

  • 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.

    PMID: 21198359DERIVED

  • 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.

    PMID: 20827664DERIVED

  • 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.

    PMID: 20536946DERIVED

  • 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.

    PMID: 20432813DERIVED

  • 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.

    PMID: 20219965DERIVED

  • 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.

    PMID: 20051022DERIVED

  • 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.

    PMID: 19922035DERIVED

  • 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.

    PMID: 19766264DERIVED

  • 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.

    PMID: 19576664DERIVED

  • 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.

    PMID: 19492578DERIVED

  • 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.

    PMID: 19442975DERIVED

  • 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.

    PMID: 19303970DERIVED

  • 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.

    PMID: 19224892DERIVED

  • 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.

    PMID: 19155319DERIVED

  • 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.

    PMID: 18799002DERIVED

  • 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.

    PMID: 18728159DERIVED

  • 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.

    PMID: 18397979DERIVED

  • 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.

    PMID: 18031749DERIVED

  • 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.

    PMID: 17854392DERIVED

  • 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.

    PMID: 17656603DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

frozen Serum probes

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Reinehr

    Vestische Children´s Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Pediatric Endocrinology Diabetes and Nutrition Medicine

Study Record Dates

First Submitted

February 14, 2007

First Posted

February 15, 2007

Study Start

July 1, 1999

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

DE(1)