Long-term Effects of Lifestyle Intervention in Obesity and Genetic Influence
NCT ID: NCT01067157
Last Updated: 2023-11-30
Study Results
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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COMPLETED
NA
1500 participants
INTERVENTIONAL
2006-01-01
2020-12-31
Brief Summary
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Detailed Description
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The aim of this study is to evaluate the effects of a 4-6 week inpatient obesity lifestyle therapy program over 10 years and the genetic influence on the short-, middle- and longterm outcome.
The lifestyle intervention consists of physical exercise, nutrition education and behaviour therapy based on the criterions developed by the German Obesity Group (degree of weight reduction, improvement of comorbidity and health behaviour, minimising of side effects).
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
Other = Lifestyle intervention
A: Medical examination before and after inpatient therapy (clinic staff), questionnaires.
Further medical examination and questionnaires after 6 months, 1, 2, 5 and 10 years at home by pediatrics or general practitioner.
The lifestyle intervention includes an age-specific diet (1200-1800 kcal/d), 11 h/wk physical activity (walking, swimming, sports) and behavioural therapy.
LOGIC
Experimental group:
Diet (1200-1800 kcal/d), Exercise: 11 h/wk physical activity, Behavioural therapy (group training, 1-3h/wk individualized personal instructions, 2 h parents work)
Interventions
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LOGIC
Experimental group:
Diet (1200-1800 kcal/d), Exercise: 11 h/wk physical activity, Behavioural therapy (group training, 1-3h/wk individualized personal instructions, 2 h parents work)
Eligibility Criteria
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Inclusion Criteria
* Children with written consent from their parents and the acceptance of a 10-year follow-up.
Exclusion Criteria
* Children with monogenetic diseases with influence on obesity (e.g. Prader-Willi-Syndrome) or with secondary obesity.
6 Years
19 Years
ALL
Yes
Sponsors
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Rehabilitation clinic Schönsicht, 83471 Berchtesgaden
UNKNOWN
Technical University of Munich
OTHER
Responsible Party
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Principal Investigators
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Martin Halle, Prof. M.D.
Role: STUDY_CHAIR
Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich, Germany
Locations
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Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich, Germany
Munich, Bavaria, Germany
Countries
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References
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Reinehr T, de Sousa G, Toschke AM, Andler W. Long-term follow-up of cardiovascular disease risk factors in children after an obesity intervention. Am J Clin Nutr. 2006 Sep;84(3):490-6. doi: 10.1093/ajcn/84.3.490.
Baker JL, Olsen LW, Sorensen TI. Childhood body-mass index and the risk of coronary heart disease in adulthood. N Engl J Med. 2007 Dec 6;357(23):2329-37. doi: 10.1056/NEJMoa072515.
Bibbins-Domingo K, Coxson P, Pletcher MJ, Lightwood J, Goldman L. Adolescent overweight and future adult coronary heart disease. N Engl J Med. 2007 Dec 6;357(23):2371-9. doi: 10.1056/NEJMsa073166.
Owen CG, Whincup PH, Orfei L, Chou QA, Rudnicka AR, Wathern AK, Kaye SJ, Eriksson JG, Osmond C, Cook DG. Is body mass index before middle age related to coronary heart disease risk in later life? Evidence from observational studies. Int J Obes (Lond). 2009 Aug;33(8):866-77. doi: 10.1038/ijo.2009.102. Epub 2009 Jun 9.
Birch LL, Ventura AK. Preventing childhood obesity: what works? Int J Obes (Lond). 2009 Apr;33 Suppl 1:S74-81. doi: 10.1038/ijo.2009.22.
Daniels SR, Arnett DK, Eckel RH, Gidding SS, Hayman LL, Kumanyika S, Robinson TN, Scott BJ, St Jeor S, Williams CL. Overweight in children and adolescents: pathophysiology, consequences, prevention, and treatment. Circulation. 2005 Apr 19;111(15):1999-2012. doi: 10.1161/01.CIR.0000161369.71722.10.
McCall A, Raj R. Exercise for prevention of obesity and diabetes in children and adolescents. Clin Sports Med. 2009 Jul;28(3):393-421. doi: 10.1016/j.csm.2009.03.001.
Siegrist M, Heitkamp M, Braun I, Vogg N, Haller B, Langhof H, Koenig W, Halle M. Changes of omentin-1 and chemerin during 4 weeks of lifestyle intervention and 1 year follow-up in children with obesity. Clin Nutr. 2021 Nov;40(11):5648-5654. doi: 10.1016/j.clnu.2021.09.042. Epub 2021 Oct 8.
Rank M, Siegrist M, Wilks DC, Langhof H, Wolfarth B, Haller B, Koenig W, Halle M. The cardio-metabolic risk of moderate and severe obesity in children and adolescents. J Pediatr. 2013 Jul;163(1):137-42. doi: 10.1016/j.jpeds.2013.01.020. Epub 2013 Feb 20.
Rank M, Siegrist M, Wilks DC, Haller B, Wolfarth B, Langhof H, Halle M. Long-term effects of an inpatient weight-loss program in obese children and the role of genetic predisposition-rationale and design of the LOGIC-trial. BMC Pediatr. 2012 Mar 19;12:30. doi: 10.1186/1471-2431-12-30.
Related Links
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Related Info
Related Info
Other Identifiers
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LOGIC
Identifier Type: -
Identifier Source: org_study_id