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CompletedNCT01067157LOGICUpdated Nov 30, 2023

Long-term Effects of Lifestyle Intervention in Obesity and Genetic Influence

An interventional study of LOGIC in Obesity and Cardiovascular Risk, sponsored by Technical University of Munich. Completed at 1 site in Germany. Open to participants aged 6 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-30.

Sponsored by Technical University of Munich · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 1 month after the study started (first participant enrolled Jan 2006, registered Feb 2010).
Phase
Not applicable
Study type
Interventional
Enrollment
1,500
Allocation
Not applicable
Ages
6 Years to 19 Years
Sex
All
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Study summary

The purpose of the study is to determine the genetic influence on short-, middle- and longterm effects of an inpatient lifestyle therapy program in overweight and obese children and adolescents.

Read the detailed description

In Germany, as in other countries, overweight and obesity affects a growing number of children and adolescents. Obesity-related diseases such as arterial hypertension, disorders of glucose and lipid metabolism and an increase in inflammation markers are associated with higher morbidity and mortality in early life, therefore effective therapy concepts are needed.

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).

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Conditions studied

  • Obesity
  • Cardiovascular Risk

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Keywords

  • Obesity
  • overweight
  • childhood
  • adolescence
  • inpatient therapy
  • lifestyle intervention
  • cardiovascular risk
  • gene-lifestyle-interaction
  • Obesity and associated cardiovascular risk in childhood and adolescence,
  • health behaviour
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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 1,500 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Overweight or obese children (BMI >90th percentile for age and gender), who obtained an inpatient lifestyle intervention in the participating clinic.
  • Children with written consent from their parents and the acceptance of a 10-year follow-up.

Exclusion criteria

Exclusion Criteria:

  • Children without written consent from their parents.
  • Children with monogenetic diseases with influence on obesity (e.g. Prader-Willi-Syndrome) or with secondary obesity.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,500 participants (actual)

Study arms

  • Other
    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.

    Behavioral: LOGIC

Interventions

  • BehavioralLOGIC

    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)

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What researchers measure

Primary outcomes

  1. Influence of gene variants in FTO, MC4R and TMEM-18 on reduction of overweight and obesity measured by standard deviation score Body Mass Index (sds-BMI)

    Time frame: 16 years

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Study locations

1 site
  • Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich, Germany
    Munich, Bavaria 80992, Germany
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References and documents

Publications

  • 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. PubMed 16960161 ↗
  • 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. PubMed 18057335 ↗
  • 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. PubMed 18057339 ↗
  • 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. PubMed 19506565 ↗
  • 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. PubMed 19363514 ↗
  • 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. PubMed 15837955 ↗
  • 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. PubMed 19505623 ↗
  • 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. PubMed 34666255 ↗
  • 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. PubMed 23434121 ↗
  • 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. PubMed 22429873 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01067157
Lead sponsor
Technical University of Munich
Collaborators
Rehabilitation clinic Schönsicht, 83471 Berchtesgaden
Responsible party
Sponsor
First posted
Feb 11, 2010
Start date
Jan 1, 2006
Primary completion
Dec 31, 2013
Completion
Dec 31, 2020
Last update
Nov 30, 2023

Study contacts

Martin Halle, Prof. M.D.
study chair · Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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