NCT01067157

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2006

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2013

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

8 years

First QC Date

February 10, 2010

Last Update Submit

November 29, 2023

Conditions

ObesityCardiovascular Risk

Keywords

Obesityoverweightchildhoodadolescenceinpatient therapylifestyle interventioncardiovascular riskgene-lifestyle-interactionObesity and associated cardiovascular risk in childhood and adolescence,health behaviour

Outcome Measures

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)

    16 years

Study Arms (1)

A

OTHER

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

LOGICBEHAVIORAL

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)

A

Eligibility Criteria

Age6 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich, Germany

Munich, Bavaria, 80992, Germany

Location

Related Publications (10)

  • 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.

    PMID: 16960161BACKGROUND

  • 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.

    PMID: 18057335BACKGROUND

  • 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.

    PMID: 18057339BACKGROUND

  • 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.

    PMID: 19506565BACKGROUND

  • 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.

    PMID: 19363514BACKGROUND

  • 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.

    PMID: 15837955BACKGROUND

  • 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.

    PMID: 19505623BACKGROUND

  • 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.

    PMID: 34666255DERIVED

  • 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.

    PMID: 23434121DERIVED

  • 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.

    PMID: 22429873DERIVED

Related Links

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

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

Study Officials

  • Martin Halle, Prof. M.D.

    Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich, Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2010

First Posted

February 11, 2010

Study Start

January 1, 2006

Primary Completion

December 31, 2013

Study Completion

December 31, 2020

Last Updated

November 30, 2023

Record last verified: 2023-11

Locations

DE(1)