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

Primary Purpose

Obesity, Cardiovascular Risk

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
LOGIC
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, overweight, childhood, adolescence, inpatient therapy, lifestyle intervention, cardiovascular risk, gene-lifestyle-interaction, Obesity and associated cardiovascular risk in childhood and adolescence,, health behaviour

Eligibility Criteria

6 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

A

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
February 10, 2010
Last Updated
October 26, 2022
Sponsor
Technical University of Munich
Collaborators
Rehabilitation clinic Schönsicht, 83471 Berchtesgaden
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1. Study Identification

Unique Protocol Identification Number
NCT01067157
Brief Title
Long-term Effects of Lifestyle Intervention in Obesity and Genetic Influence
Acronym
LOGIC
Official Title
Long-term Effects of Lifestyle Intervention in Obesity and Genetic Influence in Children - LOGIC-Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2006 (Actual)
Primary Completion Date
December 31, 2013 (Actual)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
Collaborators
Rehabilitation clinic Schönsicht, 83471 Berchtesgaden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Cardiovascular Risk
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LOGIC
Intervention Description
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)
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Children without written consent from their parents. Children with monogenetic diseases with influence on obesity (e.g. Prader-Willi-Syndrome) or with secondary obesity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Halle, Prof. M.D.
Organizational Affiliation
Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich, Germany
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80992
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
16960161
Citation
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.
Results Reference
background
PubMed Identifier
18057335
Citation
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.
Results Reference
background
PubMed Identifier
18057339
Citation
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.
Results Reference
background
PubMed Identifier
19506565
Citation
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.
Results Reference
background
PubMed Identifier
19363514
Citation
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.
Results Reference
background
PubMed Identifier
15837955
Citation
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.
Results Reference
background
PubMed Identifier
19505623
Citation
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.
Results Reference
background
PubMed Identifier
34666255
Citation
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.
Results Reference
derived
PubMed Identifier
23434121
Citation
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.
Results Reference
derived
PubMed Identifier
22429873
Citation
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.
Results Reference
derived
Links:
URL
http://www.sport.med.tum.de
Description
Related Info
URL
http://www.klinikschoensicht.de
Description
Related Info

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

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