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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Technische Universität München
Sponsor:
Collaborator:
Klinik Schönsicht, Berchtesgaden, Germany
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01067157
First received: February 10, 2010
Last updated: December 11, 2012
Last verified: December 2012

February 10, 2010
December 11, 2012
January 2006
December 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT01067157 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Long-term Effects of Lifestyle Intervention in Obesity and Genetic Influence
Long-term Effects of Lifestyle Intervention in Obesity and Genetic Influence in Children - LOGIC-Study

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.

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).

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Cardiovascular Risk
Behavioral: 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)

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.

Intervention: Behavioral: LOGIC

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
July 2022
December 2013   (final data collection date for primary outcome measure)

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 mongenetic diseases with influence on obesity (e.g. Prader-Willi-Syndrom) or with secondary obesity.
Both
6 Years to 19 Years
Yes
Contact: Monika M. Siegrist, Ph.D. 0049/89289244- ext 48 siegrist@sport.med.tum.de
Germany
 
NCT01067157
LOGIC
No
Technische Universität München
Technische Universität München
Klinik Schönsicht, Berchtesgaden, Germany
Study Chair: Martin Halle, Prof. M.D. Department of Medicine, Division of Prevention and Sports Medicine, Technical University Munich, Germany
Technische Universität München
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP