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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
  Purpose

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.


Condition Intervention
Obesity
Cardiovascular Risk
Behavioral: LOGIC

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Effects of Lifestyle Intervention in Obesity and Genetic Influence in Children - LOGIC-Study

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

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) [ Time Frame: 16 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: January 2006
Estimated Study Completion Date: July 2022
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)


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).

  Eligibility

Ages Eligible for Study:   6 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 mongenetic diseases with influence on obesity (e.g. Prader-Willi-Syndrom) or with secondary obesity.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067157

Contacts
Contact: Monika M. Siegrist, Ph.D. 0049/89289244- ext 48 siegrist@sport.med.tum.de

Locations
Germany
Department of Medicine, Division of Prevention and Sports Medicine, Technical University Munich, Germany Recruiting
Munic, Bavaria, Germany, 81675
Contact: Monika M. Siegrist, Ph.D    0049/89-289244- ext 48    siegrist@sport.med.tum.de   
Principal Investigator: Monika M. Siegrist, Ph.D.         
Sub-Investigator: Melanie Rank         
Sponsors and Collaborators
Technische Universität München
Klinik Schönsicht, Berchtesgaden, Germany
Investigators
Study Chair: Martin Halle, Prof. M.D. Department of Medicine, Division of Prevention and Sports Medicine, Technical University Munich, Germany
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01067157     History of Changes
Other Study ID Numbers: LOGIC
Study First Received: February 10, 2010
Last Updated: December 11, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
Obesity
overweight
childhood
adolescence
inpatient therapy
lifestyle intervention
cardiovascular risk
gene-lifestyle-interaction
Obesity and associated cardiovascular risk in childhood and adolescence,
health behaviour

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 19, 2014