Long-term Effects of Lifestyle Intervention in Obesity and Genetic Influence (LOGIC)
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|ClinicalTrials.gov Identifier: NCT01067157|
Recruitment Status : Active, not recruiting
First Posted : February 11, 2010
Last Update Posted : September 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obesity Cardiovascular Risk||Behavioral: LOGIC||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-term Effects of Lifestyle Intervention in Obesity and Genetic Influence in Children - LOGIC-Study|
|Actual Study Start Date :||January 1, 2006|
|Actual Primary Completion Date :||December 31, 2013|
|Estimated Study Completion Date :||July 2022|
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.
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)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067157
|Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich, Germany|
|Munich, Bavaria, Germany, 80992|
|Study Chair:||Martin Halle, Prof. M.D.||Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich, Germany|