Long-term Effects of Lifestyle Intervention in Obesity and Genetic Influence (LOGIC)
|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|
- 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 ]
|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)|
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)
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067157
|Contact: Monika M. Siegrist, Ph.D.||0049/89289244- ext email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Monika M. Siegrist, Ph.D.|
|Sub-Investigator: Melanie Rank|
|Study Chair:||Martin Halle, Prof. M.D.||Department of Medicine, Division of Prevention and Sports Medicine, Technical University Munich, Germany|