Long-term Effects of Lifestyle Intervention in Obesity and Genetic Influence (LOGIC)
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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 |
- 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 |
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| Contact: Monika M. Siegrist, Ph.D. | 0049/89289244- ext 48 | siegrist@sport.med.tum.de |
| 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 | |
| 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 Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013