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

Sponsor
Technische Universität München (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01067157
Collaborator
Rehabilitation clinic Schönsicht, 83471 Berchtesgaden (Other)
1,500
1
1
197.9
7.6

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: LOGIC
N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
1500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Long-term Effects of Lifestyle Intervention in Obesity and Genetic Influence in Children - LOGIC-Study
Actual Study Start Date :
Jan 1, 2006
Actual Primary Completion Date :
Dec 31, 2013
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: 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)

Outcome Measures

Primary Outcome Measures

  1. 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) [16 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 19 Years
Sexes Eligible for Study:
All
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 monogenetic diseases with influence on obesity (e.g. Prader-Willi-Syndrome) or with secondary obesity.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich, Germany Munich Bavaria Germany 80992

Sponsors and Collaborators

  • Technische Universität München
  • Rehabilitation clinic Schönsicht, 83471 Berchtesgaden

Investigators

  • Study Chair: Martin Halle, Prof. M.D., Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich, Germany

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01067157
Other Study ID Numbers:
  • LOGIC
First Posted:
Feb 11, 2010
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022

Study Results

No Results Posted as of May 24, 2022