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

Technical University of Munich

Status: Completed

Conditions: Obesity; Cardiovascular Risk

Treatments: Behavioral: LOGIC

Study type: Interventional

Funder types: Other

Identifiers

NCT01067157

LOGIC

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,500 patients

Sex: All

Ages: 6 to 19 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,500 participants in 1 patient group

A

Other group

Description:

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.

Treatment:

Behavioral: LOGIC