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ObesityLOGICNCT01067157

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

A study testing LOGIC in people with Obesity and Cardiovascular Risk, run by Technical University of Munich at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 19 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Cardiovascular Risk
What is being tested?
LOGIC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,500 participants
Where
1 siteGermany
Study dates
1 Jan 2006to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich, Germany

    Munich, Bavaria, 80992

Other trials in Germany

About this study

Official title: Long-term Effects of Lifestyle Intervention in Obesity and Genetic Influence in Children - LOGIC-Study

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.

Read the 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).

Being tested
LOGIC
Keywords
Obesity, overweight, childhood, adolescence, inpatient therapy, lifestyle intervention, cardiovascular risk, gene-lifestyle-interaction, Obesity and associated cardiovascular risk in childhood and adolescence,, health behaviour
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LOGICBehavioural

    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)

Study groups in NCT01067157
Study groupRoleWhat they receive
AOtherOther = 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.
Receives: Behavioral: LOGIC

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 16 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2010 (estimated)
  2. Study start1 Jan 2006
  3. Primary completion31 Dec 2013
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01067157
Sponsor's protocol ID
LOGIC
Acronym
LOGIC
Status last verified
Nov 2023
First submitted
10 Feb 2010
Last updated
30 Nov 2023
Results posted
No
Data monitoring committee
No

Publications

  • Reinehr T, de Sousa G, Toschke AM, Andler W. Long-term follow-up of cardiovascular disease risk factors in children after an obesity intervention. Am J Clin Nutr. 2006 Sep;84(3):490-6. doi: 10.1093/ajcn/84.3.490.

    PubMed 16960161

  • Baker JL, Olsen LW, Sorensen TI. Childhood body-mass index and the risk of coronary heart disease in adulthood. N Engl J Med. 2007 Dec 6;357(23):2329-37. doi: 10.1056/NEJMoa072515.

    PubMed 18057335

  • Bibbins-Domingo K, Coxson P, Pletcher MJ, Lightwood J, Goldman L. Adolescent overweight and future adult coronary heart disease. N Engl J Med. 2007 Dec 6;357(23):2371-9. doi: 10.1056/NEJMsa073166.

    PubMed 18057339

  • Owen CG, Whincup PH, Orfei L, Chou QA, Rudnicka AR, Wathern AK, Kaye SJ, Eriksson JG, Osmond C, Cook DG. Is body mass index before middle age related to coronary heart disease risk in later life? Evidence from observational studies. Int J Obes (Lond). 2009 Aug;33(8):866-77. doi: 10.1038/ijo.2009.102. Epub 2009 Jun 9.

    PubMed 19506565

  • Birch LL, Ventura AK. Preventing childhood obesity: what works? Int J Obes (Lond). 2009 Apr;33 Suppl 1:S74-81. doi: 10.1038/ijo.2009.22.

    PubMed 19363514

  • Daniels SR, Arnett DK, Eckel RH, Gidding SS, Hayman LL, Kumanyika S, Robinson TN, Scott BJ, St Jeor S, Williams CL. Overweight in children and adolescents: pathophysiology, consequences, prevention, and treatment. Circulation. 2005 Apr 19;111(15):1999-2012. doi: 10.1161/01.CIR.0000161369.71722.10.

    PubMed 15837955

  • McCall A, Raj R. Exercise for prevention of obesity and diabetes in children and adolescents. Clin Sports Med. 2009 Jul;28(3):393-421. doi: 10.1016/j.csm.2009.03.001.

    PubMed 19505623

  • Siegrist M, Heitkamp M, Braun I, Vogg N, Haller B, Langhof H, Koenig W, Halle M. Changes of omentin-1 and chemerin during 4 weeks of lifestyle intervention and 1 year follow-up in children with obesity. Clin Nutr. 2021 Nov;40(11):5648-5654. doi: 10.1016/j.clnu.2021.09.042. Epub 2021 Oct 8.

    PubMed 34666255

  • Rank M, Siegrist M, Wilks DC, Langhof H, Wolfarth B, Haller B, Koenig W, Halle M. The cardio-metabolic risk of moderate and severe obesity in children and adolescents. J Pediatr. 2013 Jul;163(1):137-42. doi: 10.1016/j.jpeds.2013.01.020. Epub 2013 Feb 20.

    PubMed 23434121

  • Rank M, Siegrist M, Wilks DC, Haller B, Wolfarth B, Langhof H, Halle M. Long-term effects of an inpatient weight-loss program in obese children and the role of genetic predisposition-rationale and design of the LOGIC-trial. BMC Pediatr. 2012 Mar 19;12:30. doi: 10.1186/1471-2431-12-30.

    PubMed 22429873

Questions about this trial

What is this clinical trial studying?

A study testing LOGIC in people with Obesity and Cardiovascular Risk, run by Technical University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01067157, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.

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