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ObesityObeldicksNCT00435734

Obesity Intervention "Obeldicks" for Obese Children, Adolescents and Their Parents

An observational study of Obesity, run by University of Witten/Herdecke at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The intervention program "Obeldicks" was developed for obese children aged 6 to 16 years. This intervention is gender- and age specific. The 12-months intervention is based on nutrition course, behaviour therapy and exercise therapy. Read more about this study

Who is it for?
Ages 6 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
obesity intervention
How many people
4,000 participants
Where
1 siteGermany
Study dates
Jul 1999to Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: clinic based study of obese children

Who may be able to join

  • BMI> 97. percentile for age and gender

Who cannot join

  • Psychiatric disorders
  • Endocrine disorders

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Vestische Children´s Hospital

    Datteln, 45711

Other trials in Germany

About this study

Official title: Evaluation of the Intervention Program "Obeldicks" for Obese Children and Adolescents

The intervention program "Obeldicks" was developed for obese children aged 6 to 16 years. This intervention is gender- and age specific. The 12-months intervention is based on nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality of structure, process and results of the intervention. Primary outcome measure is change of weight status as standard deviation score of BMI. Furthermore, cardiovascular risk factor profile, hormones (e.g. iGF-I, thyroid hormones, vitamin D status)adipocytokines, GI- hormones, intima media thickness are measured prior to and after the one-year intervention. The changes of these hormones and adipocytokines will allow to answer the questions whether the alterations of these hormones are a cause or consequence of overweight. Additionally, a genetic screening is performed to characterize the participants to probably predict response to intervention.

Conditions
Obesity
Being tested
obesity intervention
Medical subject headings
Obesity

What participants receive

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

  • obesity interventionBehavioural

What is being measured

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

  1. change of BMI-SDS

    Measured: 20 years

Secondary outcomes (5)

  1. change of GI hormones

    Measured: 10 years

  2. change of adipocytokines

    Measured: 10 years

  3. change of cardiovascualr risk factors

    Measured: 10 years

  4. change of metabolomics

    Measured: 10 years

  5. change of psychological variables

    Measured: 10 years

Timeline

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

  1. First posted15 Feb 2007 (estimated)
  2. Study startJul 1999
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00435734
Sponsor's protocol ID
GFEL011174506
Acronym
Obeldicks
Status last verified
Nov 2020
First submitted
14 Feb 2007
Last updated
5 Nov 2020
Results posted
No

Publications

  • Reinehr T, Kulle A, Barth A, Ackermann J, Lass N, Holterhus PM. Sex Hormone Profile in Pubertal Boys With Gynecomastia and Pseudogynecomastia. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgaa044. doi: 10.1210/clinem/dgaa044.

    PubMed 31996898

  • Rothermel J, Lass N, Barth A, Reinehr T. Link between omentin-1, obesity and insulin resistance in children: Findings from a longitudinal intervention study. Pediatr Obes. 2020 May;15(5):e12605. doi: 10.1111/ijpo.12605. Epub 2019 Dec 16.

    PubMed 31840425

  • Reinehr T, Bosse C, Lass N, Rothermel J, Knop C, Roth CL. Effect of Weight Loss on Puberty Onset in Overweight Children. J Pediatr. 2017 May;184:143-150.e1. doi: 10.1016/j.jpeds.2017.01.066. Epub 2017 Feb 24.

    PubMed 28238482

  • Reinehr T, Lass N, Toschke C, Rothermel J, Lanzinger S, Holl RW. Which Amount of BMI-SDS Reduction Is Necessary to Improve Cardiovascular Risk Factors in Overweight Children? J Clin Endocrinol Metab. 2016 Aug;101(8):3171-9. doi: 10.1210/jc.2016-1885. Epub 2016 Jun 10.

    PubMed 27285295

  • Hellmuth C, Kirchberg FF, Lass N, Harder U, Peissner W, Koletzko B, Reinehr T. Tyrosine Is Associated with Insulin Resistance in Longitudinal Metabolomic Profiling of Obese Children. J Diabetes Res. 2016;2016:2108909. doi: 10.1155/2016/2108909. Epub 2015 Dec 21.

    PubMed 26881241

  • Reinehr T, Elfers C, Lass N, Roth CL. Irisin and its relation to insulin resistance and puberty in obese children: a longitudinal analysis. J Clin Endocrinol Metab. 2015 May;100(5):2123-30. doi: 10.1210/jc.2015-1208. Epub 2015 Mar 17.

    PubMed 25781361

  • Reinehr T, Wolters B, Knop C, Lass N, Holl RW. Strong effect of pubertal status on metabolic health in obese children: a longitudinal study. J Clin Endocrinol Metab. 2015 Jan;100(1):301-8. doi: 10.1210/jc.2014-2674.

    PubMed 25243573

  • Reinehr T, Wolters B, Roth CL, Hinney A. FTO gene: association to weight regain after lifestyle intervention in overweight children. Horm Res Paediatr. 2014;81(6):391-6. doi: 10.1159/000358328. Epub 2014 May 7.

    PubMed 24819256

  • Reinehr T, Kulle A, Wolters B, Knop C, Lass N, Welzel M, Holterhus PM. Relationships between 24-hour urinary free cortisol concentrations and metabolic syndrome in obese children. J Clin Endocrinol Metab. 2014 Jul;99(7):2391-9. doi: 10.1210/jc.2013-4398. Epub 2014 Mar 26.

    PubMed 24670085

  • Roth CL, Hinney A, Schur EA, Elfers CT, Reinehr T. Association analyses for dopamine receptor gene polymorphisms and weight status in a longitudinal analysis in obese children before and after lifestyle intervention. BMC Pediatr. 2013 Nov 27;13:197. doi: 10.1186/1471-2431-13-197.

    PubMed 24283216

  • Uysal Y, Wolters B, Knop C, Reinehr T. Components of the metabolic syndrome are negative predictors of weight loss in obese children with lifestyle intervention. Clin Nutr. 2014 Aug;33(4):620-5. doi: 10.1016/j.clnu.2013.09.007. Epub 2013 Sep 18.

    PubMed 24075648

  • Reinehr T, Kulle A, Wolters B, Lass N, Welzel M, Riepe F, Holterhus PM. Steroid hormone profiles in prepubertal obese children before and after weight loss. J Clin Endocrinol Metab. 2013 Jun;98(6):E1022-30. doi: 10.1210/jc.2013-1173. Epub 2013 May 23.

    PubMed 23703723

  • Volckmar AL, Putter C, Song JY, Graniger J, Knoll N, Wolters B, Hebebrand J, Scherag A, Reinehr T, Hinney A. Analyses of non-synonymous obesity risk alleles in SH2B1 (rs7498665) and APOB48R (rs180743) in obese children and adolescents undergoing a 1-year lifestyle intervention. Exp Clin Endocrinol Diabetes. 2013 Jun;121(6):334-7. doi: 10.1055/s-0033-1334875. Epub 2013 Mar 21.

    PubMed 23519644

  • Reinehr T, Wunsch R, Putter C, Scherag A. Relationship between carotid intima-media thickness and metabolic syndrome in adolescents. J Pediatr. 2013 Aug;163(2):327-32. doi: 10.1016/j.jpeds.2013.01.032. Epub 2013 Feb 26.

    PubMed 23485031

  • Wolters B, Lass N, Reinehr T. TSH and free triiodothyronine concentrations are associated with weight loss in a lifestyle intervention and weight regain afterwards in obese children. Eur J Endocrinol. 2013 Feb 15;168(3):323-9. doi: 10.1530/EJE-12-0981. Print 2013 Mar.

    PubMed 23211576

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by University of Witten/Herdecke 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 1 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2020. 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?

This study is still under way. Results are not available in the source record yet.

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?

change of BMI-SDS (time frame: 20 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 NCT00435734, which also lists 43 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 5 Nov 2020.

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