Obesity Intervention "Obeldicks" for Obese Children, Adol... | NCT00435734

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

NCT00435734

Sponsor

University of Witten/Herdecke

Status

Active, not recruiting

Last Update Posted

Nov 5, 2020Actual

Enrollment

4,000Actual

Phase

Not provided

Conditions

Obesity

Interventions

obesity intervention

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1999

Primary Completion Date

Dec 2030Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Feb 14, 2007

First Submission Date that Met QC Criteria

Feb 14, 2007

First Posted Date

Feb 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2020

Last Update Posted Date

Nov 5, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thomas Reinehr, Head of Department of Pediatric Endocrinology Diabetes and Nutrition Medicine, University of Witten/HerdeckePrincipal Investigator

Lead Sponsor

University of Witten/HerdeckeOTHER

Collaborators

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

4,000Actual

Name	Type	Description	Arm Group Labels	Other Names
obesity intervention	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of BMI-SDS		20 years

Secondary Outcomes

Measure	Description	Time Frame
change of GI hormones		10 years
change of adipocytokines		10 years
change of cardiovascualr risk factors

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI> 97. percentile for age and gender

Exclusion Criteria:

Psychiatric disorders
Endocrine disorders

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

clinic based study of obese children

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Reinehr	Vestische Children´s Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vestische Children´s Hospital		Datteln		45711	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31996898	Derived	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.
31840425	Derived	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.

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases