Treatment of Overweight Children and Adolescents

NCT ID: NCT00422916

Last Updated: 2016-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-12-31

Brief Summary

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The intervention program "Obeldicks light" is developed for overweight children aged 8-16 years. This intervention is gender - and age specific.

The 6-month intervention is based on nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality of structure, process and results of the intervention. 300 participants in a randomised controlled group design will be evaluated at 4 time points: baseline, end of intervention, 6 months after end of intervention and 12 months after end of intervention.Primary outcome measure is change of weight status as standard deviation score of BMI. Drop-outs will be interviewed to improve the intervention.

Detailed Description

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Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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intervention arm

Lifestyle Intervention based on Nutrition Treatment, exercise Treatment and behavorial treatment

Group Type EXPERIMENTAL

behavioral intervention

Intervention Type BEHAVIORAL

waiting list

waiting 6 months for Intervention without any intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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behavioral intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* overweight children

Exclusion Criteria

* primary disease
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bremen

OTHER

Sponsor Role collaborator

University of Witten/Herdecke

OTHER

Sponsor Role lead

Responsible Party

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Thomas Reinehr

Head of Department of Pediatric Endocrinology, Diabetes, and Nutrition Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Petra Kolip, Prof

Role: STUDY_CHAIR

University of Bremen, Germany

Locations

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Vestische Youth Hospital

Datteln, , Germany

Site Status

Countries

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Germany

References

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Reinehr T, Bucksch J, Muller A, Finne E, Kolip P. 7-Year follow-up of a lifestyle intervention in overweight children: Comparison to an untreated control group. Clin Nutr. 2018 Oct;37(5):1558-1562. doi: 10.1016/j.clnu.2017.08.017. Epub 2017 Aug 24.

Reference Type DERIVED
PMID: 28882396 (View on PubMed)

Finne E, Reinehr T, Schaefer A, Winkel K, Kolip P. Health-related quality of life in overweight German children and adolescents: do treatment-seeking youth have lower quality of life levels? Comparison of a clinical sample with the general population using a multilevel model approach. BMC Public Health. 2013 Jun 8;13:561. doi: 10.1186/1471-2458-13-561.

Reference Type DERIVED
PMID: 23759033 (View on PubMed)

Finne E, Reinehr T, Schaefer A, Winkel K, Kolip P. Changes in self-reported and parent-reported health-related quality of life in overweight children and adolescents participating in an outpatient training: findings from a 12-month follow-up study. Health Qual Life Outcomes. 2013 Jan 2;11:1. doi: 10.1186/1477-7525-11-1.

Reference Type DERIVED
PMID: 23281620 (View on PubMed)

Reinehr T, Schaefer A, Winkel K, Finne E, Toschke AM, Kolip P. An effective lifestyle intervention in overweight children: findings from a randomized controlled trial on "Obeldicks light". Clin Nutr. 2010 Jun;29(3):331-6. doi: 10.1016/j.clnu.2009.12.010. Epub 2010 Jan 27.

Reference Type DERIVED
PMID: 20106567 (View on PubMed)

Other Identifiers

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GFEL011174505

Identifier Type: -

Identifier Source: org_study_id

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