NCT00422916

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

2.9 years

First QC Date

January 16, 2007

Last Update Submit

October 24, 2016

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

  • change of weight status

    6 months

Secondary Outcomes (2)

  • Change of eating and exercise behaviour

    6 months

  • change of quality of life

    6 months

Study Arms (2)

intervention arm

EXPERIMENTAL

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

Behavioral: behavioral intervention

waiting list

NO INTERVENTION

waiting 6 months for Intervention without any intervention

Interventions

behavioral interventionBEHAVIORAL
intervention arm

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • overweight children

You may not qualify if:

  • primary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestische Youth Hospital

Datteln, 45711, Germany

Location

Related Publications (4)

  • 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.

    PMID: 28882396DERIVED

  • 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.

    PMID: 23759033DERIVED

  • 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.

    PMID: 23281620DERIVED

  • 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.

    PMID: 20106567DERIVED

MeSH Terms

Conditions

Overweight

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Petra Kolip, Prof

    University of Bremen, Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Pediatric Endocrinology, Diabetes, and Nutrition Medicine

Study Record Dates

First Submitted

January 16, 2007

First Posted

January 17, 2007

Study Start

January 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations

DE(1)