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GRIB Forsoeget-2004

NCT ID: NCT00554645

Last Updated: 2007-11-07

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

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-11-30

Brief Summary

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The difficulties in loosing weight may not stem from lack og knowledge about nutrition, as implied by the standard treatment but from difficulties in following the advice. The hypothesis is, that revealing and addressing these difficulties psychotherapeutically may be more efficient in obtaining weight reduction. The effect of psychological group treatment of severely overweight children and their parents is compared with traditional nutritional information. In other words: Which is better: back-up or enlightenment?

Detailed Description

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At on-set the children get a medical examination, blood-tests, measurement of height, weight, skin-fold, waist and hip. Children and parents fill out questionnaires on social and educational background as well as motivation and expectations to the treatment. All Children are thereafter randomised into two groups:multi-disciplinary group intervention versus traditional information. The randomisation is stratified according to gender and degree of overweight (135%-145% and \>145%) supposing that the degree of overweight may mirror the difficulties in loosing weight. The experimental intervention consists of one lecture of general nutrition, weekly psychological group sessions for the children followed by physical exercise, and separate bi-monthly group sessions for the parents. After six months children and parents go to separate group sessions once a month for six months. The control group is offered nutritional advice once with a brief follow-up after one month. The height and weight of the children is measured every month, and the fat % is measured with DEXA-scanning at on-set, after six months, and after twelve months

Conditions

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Overweight

Keywords

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obesity children psychological intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Multi-disciplinary group intervention

Group Type EXPERIMENTAL

multi-disciplinary group intervention

Intervention Type BEHAVIORAL

children:weekley session in 6 months, monthly sessions for 6 months parents: bi-monthly sessions for 6 months, monthly sessions for 6 months

2

traditional information

Group Type ACTIVE_COMPARATOR

traditional information

Intervention Type OTHER

1 session of nutritional advise for parents and child and 1 follow-up after one month

Interventions

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multi-disciplinary group intervention

children:weekley session in 6 months, monthly sessions for 6 months parents: bi-monthly sessions for 6 months, monthly sessions for 6 months

Intervention Type BEHAVIORAL

traditional information

1 session of nutritional advise for parents and child and 1 follow-up after one month

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Weight compared to hight over 135% of the Danish norms (www.peadiatri.dk)

Exclusion Criteria

* None of the parents wants to participate
* Diagnosed somatic course of overweight
* Parents or children do not speak danish
* Sever physical handicap
* Psychiatric illness or mental retardation in children or parents
* Severe child abuse
* Siblings participation in the trail.
Minimum Eligible Age

10 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Den Sundhedsvidenskabelige Forskningsfond (Region 3)

UNKNOWN

Sponsor Role collaborator

Østdansk Sundhedsvidenskabeligt Forskningsforums Konsuletttjeneste

OTHER

Sponsor Role collaborator

Forskningspuljen

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Ole Andersen, dr. med.

Role: STUDY_CHAIR

former chief administration physician, peadiatrisk Enhed, Hilleroed Sygehus, 3400 Hilleroed

Locations

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Peaditrisk enhed, Helse vej 2

Hilleroed, Regionh, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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ø-2003-1-40

Identifier Type: -

Identifier Source: org_study_id