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GRIB Forsoeget-2004 (GRIB-2004)

F

Forskningspuljen

Status and phase

Completed
Phase 2

Conditions

Overweight

Treatments

Behavioral: multi-disciplinary group intervention
Other: traditional information

Study type

Interventional

Funder types

Other

Identifiers

NCT00554645
ø-2003-1-40

Details and patient eligibility

About

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?

Full description

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

Enrollment

45 patients

Sex

All

Ages

10 to 15 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 2 patient groups

1
Experimental group
Description:
Multi-disciplinary group intervention
Treatment:
Behavioral: multi-disciplinary group intervention
2
Active Comparator group
Description:
traditional information
Treatment:
Other: traditional information

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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