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Completed

NCT Number: NCT00554645

GRIB Forsoeget-2004

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?

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peaditrisk enhed, Helse vej 2

Hilleroed, Regionh, 3400, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

multi-disciplinary group intervention

Behavioral

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

traditional information

Other

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

Primary outcomes

  1. Body Mass Index

    Time frame: Baseline, 6 months, 12 months

Secondary outcomes

  1. fat% measured by DEXA scan, Hip/waist ratio, skinfold

    Time frame: Baseline, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

Forskningspuljen

Other Gov

Collaborators

  • Den Sundhedsvidenskabelige Forskningsfond (Region 3)
  • Østdansk Sundhedsvidenskabeligt Forskningsforums Konsuletttjeneste

Registry information

Official study title

Multi-Disciplinary Group Intervention Versus Traditional Information Towards Severely Overweight Children and Their Families -

Acronym: GRIB-2004

Important dates

Study start
2004
Study completion
2007
First posted
Nov 7, 2007
Registry last updated
Nov 7, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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