NCT00554645

Brief Summary

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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2004

Typical duration for phase_2

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, 2004

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2007

Completed
Last Updated

November 7, 2007

Status Verified

November 1, 2007

First QC Date

November 5, 2007

Last Update Submit

November 5, 2007

Conditions

Overweight

Keywords

obesitychildrenpsychological intervention

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    Baseline, 6 months, 12 months

Secondary Outcomes (1)

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

    Baseline, 6 months, 12 months

Study Arms (2)

1

EXPERIMENTAL

Multi-disciplinary group intervention

Behavioral: multi-disciplinary group intervention

2

ACTIVE COMPARATOR

traditional information

Other: traditional information

Interventions

multi-disciplinary group interventionBEHAVIORAL

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

1
traditional informationOTHER

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

2

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peaditrisk enhed, Helse vej 2

Hilleroed, Regionh, 3400, Denmark

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ole Andersen, dr. med.

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 5, 2007

First Posted

November 7, 2007

Study Start

January 1, 2004

Study Completion

November 1, 2007

Last Updated

November 7, 2007

Record last verified: 2007-11

Locations

DK(1)