GRIB Forsoeget-2004 | NCT00554645

Studies
GRIB Forsoeget-2004

NCT00554645

Sponsor

Forskningspuljen

Status

Completed

Last Update Posted

Nov 7, 2007Estimated

Enrollment

45Actual

Phase

Phase 2

Conditions

Overweight

Interventions

multi-disciplinary group intervention
traditional information

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Nov 2007Actual

First Submitted Date

Nov 5, 2007

First Submission Date that Met QC Criteria

Nov 5, 2007

First Posted Date

Nov 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2007

Last Update Posted Date

Nov 7, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

ForskningspuljenOTHER_GOV

Collaborators

Name	Class
Den Sundhedsvidenskabelige Forskningsfond (Region 3)	UNKNOWN
Østdansk Sundhedsvidenskabeligt Forskningsforums Konsuletttjeneste	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

Detailed 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Multi-disciplinary group intervention	Behavioral: multi-disciplinary group intervention
2	Active Comparator	traditional information	Other: traditional information

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body Mass Index		Baseline, 6 months, 12 months

Secondary Outcomes

Measure	Description	Time Frame
fat% measured by DEXA scan, Hip/waist ratio, skinfold		Baseline, 6 months, 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ole Andersen, dr. med.	former chief administration physician, peadiatrisk Enhed, Hilleroed Sygehus, 3400 Hilleroed	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peaditrisk enhed, Helse vej 2		Hilleroed	Regionh	3400	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight
D009765	Obesity

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided