NCT00872807

Brief Summary

The purpose of this study is to evaluate the effectiveness of a life style counseling programme designed for overweight and obese children and their parents in groups compared to traditional individual counseling in the pediatric outpatient clinic and the community. The two interventions are both hospital and community based.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable obesity

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

First Submitted

Initial submission to the registry

March 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 12, 2014

Status Verified

December 1, 2012

Enrollment Period

3.7 years

First QC Date

March 30, 2009

Last Update Submit

December 11, 2014

Conditions

Keywords

childhoodtherapylife stylemotor activityobesityoverweightbody mass indextreatment

Outcome Measures

Primary Outcomes (1)

  • Change in Body Mass Index compared to baseline

    BMI will be measured at baseline and at 3 months- , 1 year-, 2 year- and 3-year follow-up. Primary measures at 2 years of continuous lifestyle modification. Last measurement at 1 year after last counselling and active treatment has stopped, 3 years from baseline.

    3 years

Secondary Outcomes (10)

  • Change in Systolic Blood Pressure compared to baseline

    3 years

  • Change in Body fat compared to baseline

    3 years

  • Change in activity level / Counts per min compared to baseline

    3 years

  • Change in Waist circumference compared to baseline

    3 years

  • Change in Homa Score / HOMA IR compared to baseline

    3 years

  • +5 more secondary outcomes

Other Outcomes (1)

  • Change in lipid levels compared to baseline

    3 years

Study Arms (2)

Group intervention

EXPERIMENTAL

Lifestyle counseling (physical activity and dietary modification) in groups both at the hospital and in their own municipality. They meet a multidisciplinary team, receive organized physical activity in the municipality and are invited to a 3 days camp after 4-6 months.

Behavioral: Lifestyle counseling in groupsBehavioral: Individual intervention

Individual intervention

ACTIVE COMPARATOR

Lifestyle counseling for each separate family practiced by single health professionals both in hospital and municipality. A more conventional model.

Behavioral: Individual intervention

Interventions

The activity school in Finnmark. Lifestyle counseling (physical activity and dietary modification) in groups both at the hospital and in their own municipality. They meet a multidisciplinary team, receive organized physical activity in the municipality and are invited to a 3 days camp after 4-6 months.

Group intervention

Conventional lifestyle counseling individually by single health professionals, both in hospital and in municipality.

Group interventionIndividual intervention

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Overweight or obese.
  • BMI \> IOTF (International Obesity TaskForce) cut-points 27,5. kg/ m2.

You may not qualify if:

  • Diseases not compatible with normal physical activity.
  • Disorders not compatible with group treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens departement Finnmark Hospital, Norway

Hammerfest, Hammerfest, 9600, Norway

Location

Related Publications (3)

  • Kokkvoll A, Grimsgaard S, Odegaard R, Flaegstad T, Njolstad I. Single versus multiple-family intervention in childhood overweight--Finnmark Activity School: a randomised trial. Arch Dis Child. 2014 Mar;99(3):225-31. doi: 10.1136/archdischild-2012-303571. Epub 2013 Dec 11.

  • Kokkvoll A, Grimsgaard S, Steinsbekk S, Flaegstad T, Njolstad I. Health in overweight children: 2-year follow-up of Finnmark Activity School--a randomised trial. Arch Dis Child. 2015 May;100(5):441-8. doi: 10.1136/archdischild-2014-307107. Epub 2014 Nov 20.

  • Kokkvoll AS, Grimsgaard S, Flaegstad T, Andersen LB, Ball GDC, Wilsgaard T, Njolstad I. No additional long-term effect of group vs individual family intervention in the treatment of childhood obesity-A randomised trial. Acta Paediatr. 2020 Jan;109(1):183-192. doi: 10.1111/apa.14916. Epub 2019 Jul 30.

MeSH Terms

Conditions

ObesityOverweightMotor Activity

Interventions

Population Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Trond Flægstad, Professor

    UNorth Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2009

First Posted

March 31, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

December 12, 2014

Record last verified: 2012-12

Locations