Clinical trial NCT00872807: The Activity School in Finnmark for Overweight Children
Official title: The Activity School in Finnmark for Overweight and Obese Children and Their Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: childhood
therapy
life style
motor activity
obesity
overweight
body mass index
treatment
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Finnmark Hospital Trust
name: The Royal Norwegian Ministry of Health
name: Norwegian Foundation for Health and Rehabilitation
name: Norwegian Directorate of Health
First posted: 2009-03-31
Enrollment: 97
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Randomized study design with two parallel groups.Active intervention in two years, last follow-up after 3 years.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Body Mass Index compared to baseline
timeFrame: 3 years
Secondary outcomes:
measure: Change in Systolic Blood Pressure compared to baseline
timeFrame: 3 years
measure: Change in Body fat compared to baseline
timeFrame: 3 years
measure: Change in activity level / Counts per min compared to baseline
timeFrame: 3 years
measure: Change in Waist circumference compared to baseline
timeFrame: 3 years
measure: Change in Homa Score / HOMA IR compared to baseline
timeFrame: 3 years
measure: Change in triceps skinfold compared to baseline
timeFrame: 3 years
measure: Change in self-concept compared to baseline
timeFrame: 3 years
measure: Change in psychiatric health compared to baseline
timeFrame: 3 years
measure: Change in fitness from baseline
timeFrame: 3 years
measure: Change in quality of life compared to baseline
timeFrame: 3 years
Other outcomes:
measure: Change in lipid levels compared to baseline
timeFrame: 3 years
Locations:
city: Hammerfest
country: Norway
facility: Childrens departement Finnmark Hospital, Norway
Study officials:
affiliation: UNorth Norway
name: Trond Flægstad, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.