The Activity School in Finnmark for Overweight Children

Obesity Clinical Trial

Official title:

The Activity School in Finnmark for Overweight and Obese Children and Their Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872807
• Other study ID #: 2007/5.2006.3473 (REK)
• Secondary ID: 15873 (NSD)
• Status: Completed
• Phase: N/A
• First received: March 30, 2009
• Last updated: December 11, 2014
• Start date: April 2009
• Est. completion date: December 2013

Study information

• Verified date: December 2012
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Lifestyle counseling in groups
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.
• Individual intervention
Conventional lifestyle counseling individually by single health professionals, both in hospital and in municipality.

Locations

Country	Name	City	State
Norway	Childrens departement Finnmark Hospital, Norway	Hammerfest

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital of North Norway	Finnmark Hospital Trust, Norway, Norwegian Directorate of Health, Norwegian Foundation for Health and Rehabilitation, The Royal Norwegian Ministry of Health

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Kokkvoll A, Grimsgaard S, Ødegaard R, Flægstad T, Njølstad 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. E — View Citation

Kokkvoll A, Grimsgaard S, Steinsbekk S, Flægstad T, Njølstad 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in lipid levels compared to baseline	Measurements of total cholesterol, Triglycerides, HDL and LDL at baseline, 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 counseling and active treatment has stopped, 3 years from baseline	3 years	No
Primary	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	No
Secondary	Change in Systolic Blood Pressure compared to baseline	Measured with an automated blood pressure monitor at baseline, at 3 months- , 1 year-, 2 year- and 3-year follow-up. Primary measures at the end (2 years) of continuous lifestyle modification. Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.	3 years	No
Secondary	Change in Body fat compared to baseline	Measured with bioelectrical impedance analysis 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 counseling and active treatment has stopped, 3 years from baseline.	3 years	No
Secondary	Change in activity level / Counts per min compared to baseline	Measured with accelerometers at baseline, 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 counseling and active treatment has stopped, 3 years from baseline.	3 years	No
Secondary	Change in Waist circumference compared to baseline	Measured with measuring tape mid-point between the lowest rib and the top of the iliac crest at baseline, 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 counseling and active treatment stopped, 3 years from baseline.	3 years	No
Secondary	Change in Homa Score / HOMA IR compared to baseline	Homa score calculated from the cross product of fasting plasma insulin and plasma glucose divided with a factor of 22.5. Fasting plasma insulin and glucose will be measured at baseline, at 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 counseling and active treatment has stopped, 3 years from baseline.	3 years	No
Secondary	Change in triceps skinfold compared to baseline	Measured with Holtain Tanner /Whitehouse Skinfold Caliper at baseline,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 counseling and active treatment has stopped, 3 years from baseline.	3 years	No
Secondary	Change in self-concept compared to baseline	Measured with SPPC, Self Perception Profile for Children at baseline, at 6 months- , 1 year-, 2 year- and 3-year follow-up. Primary outcome measured at 2 years of continuous lifestyle modification. Last measurement at 1 year after last counseling and active treatment has stopped.	3 years	Yes
Secondary	Change in psychiatric health compared to baseline	Measured with Strengths and difficulties Questionnaire ( SDQ-S)at baseline, at 6 months- , 1 year-, 2 year- and 3-year follow-up. Primary measurement at 2 years of continuous lifestyle modification. Last measurement at 1 year after last counseling and active treatment has stopped.	3 years	Yes
Secondary	Change in fitness from baseline	Measured with Andersen's test (shuttle test) at baseline, 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 counseling and active treatment has stopped, 3 years from baseline.	3 years	No
Secondary	Change in quality of life compared to baseline	Measured with KINDL (Kinder Lebensqualitet Fragebogen) at baseline, 6 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 counseling and active treatment has stopped, 3 years from baseline.	3 years	Yes