The Activity School in Finnmark for Overweight Children

Not Applicable

Completed

• Conditions: Obesity; Overweight

• Registration Number: NCT00872807
• Lead Sponsor: University Hospital of North Norway

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.

Study Timeline

• Study First Submitted: 2009-03-30
• Study First Submitted QC: 2009-03-30
• Study First Posted: 2009-03-31
• Study Start: 2009-04
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Last Update Submitted: 2014-12-11
• Last Update Posted: 2014-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Body Mass Index compared to baseline	3 years	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.

Secondary Outcome Measures

Name	Time	Method
Change in Body fat compared to baseline	3 years	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.
Change in activity level / Counts per min compared to baseline	3 years	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.
Change in triceps skinfold compared to baseline	3 years	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.
Change in self-concept compared to baseline	3 years	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.
Change in Systolic Blood Pressure compared to baseline	3 years	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.
Change in Homa Score / HOMA IR compared to baseline	3 years	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.
Change in psychiatric health compared to baseline	3 years	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.
Change in fitness from baseline	3 years	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.
Change in quality of life compared to baseline	3 years	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.
Change in Waist circumference compared to baseline	3 years	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.

Trial Locations

Locations (1)

Childrens departement Finnmark Hospital, Norway; 🇳🇴 Hammerfest, Norway