The Activity School in Finnmark for Overweight Children

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Behavioral: Lifestyle counseling in groups; Behavioral: Individual intervention

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Hammerfest, Norway, 9600
    • Childrens departement Finnmark Hospital, Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group intervention; 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 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.; Behavioral: Individual intervention; Conventional lifestyle counseling individually by single health professionals, both in hospital and in municipality.
Active Comparator: Individual intervention; Lifestyle counseling for each separate family practiced by single health professionals both in hospital and municipality. A more conventional model.	Behavioral: Individual intervention; Conventional lifestyle counseling individually by single health professionals, both in hospital and in municipality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: The Royal Norwegian Ministry of Health; Finnmark Hospital Trust; Norwegian Foundation for Health and Rehabilitation; Norwegian Directorate of Health
• Investigators: Study Chair: Trond Flægstad, Professor, UNorth Norway

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: March 30, 2009
• First Submitted That Met QC Criteria: March 30, 2009
• First Posted (Estimate): March 31, 2009

Study Record Updates

• Last Update Posted (Estimate): December 12, 2014
• Last Update Submitted That Met QC Criteria: December 11, 2014
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: treatment; body mass index; obesity; overweight; childhood; therapy; motor activity; life style
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 2007/5.2006.3473 (REK); 15873 (NSD) (Other Identifier: Norwegian social science data services)