Back to resultsThe Activity School in Finnmark for Overweight Children
Primary Purpose
Obesity, Overweight
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Lifestyle counseling in groups
Individual intervention
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring childhood, therapy, life style, motor activity, obesity, overweight, body mass index, treatment
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.
Sites / Locations
- Childrens departement Finnmark Hospital, Norway
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group intervention
Individual intervention
Arm Description
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.
Lifestyle counseling for each separate family practiced by single health professionals both in hospital and municipality. A more conventional model.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT00872807
First Posted
March 30, 2009
Last Updated
December 11, 2014
Sponsor
University Hospital of North Norway
Collaborators
Finnmark Hospital Trust, The Royal Norwegian Ministry of Health, Norwegian Foundation for Health and Rehabilitation, Norwegian Directorate of Health
1. Study Identification
Unique Protocol Identification Number
NCT00872807
Brief Title
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
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
Collaborators
Finnmark Hospital Trust, The Royal Norwegian Ministry of Health, Norwegian Foundation for Health and Rehabilitation, Norwegian Directorate of Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
childhood, therapy, life style, motor activity, obesity, overweight, body mass index, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Individual intervention
Arm Type
Active Comparator
Arm Description
Lifestyle counseling for each separate family practiced by single health professionals both in hospital and municipality. A more conventional model.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling in groups
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individual intervention
Intervention Description
Conventional lifestyle counseling individually by single health professionals, both in hospital and in municipality.
Primary Outcome Measure Information:
Title
Change in Body Mass Index compared to baseline
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Change in Systolic Blood Pressure compared to baseline
Description
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.
Time Frame
3 years
Title
Change in Body fat compared to baseline
Description
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.
Time Frame
3 years
Title
Change in activity level / Counts per min compared to baseline
Description
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.
Time Frame
3 years
Title
Change in Waist circumference compared to baseline
Description
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.
Time Frame
3 years
Title
Change in Homa Score / HOMA IR compared to baseline
Description
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.
Time Frame
3 years
Title
Change in triceps skinfold compared to baseline
Description
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.
Time Frame
3 years
Title
Change in self-concept compared to baseline
Description
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.
Time Frame
3 years
Title
Change in psychiatric health compared to baseline
Description
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.
Time Frame
3 years
Title
Change in fitness from baseline
Description
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.
Time Frame
3 years
Title
Change in quality of life compared to baseline
Description
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.
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
Change in lipid levels compared to baseline
Description
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
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trond Flægstad, Professor
Organizational Affiliation
UNorth Norway
Official's Role
Study Chair
Facility Information:
Facility Name
Childrens departement Finnmark Hospital, Norway
City
Hammerfest
ZIP/Postal Code
9600
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
24336385
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.
Results Reference
result
PubMed Identifier
25414250
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.
Results Reference
result
PubMed Identifier
31240752
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.
Results Reference
derived
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The Activity School in Finnmark for Overweight Children
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