The Activity School in Finnmark for Overweight Children

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

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

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Behavioral: Lifestyle counseling in groups
* Behavioral: Individual intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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childhood, therapy, life style, motor activity, obesity, overweight, body mass index, treatment