The Activity School in Finnmark for Overweight Children

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Finnmark Hospital Trust, Norway
The Royal Norwegian Ministry of Health
Norwegian Foundation for Health and Rehabilitation
Norwegian Directorate of Health
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT00872807
First received: March 30, 2009
Last updated: December 4, 2012
Last verified: December 2012

March 30, 2009
December 4, 2012
April 2009
December 2012   (final data collection date for primary outcome measure)
Change in Body Mass Index compared to baseline [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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.
Change in Body Mass Index (BMI) [ Time Frame: After 2 years, last control after 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00872807 on ClinicalTrials.gov Archive Site
  • Change in Systolic Blood Pressure compared to baseline [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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.
  • Quality of life [ Time Frame: After 2 years, last control after 3 years ] [ Designated as safety issue: Yes ]
  • Measures of metabolic changes [ Time Frame: After 2 years, last control after 3 years ] [ Designated as safety issue: No ]
  • Measures of body fat distribution [ Time Frame: After 2 years, last control after 3 years ] [ Designated as safety issue: No ]
  • Change in weekly activity level [ Time Frame: After 2 years, last control after 3 years ] [ Designated as safety issue: No ]
Change in lipid levels compared to baseline [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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
Not Provided
 
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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Obesity
  • Overweight
  • 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.
  • 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.
    Interventions:
    • Behavioral: Lifestyle counseling in groups
    • Behavioral: Individual intervention
  • Active Comparator: Individual intervention
    Lifestyle counseling for each separate family practiced by single health professionals both in hospital and municipality. A more conventional model.
    Intervention: Behavioral: Individual intervention
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. Epub 2013 Dec 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
97
December 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00872807
2007/5.2006.3473 (REK), 15873 (NSD)
No
University Hospital of North Norway
University Hospital of North Norway
  • Finnmark Hospital Trust, Norway
  • The Royal Norwegian Ministry of Health
  • Norwegian Foundation for Health and Rehabilitation
  • Norwegian Directorate of Health
Study Chair: Trond Flægstad, Professor UNorth Norway
University Hospital of North Norway
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP