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Completed

NCT Number: NCT00872807

The Activity School in Finnmark for Overweight Children

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.

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Key information

Conditions

Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Childrens departement Finnmark Hospital, Norway

Hammerfest, 9600, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifestyle counseling in groups

Behavioral

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.

Individual intervention

Behavioral

Conventional lifestyle counseling individually by single health professionals, both in hospital and in municipality.

Primary outcomes

  1. Change in Body Mass Index compared to baseline

    Time frame: 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 outcomes

  1. Change in Systolic Blood Pressure compared to baseline

    Time frame: 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.

  2. Change in Body fat compared to baseline

    Time frame: 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.

  3. Change in activity level / Counts per min compared to baseline

    Time frame: 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.

  4. Change in Waist circumference compared to baseline

    Time frame: 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.

  5. Change in Homa Score / HOMA IR compared to baseline

    Time frame: 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.

  6. Change in triceps skinfold compared to baseline

    Time frame: 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.

  7. Change in self-concept compared to baseline

    Time frame: 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.

  8. Change in psychiatric health compared to baseline

    Time frame: 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.

  9. Change in fitness from baseline

    Time frame: 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.

  10. Change in quality of life compared to baseline

    Time frame: 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.

Other outcomes

  1. Change in lipid levels compared to baseline

    Time frame: 3 years

    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

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • Finnmark Hospital Trust
  • Norwegian Directorate of Health
  • Norwegian Foundation for Health and Rehabilitation
  • The Royal Norwegian Ministry of Health

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Mar 31, 2009
Registry last updated
Dec 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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