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
  Purpose

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.


Condition Intervention
Obesity
Overweight
Behavioral: Lifestyle counseling in groups
Behavioral: Individual intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Activity School in Finnmark for Overweight and Obese Children and Their Families

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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


Enrollment: 97
Study Start Date: April 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872807

Locations
Norway
Childrens departement Finnmark Hospital, Norway
Hammerfest, Norway, 9600
Sponsors and Collaborators
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
Investigators
Study Chair: Trond Flægstad, Professor UNorth Norway
  More Information

No publications provided by University Hospital of North Norway

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00872807     History of Changes
Other Study ID Numbers: 2007/5.2006.3473 (REK), 15873 (NSD)
Study First Received: March 30, 2009
Last Updated: December 4, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Keywords provided by University Hospital of North Norway:
childhood
therapy
life style
motor activity
obesity
overweight
body mass index
treatment

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014