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The Activity School in Finnmark for Overweight Children

11 december 2014 bijgewerkt door: University Hospital of North Norway

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Studietype

Ingrijpend

Inschrijving (Werkelijk)

97

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Noorwegen
      • Hammerfest, Noorwegen, 9600
        • Childrens departement Finnmark Hospital, Norway

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

6 jaar tot 12 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.

Gedragsmatig: Individual intervention
Conventional lifestyle counseling individually by single health professionals, both in hospital and in municipality.
Actieve vergelijker: Individual intervention
Lifestyle counseling for each separate family practiced by single health professionals both in hospital and municipality. A more conventional model.
Gedragsmatig: Individual intervention
Conventional lifestyle counseling individually by single health professionals, both in hospital and in municipality.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Body Mass Index compared to baseline
Tijdsspanne: 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.
3 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Systolic Blood Pressure compared to baseline
Tijdsspanne: 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.
3 years
Change in Body fat compared to baseline
Tijdsspanne: 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 years
Change in activity level / Counts per min compared to baseline
Tijdsspanne: 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.
3 years
Change in Waist circumference compared to baseline
Tijdsspanne: 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.
3 years
Change in Homa Score / HOMA IR compared to baseline
Tijdsspanne: 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.
3 years
Change in triceps skinfold compared to baseline
Tijdsspanne: 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.
3 years
Change in self-concept compared to baseline
Tijdsspanne: 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.
3 years
Change in psychiatric health compared to baseline
Tijdsspanne: 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.
3 years
Change in fitness from baseline
Tijdsspanne: 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.
3 years
Change in quality of life compared to baseline
Tijdsspanne: 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.
3 years

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in lipid levels compared to baseline
Tijdsspanne: 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
3 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital of North Norway

Medewerkers

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

Onderzoekers

  • Studie stoel: Trond Flægstad, Professor, UNorth Norway

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2009

Primaire voltooiing (Werkelijk)

1 december 2012

Studie voltooiing (Werkelijk)

1 december 2013

Studieregistratiedata

Eerst ingediend

30 maart 2009

Eerst ingediend dat voldeed aan de QC-criteria

30 maart 2009

Eerst geplaatst (Schatting)

31 maart 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

12 december 2014

Laatste update ingediend die voldeed aan QC-criteria

11 december 2014

Laatst geverifieerd

1 december 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2007/5.2006.3473 (REK)
  • 15873 (NSD) (Andere identificatie: Norwegian social science data services)

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