The Activity School in Finnmark for Overweight Children
11 de dezembro de 2014 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Randomized study design with two parallel groups.Active intervention in two years, last follow-up after 3 years.
Tipo de estudo
Intervencional
Inscrição (Real)
97
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
Hammerfest, Noruega, 9600
- Childrens departement Finnmark Hospital, Norway
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
6 anos a 12 anos (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
Conventional lifestyle counseling individually by single health professionals, both in hospital and in municipality.
|
|
Comparador Ativo: Individual intervention
Lifestyle counseling for each separate family practiced by single health professionals both in hospital and municipality.
A more conventional model.
|
Conventional lifestyle counseling individually by single health professionals, both in hospital and in municipality.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Body Mass Index compared to baseline
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Systolic Blood Pressure compared to baseline
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in lipid levels compared to baseline
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Trond Flægstad, Professor, UNorth Norway
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Kokkvoll A, Grimsgaard S, Odegaard R, Flaegstad T, Njolstad 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.
- Kokkvoll A, Grimsgaard S, Steinsbekk S, Flaegstad T, Njolstad I. Health in overweight children: 2-year follow-up of Finnmark Activity School--a randomised trial. Arch Dis Child. 2015 May;100(5):441-8. doi: 10.1136/archdischild-2014-307107. Epub 2014 Nov 20.
- Kokkvoll AS, Grimsgaard S, Flaegstad T, Andersen LB, Ball GDC, Wilsgaard T, Njolstad I. No additional long-term effect of group vs individual family intervention in the treatment of childhood obesity-A randomised trial. Acta Paediatr. 2020 Jan;109(1):183-192. doi: 10.1111/apa.14916. Epub 2019 Jul 30.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de abril de 2009
Conclusão Primária (Real)
1 de dezembro de 2012
Conclusão do estudo (Real)
1 de dezembro de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
30 de março de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de março de 2009
Primeira postagem (Estimativa)
31 de março de 2009
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
12 de dezembro de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de dezembro de 2014
Última verificação
1 de dezembro de 2012
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2007/5.2006.3473 (REK)
- 15873 (NSD) (Outro identificador: Norwegian social science data services)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .