- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02290171
Promoting Health in Healthy Living Centres - a Clinical Study Among Children
Promoting Health in Healthy Living Centres - a Clinical Study Among Famililies With Overweight Children
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The investigators intend to perform a controlled clinical trial on interventions on a systemic level.
The target group is overweight and obese children between 6 and 10 years old, their parents, community administrators and public health nurses. The overall aim is to evaluate if a familybased intervention, targeting overweight and obese children and their parents, has a long-term positive effect on weight development of the children. The alternative hypothesis to the zero hypothesis is that the children with overweight and obesity who participate with their parents, both at completion of the six months intervention and at long term follow up (2 years) will have reduced their BMI-for-age z-score (Iso-BMI). The behavioral models and educational strategies will be tailored (by age, gender etc.) and include both general information and practical learning sessions. The program will offer guided active play, defined as spontaneous gross locomotor movement in which children engage to amuse and to occupy themselves.
Parents will attend to workshops intending to increase knowledge and awareness of family structure, healthy eating habits and practical suggestions for implementing healthy behaviors into everyday life. Parents will be educated on how to use these strategies at home, to further support their children in improving their behaviors. This community based study is the support by the local leadership and collaboration with locally based sports clubs. The primary outcome variable, child BMI-for-age z-score will be measured at referral, inclusion, after 6 months, and at 1 and 2 years post intervention. Secondary outcome variables, measured at inclusion and at the end of intervention, are child activity pattern, screen viewing time, eating habits, sleeping patterns and body composition as well as parent BMI, body composition, exercise habits, perception of health, experience of parenthood and level of parental stress.
Physical activity level as well as sleep duration and -quality will be recorded using biaxial accellerometers. A validated food diary will be used. The participants will also be asked to complete a questionnaire including questions about screen viewing time, self-perceived healt, sleeping patterns (children) and perceived autonomy support and autonomous regulations (parents).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Hordaland
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Bergen, Hordaland, Noruega, 5018
- University of Bergen
-
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Vest-Agder
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Kristiansand, Vest-Agder, Noruega, 4604
- University of Agder
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Iso-BMI>25,
- able to participate in activity groups
Exclusion Criteria:
- Children being unable to participate in activity groups,
- parents not able to participate in group based and individual counseling
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Intervention group
The intervention groups start the intervention 6 months ahead of the control group.
|
Children attend to activity groups weekly during the intervention periode.
Parents attend to four sessions of group based dietary counselling
Parents attend to individual counselling focusing on parental skills and family structure
|
|
Sin intervención: Delayed intervention group
The control groups will start intervention with 6 months delay
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Iso-BMI
Periodo de tiempo: Change at 6 months, 1 year, 2 years
|
Measure change at 6 month controlled study, and at 1 and 2 years to measure long-term effects
|
Change at 6 months, 1 year, 2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Physical activity level
Periodo de tiempo: 6 months, 1 and 2 years
|
Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects.
We will use SenseWear bi-axial accelerometer to mesa sure physics activity.
|
6 months, 1 and 2 years
|
|
Dietary habits
Periodo de tiempo: 6 months, 1 and 2 years
|
Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects.
We will use a specially designed questionnaire to measure dietary habits.
|
6 months, 1 and 2 years
|
|
Self-perceived health
Periodo de tiempo: 6 months, 1 and 2 years
|
Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects.
We will use KidScreen 10 questionnaire to measure self-perceived health.
|
6 months, 1 and 2 years
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Autonomous regulation and perceived autonomy support
Periodo de tiempo: 6 months, 1 and 2 years
|
Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects.
We will use Treatment Self-regulation Questionnaire to measure autonomous regulation, and Healt Care Climate Questionnaire to measure autonomy support.
|
6 months, 1 and 2 years
|
|
Motor skills
Periodo de tiempo: 6 months, 1 and 2 years
|
Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects.
We will use Kôrper-koordinationstest fur Kinder to measure motor skills.
|
6 months, 1 and 2 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Eivind Meland, MD, PhD, Dept of Glob Publ Health and Primary Care, University of Bergen
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- NCT02290171
Información sobre medicamentos y dispositivos, documentos del estudio
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