- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Hordaland
-
Bergen, Hordaland, Norvège, 5018
- University of Bergen
-
-
Vest-Agder
-
Kristiansand, Vest-Agder, Norvège, 4604
- University of Agder
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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
|
|
Aucune intervention: Delayed intervention group
The control groups will start intervention with 6 months delay
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Iso-BMI
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Physical activity level
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Autonomous regulation and perceived autonomy support
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Eivind Meland, MD, PhD, Dept of Glob Publ Health and Primary Care, University of Bergen
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- NCT02290171
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .