Promoting Health in Healthy Living Centres - a Clinical Study Among Children
Condition: Health Behavior
Study type: Interventional

Summary: 
      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 and health
      of the children. The alternative hypothesis to the zero hypothesis is that the children with
      overweight and obesity who participate in a one-year intervention together with their
      parents, both at completion of the six months intervention and at long term follow up will
      have reduced their BMI-for-age z-score (Iso-BMI) and have adopted healthy habits. The
      behavioral models and educational strategies will be tailored (by age, gender etc.) and
      include both general information and practical learning sessions.
    

Detailed description: 
      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).
    

Intervention name(s): Activity groups; Group based dietary counselling; Individual counselling
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care