Clinical trial NCT02290171: Promoting Health in Healthy Living Centres - a Clinical Study Among Children
Official title: Promoting Health in Healthy Living Centres - a Clinical Study Among Famililies With Overweight Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: University of Agder
First posted: 2014-11-13
Enrollment: 152
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Iso-BMI
timeFrame: Change at 6 months, 1 year, 2 years
Secondary outcomes:
measure: Physical activity level
timeFrame: 6 months, 1 and 2 years
measure: Dietary habits
timeFrame: 6 months, 1 and 2 years
measure: Self-perceived health
timeFrame: 6 months, 1 and 2 years
Other outcomes:
measure: Autonomous regulation and perceived autonomy support
timeFrame: 6 months, 1 and 2 years
measure: Motor skills
timeFrame: 6 months, 1 and 2 years
Locations:
city: Bergen
country: Norway
facility: University of Bergen
state: Hordaland
city: Kristiansand
country: Norway
facility: University of Agder
state: Vest-Agder
Study officials:
affiliation: Dept of Glob Publ Health and Primary Care, University of Bergen
name: Eivind Meland, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: