Promoting Health in Healthy Living Centres - a Clinical Study Among Children
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|ClinicalTrials.gov Identifier: NCT02290171|
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : October 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Health Behavior||Behavioral: Activity groups Behavioral: Group based dietary counselling Behavioral: Individual counselling||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||152 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Promoting Health in Healthy Living Centres - a Clinical Study Among Famililies With Overweight Children|
|Actual Study Start Date :||August 2014|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Active Comparator: Intervention group
The intervention groups start the intervention 6 months ahead of the control group.
Behavioral: Activity groups
Children attend to activity groups weekly during the intervention periode.
Behavioral: Group based dietary counselling
Parents attend to four sessions of group based dietary counselling
Behavioral: Individual counselling
Parents attend to individual counselling focusing on parental skills and family structure
No Intervention: Delayed intervention group
The control groups will start intervention with 6 months delay
- Iso-BMI [ Time Frame: 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
- Physical activity level [ Time Frame: 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.
- Dietary habits [ Time Frame: 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.
- Self-perceived health [ Time Frame: 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.
- Autonomous regulation and perceived autonomy support [ Time Frame: 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.
- Motor skills [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290171
|University of Bergen|
|Bergen, Hordaland, Norway, 5018|
|University of Agder|
|Kristiansand, Vest-Agder, Norway, 4604|
|Principal Investigator:||Eivind Meland, MD, PhD||Dept of Glob Publ Health and Primary Care, University of Bergen|