Promoting Health in Healthy Living Centres - a Clinical Study Among Children

Health Behavior Clinical Trial

Official title:

Promoting Health in Healthy Living Centres - a Clinical Study Among Famililies With Overweight Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02290171
• Other study ID #: NCT02290171
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 2017

Study information

• Verified date: October 2019
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior

Intervention

Behavioral:
• Activity groups
Children attend to activity groups weekly during the intervention periode.
• Group based dietary counselling
Parents attend to four sessions of group based dietary counselling
• Individual counselling
Parents attend to individual counselling focusing on parental skills and family structure

Locations

Country	Name	City	State
Norway	University of Bergen	Bergen	Hordaland
Norway	University of Agder	Kristiansand	Vest-Agder

Sponsors (2)

Lead Sponsor	Collaborator
Eivind Meland	University of Agder

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Autonomous regulation and perceived autonomy support	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
Other	Motor skills	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
Primary	Iso-BMI	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
Secondary	Physical activity level	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
Secondary	Dietary habits	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
Secondary	Self-perceived health	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