Promoting Health in Healthy Living Centres - a Clinical Study Among Children
NCT ID: NCT02290171
Last Updated: 2019-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
152 participants
INTERVENTIONAL
2014-08-31
2017-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention group
The intervention groups start the intervention 6 months ahead of the control group.
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
Delayed intervention group
The control groups will start intervention with 6 months delay
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* able to participate in activity groups
Exclusion Criteria
* parents not able to participate in group based and individual counseling
6 Years
10 Years
ALL
Yes
Sponsors
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University of Agder
OTHER
Eivind Meland
OTHER
Responsible Party
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Eivind Meland
Professor
Principal Investigators
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Eivind Meland, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dept of Glob Publ Health and Primary Care, University of Bergen
Locations
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University of Bergen
Bergen, Hordaland, Norway
University of Agder
Kristiansand, Vest-Agder, Norway
Countries
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References
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Stea TH, Vettore MV, Ovrebo B, Abildsnes E. Changes in dietary habits and BMI z-score after a 6-month non-randomized cluster-controlled trial among 6-12 years old overweight and obese Norwegian children. Food Nutr Res. 2023 Dec 12;67. doi: 10.29219/fnr.v67.9617. eCollection 2023.
Other Identifiers
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NCT02290171
Identifier Type: -
Identifier Source: org_study_id
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