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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02290171
Enrollment
152
Registered
2014-11-13
Start date
2014-08-31
Completion date
2017-12-31
Last updated
2019-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior

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).

Interventions

BEHAVIORALActivity groups

Children attend to activity groups weekly during the intervention periode.

BEHAVIORALGroup based dietary counselling

Parents attend to four sessions of group based dietary counselling

Parents attend to individual counselling focusing on parental skills and family structure

Sponsors

University of Agder
CollaboratorOTHER
Eivind Meland
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Iso-BMIChange at 6 months, 1 year, 2 yearsMeasure change at 6 month controlled study, and at 1 and 2 years to measure long-term effects

Secondary

MeasureTime frameDescription
Physical activity level6 months, 1 and 2 yearsMeasure 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 habits6 months, 1 and 2 yearsMeasure 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 health6 months, 1 and 2 yearsMeasure 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.

Other

MeasureTime frameDescription
Autonomous regulation and perceived autonomy support6 months, 1 and 2 yearsMeasure 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 skills6 months, 1 and 2 yearsMeasure 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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026