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Completed

NCT Number: NCT02290171

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

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.

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Key information

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bergen, Bergen, Hordaland, Norway

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activity groups

Behavioral

Children attend to activity groups weekly during the intervention periode.

Group based dietary counselling

Behavioral

Parents attend to four sessions of group based dietary counselling

Individual counselling

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Eivind Meland

Other

Collaborators

  • University of Agder

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 13, 2014
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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