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Clinical Trials/NCT02290171
NCT02290171
Completed
N/A

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

Eivind Meland2 sites in 1 country152 target enrollmentAugust 2014
ConditionsHealth Behavior

Overview

Phase
N/A
Intervention
Not specified
Conditions
Health Behavior
Sponsor
Eivind Meland
Enrollment
152
Locations
2
Primary Endpoint
Iso-BMI
Status
Completed
Last Updated
6 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
December 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Eivind Meland
Responsible Party
Sponsor Investigator
Principal Investigator

Eivind Meland

Professor

University of Bergen

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Physical activity level(6 months, 1 and 2 years)
  • Self-perceived health(6 months, 1 and 2 years)
  • Dietary habits(6 months, 1 and 2 years)

Study Sites (2)

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