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

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.

Study Overview

• Status: Completed
• Conditions: Health Behavior
• Intervention / Treatment: Behavioral: Activity groups; Behavioral: Group based dietary counselling; Behavioral: Individual counselling

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).

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Hordaland
    • Bergen, Hordaland, Norway, 5018
      • University of Bergen
  • Vest-Agder
    • Kristiansand, Vest-Agder, Norway, 4604
      • University of Agder

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; The intervention groups start the intervention 6 months ahead of the control group.	Behavioral: Activity groups; Children attend to activity groups weekly during the intervention periode.; Behavioral: Group based dietary counselling; Parents attend to four sessions of group based dietary counselling; Behavioral: Individual counselling; Parents attend to individual counselling focusing on parental skills and family structure
No Intervention: Delayed intervention group; The control groups will start intervention with 6 months delay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Eivind Meland
• Collaborators: University of Agder
• Investigators: Principal Investigator: Eivind Meland, MD, PhD, Dept of Glob Publ Health and Primary Care, University of Bergen

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: October 26, 2014
• First Submitted That Met QC Criteria: November 8, 2014
• First Posted (Estimate): November 13, 2014

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: NCT02290171

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No