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Trial record 2 of 6081 for:    healthy living centres

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

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ClinicalTrials.gov Identifier: NCT02290171
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
University of Agder
Information provided by (Responsible Party):
Eivind Meland, University of Bergen

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.

Condition or disease Intervention/treatment Phase
Health Behavior Behavioral: Activity groups Behavioral: Group based dietary counselling Behavioral: Individual counselling Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Promoting Health in Healthy Living Centres - a Clinical Study Among Famililies With Overweight Children
Actual Study Start Date : August 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290171


Locations
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Norway
University of Bergen
Bergen, Hordaland, Norway, 5018
University of Agder
Kristiansand, Vest-Agder, Norway, 4604
Sponsors and Collaborators
Eivind Meland
University of Agder
Investigators
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Principal Investigator: Eivind Meland, MD, PhD Dept of Glob Publ Health and Primary Care, University of Bergen
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Responsible Party: Eivind Meland, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT02290171    
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019