Family Based Intervention in Childhood obesitY

Study Overview
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Brief Summary
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The study compares the effect on BMI of two different treatment options for obesity in childhood. Families with at least one obese child and parent are invited to join the project. The hypothesis is that family camp gives an additional reduction in BMI compared to a less intensive family lifestyle school.

Detailed Description
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Participants are randomised to two intervention groups: A): Two weeks family camp and two years follow-up as a cooperation with primary health care, private rehabilitation center and specialist health care. B): Four days lifestyle school with two years follow-up as a cooperation with primary health care and specialist health care

Official Title
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Randomised Controlled Clinical Trial Comparing Two Family Interventions to Treat Obesity in Children Between 7 and 12 Years.

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Parent Management Training - Oregon (PMTO)
* Behavioral: Motivational interviewing
* Behavioral: Dynamic group therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 7 to 12 years BMI > iso-BMI 30 (Coles index) Exclusion Criteria: syndromatic obesity obesity related to diseases local community not involved child has present follow-up because of obesity in secondary health care parent has present/planned follow-up because of obesity in secondary health care

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A - family camp<br>Obese families participate in a two week camp with two years follow-up. | Behavioral: Parent Management Training - Oregon (PMTO)<br>* Method to help parents and caregivers manage the behavior of the children they are responsible for.<br>Behavioral: Motivational interviewing<br>* Communication method to facilitate behavioral change and empower the parents.<br>Behavioral: Dynamic group therapy<br>* Focuses on individual experiences within families and/or parents/children, and that the participants are their own experts.<br>|
| Other: Group B - family lifestyle school<br>Families participate in a four day practical course about lifestyle. | Behavioral: Motivational interviewing<br>* Communication method to facilitate behavioral change and empower the parents.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI-SDS | Primary Outcome Measure is body mass index-standard deviation score. Reduced values from baseline to endpoint means reduced overweight. | After 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Questionnaire for children and parent | After 2 years | 
| Physical fitness | Six minutes walk test for children and parents. | After 2 years | 
| Behaviour | Evaluating effect of intervention on risk for psyciatric disorders. | After 2 years | 
| Blood samples | Improvement in spesific blood tests with relevance to metabolic syndrome after 2 years intervention? Blood is biobanked at baseline and after 2 years. | After 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Child, Parent, Family