Group Sessions and Web-based Treatment Targeting Children With Obesity Age 5-12 Years and Their Families

Study Overview
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Brief Summary
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The aim of this study is to assess the efficacy of group sessions and a web-based program for children with obesity age 5-12 years and their parents. The intervention consist of a doctor's appointment, four group-based education sessions over four weeks, psychical activity on prescription and a 12-week web-based treatment program and will be offered to children aged 5-12 years with obesity (International Obesity Task Force-BMI >30), and their parents.

Detailed Description
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Obesity in children and adolescents worldwide has increased from 1 % in 1975 to about 6 % in 2016. Experts have estimated that the world will have more obese children and adolescents than underweight at the year 2022. Preventing and reversing excess weight gain in children is important since obesity often tracks into adulthood with adverse health consequences. Web-based interventions have been shown to be effective, to have a beneficial treatment outcome and have been proposed to have great potential to reach many children and improve cost effectiveness. This is a randomized controlled study with cross-over design. The intervention consist of a doctor's appointment, four group-based education sessions over four weeks, psychical activity on prescription and a 12-week web-based treatment program. The control group will have standard care treatment consisting of doctor's appointment and, in some cases, contact with dietician.

Official Title
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Group Sessions and Web-based Treatment Targeting Children With Obesity Age 5-12 Years and Their Families - a Randomized Controlled Trial of Children With Obesity in Northern Sweden

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: Usual care
* Behavioral: Web-COP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obesity according to International Obesity Task Force (IOTF) Be able to speak and write Swedish Have internet access in parents' home Exclusion Criteria: Obesity together with other severe disease including neuropsychiatric disorder

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>Usual care according to regular treatment routines at the clinic. | Behavioral: Usual care<br>* Visit doctor and nurse at the clinic.<br>Behavioral: Web-COP<br>* Usual care plus group sessions and a web-based treatment program for 12 weeks for the child and parents.<br>|
| Active Comparator: Web-COP<br>Usual care plus group sessions and a web-based treatment program | Behavioral: Usual care<br>* Visit doctor and nurse at the clinic.<br>Behavioral: Web-COP<br>* Usual care plus group sessions and a web-based treatment program for 12 weeks for the child and parents.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI-SDS | Controll vs intervention | At baseline, 2, 4 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Childhood obesity, BMI SDS