Treatment of Overweight in Children on Distance

Study Overview
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Brief Summary
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The present study is a public health project with the aim to treat overweight in children 9-11 years of age. After the first consultation the children are randomized to either continue the treatment at The Child Obesity Clinic, Child Department or to have the following 2-3 consultations on distance with Lync. Last visit for all children is on the Child Obesity Clinic after approximately 12 months. Follow up after at least 1 years will be performed.

Detailed Description
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This superiority study is a randomized trial with two independent treatment arms. The target for the enrollment is 50% in each of the two treatment groups. With 60 patients in each group, the study has 80% statistical power at 5% significance level to detect an average difference between the treatment groups in the intra-individual change in the BMI Z-score that is 0.51 x the standard deviation in the intra-individual change. Previous data from the investigators own group suggest that a reasonable estimate of the standard deviation in the intra-individual change in the BMI Z-score following intervention is 0.42. Thus, the study has 80% statistical power at 5% significance level to detect a difference in the intra-individual change in the BMI Z-score that is 0.51 x 0.42 = 0.21 on average. The study will with the present funding end its follow up in June 2017.

Official Title
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Treatment of Overweight in Children on Distance. A Comparison Between Consultations on the Hospital With Video-Consultations on Distance

Conditions
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Overweight

Intervention / Treatment
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* Behavioral: SOFT
* Behavioral: TeleSOFT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Children with overweight and not obese according to the definitions developed by Cole et al (4). It implies that we include children with the following age specific BMI Inclusion criteria 9 years = AGE < 9 years, 6 months AND 19,0< BMI<23,0 9 years, 6 months => AGE < 10 Years AND 19,5 <BMI<23,5 10 years = AGE < 10 years, 6 months AND 20,0<BMI<24,0 10 years, 6 months=>AGE< 11 years AND 20,5<BMI<24,5 11 years = AGE < 11 years, 6 months AND 21,0<BMI<25,5 11 years, 6 months =>AGE<12 years AND 21,5<BMI<25,5 Exclusion Criteria: Children and his/her parents not able to communicate in Swedish. Children with monogenic obesity Present less than 80% at school in the latest school year. No foster care for the child or his/her brothers or sisters

Ages Eligible for Study
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Minimum Age: 9 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOFT<br>All Children have their first and their last consultation at The Child Obesity Unit. The investigators use Standardized Obesity Family Therapy SOFT as described by Nowicka & Flodmark (1-3). The intervention use psychological techniques developed in systemic family therapy applied on advice regarding exercise and diet as well as behavioural Life style Changes. At each consultation with the overweight child and his/her biological parents there are two therapists present. | Behavioral: SOFT<br>* SOFT is based on systemic and solution-focused theories to change lifestyle and has shown positive effects on children with respect to the degree of obesity, physical fitness, self-esteem and family functioning.<br>|
| Experimental: TeleSOFT<br>The same method Lifestyle intervention SOFT is used. The only difference is that the communication in the second, third (and fourth) visit is made by use of video on distance. The investigators use Standardized Obesity Family Therapy SOFT as described by Nowicka & Flodmark (1-3). | Behavioral: TeleSOFT<br>* The therapists communicate with the overweight child and his/her family by the SOFT method on distance by use of video.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index standard deviation score (BMI Z-score) during treatment of overweight | Body weight measured by Tanita device | Change from Baseline in body weight at an average of 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fat percent measured by TANITA | TANITA measures fat percent via bioimpedance | Change from Baseline in fat percent at an average of 12 months | 
| Change in fat distribution measured by abdominal height (F-indicator) | F-indicator uses a laser beam to measure the abdominal height | Change from Baseline in fat distribution at an average of 12 months | 
| Change in fat distribution measured by waist circumference | Measured using a measurement tape | Change from Baseline in waist circumference at an average of 12 months | 
| Change in KIDSCREEN-index | Use a validated questionnaire | Change from Baseline in Kidscreen index at an average of 12 months | 
| Change in physical activity measured by Moves application to smartphone | Measured through an app on a smart phone. | Change from Baseline in physical activity at an average of 2, 4, 6, 8, 12 months | 
| Change child's metabolic health (Blood pressure) | Standardized laboratory tests will be performed | Change from Baseline in metabolic health at an average of 12 months | 
| Change child's metabolic health (LDL-cholesterol) | Standardized laboratory tests will be performed | Change from Baseline in metabolic health at an average of 12 months | 
| Change child's metabolic health (HDL-cholesterol) | Standardized laboratory tests will be performed | Change from Baseline in metabolic health at an average of 12 months | 
| Change child's metabolic health (triglycerides) | Standardized laboratory tests will be performed | Change from Baseline in metabolic health at an average of 12 months | 
| Change child's metabolic health (HbA1c) | Standardized laboratory tests will be performed | Change from Baseline in metabolic health at an average of 12 months | 
| Change child's metabolic health (F-blood glucose) | Standardized laboratory tests will be performed | Change from Baseline in metabolic health at an average of 12 months | 
| Change child's metabolic health (f-insulin) | Standardized laboratory tests will be performed | Change from Baseline in metabolic health at an average of 12 months | 
| Change child's metabolic health (ccK-18) | Standardized laboratory tests will be performed | Change from Baseline in metabolic health at an average of 12 months | 
| Change child's metabolic health (ALAT) | Standardized laboratory tests will be performed | Change from Baseline in metabolic health at an average of 12 months | 
| Change in dietary habits | Normal procedure at The Child Obesity Unit using a questionnaire | Change from Baseline in dietary habits at an average of 12 months | 
| Change in Outcome Rating Scale and Session Rating Scale | Measured psychological Health in general by four questions combined to a general score on a Visual analogue scale | Change from Baseline in Outcome Rating Scale at an average of 2, 4, 6, 8, 12 months | 
| Change in Session Rating Scale | Measured assessment of the consultation by visual analogue scale | Change from Baseline in Session Rating scale at an average of 2, 4, 6, 8, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight, Children, Treatment, Prevention, Lifestyle intervention