NCT02720302

Treatment of Overweight in Children on Distance

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Skane University Hospital · Academic / Other
• Sex: All
• Age: 9 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Overweight

Interventions

Type	Name	Description
BEHAVIORAL	SOFT	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.
BEHAVIORAL	TeleSOFT	The therapists communicate with the overweight child and his/her family by the SOFT method on distance by use of video.

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-12-20
• Completion: 2025-01-31
• First posted: 2016-03-25
• Last updated: 2024-04-17

Locations

1 site across 1 country: Sweden