Treatment of Overweight in Children on Distance
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 120
Summary
- Conditions
- Overweight
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 9 years and 12 years
- Gender
- Both males and females
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 treatme...
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.
Tracking Information
- NCT #
- NCT02720302
- Collaborators
- Lund University
- Investigators
- Study Chair: Daniel Agardh, Professor Skane University Hospital
Get Well Soon