CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 115 enrolled
Drug / intervention
Multidisciplinary intervention programother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02258126
NCT02258126N/ACompleted

The Effect of Exercise on Hepatic Fat in Overweight Children; the EFIGRO Study

University of the Basque Country (UPV/EHU)·interventional·Posted Oct 7, 2014·Updated Apr 1, 2019

In Brief

A clinical study evaluating Multidisciplinary intervention program for Non-alcoholic Fatty Liver Disease and 2 related conditions. Completed, enrolled 115 participants across 1 site.

Detailed Summary

The objective of the present study is to evaluate the effect of 6 months exercise intervention program on hepatic fat fraction in overweight children. Methodology: A total of 160 children, 9-11 years old, will be randomly assigned to control (N=80) or intervention (N=80) groups. Training sessions will include 90 minutes of exercise, comprising warm-up and skill development. The control group will attend a healthy lifestyle education program (2 days/month) and the intervention group an exercise (3 days/week) and healthy lifestyle education (2 days/month) combined program. Before and after the intervention (6 months) hepatic fat fraction, body composition, , and cardiometabolic risk factors will be measured. Furthermore, dietary habits and physical activity, blood pressure and pubertal development will be evaluated before and after the intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 7, 2014
Enrollment StartNov 1, 2014
Primary CompletionNov 1, 2017
Study CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 11.7 years ago

Interventions

Multidisciplinary intervention programother

Exercise group: The intervention program includes an education program promoting healthy dietary habits and physical activity (nutritionist), supportive therapy and behavioral advice for the family to improve nutrition and physical activity (psychologist) (2 times/month, for children and parents) and supervised exercise (3 times/week, 90 mins) program for 6 months.