Plain English Summary
Background and study aims
There is evidence that family dietary education programmes are effective in children with obesity, but there is little evidence of this in children with non-alcoholic fatty liver disease (a build-up of fat in the liver cells). The aim in this study is to assess the effect of a nutritional counselling programme on hepatic abnormalities associated with non-alcoholic fatty liver disease in obese children.
Who can participate?
Children who are obese and have non-alcoholic fatty liver disease
What does the study involve?
Patients will have a clinical assessment and liver function tests at baseline and after 4 months of intervention. They will attend nutrition counselling sessions with their parents or guardians every 15 days.
What are the possible benefits and risks of participating?
The possible benefits are body-mass index reduction and improvement in the primary alterations in liver function associated with non-alcoholic fatty liver disease in obesity. Risks not provided at time of registration.
Where is the study run from?
Pediatric Hospital of the National Medical Center XXI Century (Mexico)
When is the study starting and how long is it expected to run for?
From October 2008 to December 2012
Who is funding the study?
National Council of Science and Technology (Mexico)
Who is the main contact?
Dr Segundo Moran
Effect of lifestyle intervention in children with obesity and non-alcoholic fatty liver disease
The lifestyle of children with obesity and non-alcoholic fatty liver disease can improve with a lifestyle intervention programme
Ethics board of the Pediatric Hospital at the National Medical Center Century XXI of the Mexican Institute of Social Securite (Mexico), 02/05/2006, 37B5032500/232/06
Interventional single-centre study
Primary study design
Secondary study design
Non randomised study
Patient information sheet
Non-alcoholic liver dsease
From the start of the study and every 15 days thereafter during 4 months, both children and their parents in small groups had one-hour sessions conducted by a dietitian and a medical doctor. These sessions provided educational material about the importance of adequate food intake, with emphasis on lowering the amount of refined sugar and sugary sodas, reducing the amount of carbohydrates and fat consumed every day, and increasing the amount of fibre.
Primary outcome measures
At baseline and after 4 months of intervention:
1. Clinical evaluation
2. Liver function tests
Secondary outcome measures
Lipid profile at baseline and after 4 months of intervention
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Age 6–16 years old
3. Non-alcoholic fatty liver disease (ultrasound findings of steatosis, alanine aminotransferase > 40 U/L and alanine aminotransferase to aspartate aminotransferase ratio > 1)
4. No other cause of liver disease
Target number of participants
Participant exclusion criteria
1. History of medication misuse
2. Alcohol misuse
3. Hepatitis C
4. Hepatitis B
5. Wilson's disease
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Pediatric Hospital of the National Medical Center XXI Century
Avenida Cuauhtémoc 330 Colonia Doctores
Consejo Nacional de Ciencia y Tecnología (Mexico)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Publish the results in a journal with an impact factor
Intention to publish date
Participant level data
Available on request
Results - basic reporting