Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/02/2015
Date assigned
12/02/2015
Last edited
12/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
segundomoran@hotmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Segundo Moran

ORCID ID

http://orcid.org/0000-0001-6833-2392

Contact details

Pediatric Hospital of the National Medical Center XXI Century
Avenida Cuauhtémoc 330
Colonia Doctores
Mexico
06725
Mexico
+525556276900 (extension 22363)
segundomoran@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2006/3603/022

Study information

Scientific title

Effect of lifestyle intervention in children with obesity and non-alcoholic fatty liver disease

Acronym

Study hypothesis

The lifestyle of children with obesity and non-alcoholic fatty liver disease can improve with a lifestyle intervention programme

Ethics approval

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

Study design

Interventional single-centre study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Non-alcoholic liver dsease

Intervention

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.

Intervention type

Behavioural

Phase

Drug names

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

02/01/2006

Overall trial end date

14/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 6–16 years old
2. Obesity
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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

46 patients

Participant exclusion criteria

1. History of medication misuse
2. Alcohol misuse
3. Hepatitis C
4. Hepatitis B
5. Wilson's disease

Recruitment start date

01/10/2008

Recruitment end date

17/12/2010

Locations

Countries of recruitment

Mexico

Trial participating centre

Pediatric Hospital of the National Medical Center XXI Century
Avenida Cuauhtémoc 330 Colonia Doctores
Mexico
06725
Mexico

Sponsor information

Organisation

Fondo para el Fomento de la Investigación en Salud

Sponsor details

Mexican Institute of Social Securite
Avenida Cuauhtémoc 330
Colonia Doctores
Mexico
06725
Mexico

Sponsor type

Research council

Website

Funders

Funder type

Government

Funder name

Consejo Nacional de Ciencia y Tecnología (Mexico)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publish the results in a journal with an impact factor

Intention to publish date

31/12/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes