Lifestyle programme in obese children with non-alcoholic fatty liver disease

ISRCTN	ISRCTN95490262
DOI	https://doi.org/10.1186/ISRCTN95490262
Secondary identifying numbers	2006/3603/022

Submission date: 05/02/2015
Registration date: 12/02/2015
Last edited: 09/08/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Segundo Moran
Scientific

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

ORCID ID	0000-0001-6833-2392
Phone	+525556276900 (extension 22363)
Email	segundomoran@hotmail.com

Study information

Study design	Interventional single-centre study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Effect of lifestyle intervention in children with obesity and non-alcoholic fatty liver disease
Study objectives	The lifestyle of children with obesity and non-alcoholic fatty liver disease can improve with a lifestyle intervention programme
Ethics approval(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	02/01/2006
Completion date	14/12/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	16 Years
Sex	Both
Target number of participants	46 patients
Key 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
Key exclusion criteria	1. History of medication misuse 2. Alcohol misuse 3. Hepatitis C 4. Hepatitis B 5. Wilson's disease
Date of first enrolment	01/10/2008
Date of final enrolment	17/12/2010

Locations

Countries of recruitment

Mexico

Study participating centre

Pediatric Hospital of the National Medical Center XXI Century

Avenida Cuauhtémoc 330
Colonia Doctores
Mexico
06725
Mexico

Sponsor information

Fondo para el Fomento de la Investigación en Salud
Research council

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

Funders

Funder type

Government

Consejo Nacional de Ciencia y Tecnología (Mexico)

No information available

Results and Publications

Intention to publish date	31/12/2015
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Publish the results in a journal with an impact factor
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2017		Yes	No

Editorial Notes

09/08/2018: Publication reference added