Impact of Comprehensive Intervention on the Cardiometabolic Risk in Children With Central Obesity (IGENOI)Obesity

Pediatric Obesity Clinical Trial

— IGENOI  

Official title:

Impacto de Una intervención Integral Sobre el Riesgo cardiometabólico en niños Con Obesidad Central: Estudio de Marcadores genéticos y epigenéticos

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147261
• Other study ID #: UNavarre
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: May 7, 2024

Study information

• Verified date: May 2024
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Central obesity, present in the metabolic syndrome (MS), is associated with increased risk of insulin resistance (RI). The aim of the project is to evaluate the protective effect of comprehensive intervention (Mediterranean diet + physical activity) in the development of RI in children with central obesity based on genetic and epigenetic markers.

Description:

Objectives: 1) Apply a comprehensive therapeutic nutrition intervention program for monitoring the Mediterranean Diet (DM) slightly hypocaloric along with increased physical activity in children with central obesity 7-16 years). 2) Measure the effectiveness of this program by assessing changes in body composition, lifestyle and biological and molecular parameters (genetic and epigenetic).

Methodology: test randomized, longitudinal, controlled, two-year intervention field comparing a sample of 120 subjects from 7 to 16 years with central obesity, the effect of two interventions: a) intensive on lifestyle with a reduced calorie DM , physical activity and behavioral therapy, b) non-intensive with healthy diet recommendations following the usual pediatric advice. At 2, 6, 12 and 24 months after follow up changes will be assessed: a) the HOMA index, body fat, and the cardiovascular risk factors, b) diet, sleep patterns, physical exercise using questionnaires and accelerometers (intervention group), and c) the quality of life. genetic and epigenetic markers will be evaluated by genotyping SNPs genes related to RI; and the analysis of: a) DNA methylation in genes related to insulin resistance, b) expression of microRNAs and target genes related to insulin resistance and c) measure the length of telomeres. The therapeutic program will consist of individual sessions and group workshops for the patient and the family.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 7, 2024
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent by the child, parent or guardian. 3. waist circumference above the 90th percentile 4. Motivation and willingness to be assigned to either group, and do their utmost to follow protocol assigned.

5. Possibility of involvement in days of intensive phase (week 0, 1, 2, 3, 4, 5, 6, 7 and 8) and once a month until 6 months later at 4 months and every 6 months during the second year.

Exclusion Criteria:

1. Pre-Diabetes

2. Presence of other diseases

3. Pharmacotherapy

4. Monitoring special diets

5. Food intolerance

6. Regular alcohol consumption

7. Drug

8. Psychiatric illness or eating disorder

9. People without telephone or Internet access

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Other:
• Lifestyle intervention
Intensive changes in lifestyle with a reduced calorie mediterranean diet, physical activity and behavioral therapy

Locations

Country	Name	City	State
Spain	UNavarre	Pamplona	Navarra

Sponsors (2)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	University of Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in the HOMA index	changes will be assessed in the HOMA index	At 2, 6, 12 and 24 months after follow up
Secondary	genetic and epigenetic markers will be evaluated	genetic and epigenetic markers will be evaluated by genotyping SNPs genes related to RI; and the analysis of: a) DNA methylation in genes related to insulin resistance, b) expression of microRNAs and target genes related to insulin resistance and c) measure the length of telomeres	At 2, 6, 12 and 24 months after follow up