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

Clinica Universidad de Navarra, Universidad de Navarra120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Pediatric Obesity

Interventions

Lifestyle interventionOTHER

Intensive changes in lifestyle with a reduced calorie mediterranean diet, physical activity and behavioral therapy

Eligibility

Sex: ALLMin age: 7 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

UNavarre

Pamplona, Navarre, Spain

Outcomes

Primary Outcomes

changes in the HOMA index

changes will be assessed in the HOMA index

Time frame: At 2, 6, 12 and 24 months after follow up

Secondary Outcomes

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

Time frame: At 2, 6, 12 and 24 months after follow up

Data from ClinicalTrials.gov

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