An interventional study of Lifestyle intervention in Pediatric Obesity, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Completed at 1 site in Spain. Open to participants aged 7 Years to 16 Years. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Not applicable, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 120 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Clinica Universidad de Navarra, Universidad de Navarra is the lead sponsor of 158 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
Intensive follow up in lifestyle factors with a reduced calorie DM , physical activity and behavioural therapy.
Other: Lifestyle intervention
Healthy diet recommendations following the usual pediatric advice
Intensive changes in lifestyle with a reduced calorie mediterranean diet, physical activity and behavioral therapy
Also known as: No intervention
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
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
Plan to share: No
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Clinica Universidad de Navarra, Universidad de Navarra