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| Name | Class |
|---|---|
| University of Navarra | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lifestyle intervention | Experimental | Intensive follow up in lifestyle factors with a reduced calorie DM , physical activity and behavioural therapy. |
|
| No intervention | No Intervention | Healthy diet recommendations following the usual pediatric advice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention | Other | Intensive changes in lifestyle with a reduced calorie mediterranean diet, physical activity and behavioral therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in the HOMA index | changes will be assessed in the HOMA index | At 2, 6, 12 and 24 months after follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Amelia Marti, PhD | University of Navarra | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNavarre | Pamplona | Navarre | 31008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41756638 | Derived | Ojeda-Rodriguez A, Lopez-Gil JF, Catalan-Lamban A, Azcona MC, Marti Del Moral A. Decreased ultra-processed food consumption as a mediator for lowering cardiovascular risk after a lifestyle program in pediatric obesity: a randomized clinical trial. Front Nutr. 2026 Feb 11;13:1753345. doi: 10.3389/fnut.2026.1753345. eCollection 2026. | |
| 32007334 |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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|
| Morell-Azanza L, Ojeda-Rodriguez A, Azcona-SanJulian MC, Zalba G, Marti A. Associations of telomere length with anthropometric and glucose changes after a lifestyle intervention in abdominal obese children. Nutr Metab Cardiovasc Dis. 2020 Apr 12;30(4):694-700. doi: 10.1016/j.numecd.2019.12.002. Epub 2019 Dec 10. |
| 30947686 | Derived | Morell-Azanza L, Ojeda-Rodriguez A, Ochotorena-Elicegui A, Martin-Calvo N, Chueca M, Marti A, Azcona-San Julian C. Changes in objectively measured physical activity after a multidisciplinary lifestyle intervention in children with abdominal obesity: a randomized control trial. BMC Pediatr. 2019 Apr 4;19(1):90. doi: 10.1186/s12887-019-1468-9. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |