Impact of Comprehensive Intervention on the Cardiometabolic Risk in Children With Central Obesity (IGENOI)Obesity
NCT ID: NCT03147261
Last Updated: 2024-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2015-12-31
2024-05-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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lifestyle intervention
Intensive follow up in lifestyle factors with a reduced calorie DM , physical activity and behavioural therapy.
Lifestyle intervention
Intensive changes in lifestyle with a reduced calorie mediterranean diet, physical activity and behavioral therapy
No intervention
Healthy diet recommendations following the usual pediatric advice
No interventions assigned to this group
Interventions
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Lifestyle intervention
Intensive changes in lifestyle with a reduced calorie mediterranean diet, physical activity and behavioral therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
7 Years
16 Years
ALL
No
Sponsors
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University of Navarra
OTHER
Clinica Universidad de Navarra, Universidad de Navarra
OTHER
Responsible Party
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Principal Investigators
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Amelia Marti, PhD
Role: STUDY_DIRECTOR
University of Navarra
Locations
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UNavarre
Pamplona, Navarre, Spain
Countries
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References
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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.
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.
Other Identifiers
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UNavarre
Identifier Type: -
Identifier Source: org_study_id
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