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Completed

NCT Number: NCT03147261

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

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.

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Key information

Conditions

Pediatric Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNavarre

Pamplona, Navarre, 31008, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

  • Pre-Diabetes
  • Presence of other diseases
  • Pharmacotherapy
  • Monitoring special diets
  • Food intolerance
  • Regular alcohol consumption
  • Drug
  • Psychiatric illness or eating disorder
  • People without telephone or Internet access

Treatment and study plan

lifestyle intervention

Other

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

Other names: No intervention

Primary outcomes

  1. changes in the HOMA index

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

    changes will be assessed in the HOMA index

Secondary outcomes

  1. genetic and epigenetic markers will be evaluated

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

    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

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Collaborators

  • University of Navarra

Registry information

Official study title

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

Acronym: IGENOI

Important dates

Study start
2015
Primary completion
2018
Study completion
2024
First posted
May 10, 2017
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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