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

Primary Purpose

Pediatric Obesity

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
Clinica Universidad de Navarra, Universidad de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity

Eligibility Criteria

7 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UNavarre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

lifestyle intervention

No intervention

Arm Description

Intensive follow up in lifestyle factors with a reduced calorie DM , physical activity and behavioural therapy.

Healthy diet recommendations following the usual pediatric advice

Outcomes

Primary Outcome Measures

changes in the HOMA index
changes will be assessed in the HOMA index

Secondary Outcome Measures

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

Full Information

First Posted
May 3, 2017
Last Updated
May 17, 2022
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
University of Navarra
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1. Study Identification

Unique Protocol Identification Number
NCT03147261
Brief Title
Impact of Comprehensive Intervention on the Cardiometabolic Risk in Children With Central Obesity (IGENOI)Obesity
Acronym
IGENOI
Official Title
Impacto de Una intervención Integral Sobre el Riesgo cardiometabólico en niños Con Obesidad Central: Estudio de Marcadores genéticos y epigenéticos
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2015 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
University of Navarra

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lifestyle intervention
Arm Type
Experimental
Arm Description
Intensive follow up in lifestyle factors with a reduced calorie DM , physical activity and behavioural therapy.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Healthy diet recommendations following the usual pediatric advice
Intervention Type
Other
Intervention Name(s)
Lifestyle intervention
Other Intervention Name(s)
No intervention
Intervention Description
Intensive changes in lifestyle with a reduced calorie mediterranean diet, physical activity and behavioral therapy
Primary Outcome Measure Information:
Title
changes in the HOMA index
Description
changes will be assessed in the HOMA index
Time Frame
At 2, 6, 12 and 24 months after follow up
Secondary Outcome Measure Information:
Title
genetic and epigenetic markers will be evaluated
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amelia Marti, PhD
Organizational Affiliation
University of Navarra
Official's Role
Study Director
Facility Information:
Facility Name
UNavarre
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32007334
Citation
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.
Results Reference
derived
PubMed Identifier
30947686
Citation
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.
Results Reference
derived

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

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