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Pediatric ObesityIGENOINCT03147261

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

A study testing Lifestyle intervention in people with Pediatric Obesity, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 7 to 16 years
Conditions the study is for
Pediatric Obesity
What is being tested?
Lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSpain
Study dates
Dec 2015to 7 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Pre-Diabetes
  • Presence of other diseases
  • Pharmacotherapy
  • Monitoring special diets
  • Food intolerance
  • Regular alcohol consumption
Show all 9Show fewer
  • Drug
  • Psychiatric illness or eating disorder
  • People without telephone or Internet access

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • UNavarre

    Pamplona, Navarre, 31008

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Lifestyle intervention
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle interventionOther

    Also called No intervention

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

Study groups in NCT03147261
Study groupRoleWhat they receive
lifestyle interventionExperimentalIntensive follow up in lifestyle factors with a reduced calorie DM , physical activity and behavioural therapy.
Receives: Other: Lifestyle intervention
No interventionNo interventionHealthy diet recommendations following the usual pediatric advice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. changes in the HOMA index

    changes will be assessed in the HOMA index

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

Secondary outcomes (1)

  1. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2017
  2. Study startDec 2015
  3. Primary completionFeb 2018
  4. Study completion7 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03147261
Sponsor's protocol ID
UNavarre
Acronym
IGENOI
Status last verified
May 2024
First submitted
3 May 2017
Last updated
9 May 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41756638

  • 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.

    PubMed 32007334

  • 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.

    PubMed 30947686

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle intervention in people with Pediatric Obesity, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes in the HOMA index (time frame: At 2, 6, 12 and 24 months after follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03147261, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.

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