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

NCT03147261 | Completed

• 1 other identifier: UNavarre
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Outcome Measures

Primary Outcomes (1)

• changes in the HOMA index

  changes will be assessed in the HOMA index

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

Secondary Outcomes (1)

• genetic and epigenetic markers will be evaluated

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

Study Arms (2)

lifestyle intervention

EXPERIMENTAL

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

Other: Lifestyle intervention

No intervention

NO INTERVENTION

Healthy diet recommendations following the usual pediatric advice

Interventions

Lifestyle intervention OTHER

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

Also known as: No intervention

lifestyle intervention

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• University of Navarra: collaborator

Study Sites (1)

UNavarre

Pamplona, Navarre, 31008, Spain

Location

Related Publications (2)

• 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.

  PMID: 32007334 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.

  PMID: 30947686 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Amelia Marti, PhD

  University of Navarra

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 10, 2017
• Study Start: December 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: May 7, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)