NCT03147261Completed
Impact of Comprehensive Intervention on the Cardiometabolic Risk in Children With Central Obesity (IGENOI)Obesity
Impacto de Una intervención Integral Sobre el Riesgo cardiometabólico en niños Con Obesidad Central: Estudio de Marcadores genéticos y epigenéticos
Source: ClinicalTrials.gov · Last updated 9 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 3 May 2017
- Start date
- 1 Dec 2015
- Primary completion date
- 28 Feb 2018
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Diseases
- Obesity
- NCT number
- NCT03147261
What you commit to
- Study type: Interventional
- Participants enrolled: 120
- From 1 Dec 2015 to the primary completion date, 28 Feb 2018
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Drug
Other illness
- Pre-Diabetes
- Presence of other diseases
- Psychiatric illness or eating disorder
Other
- Pharmacotherapy
- Monitoring special diets
- Food intolerance
- Regular alcohol consumption
- People without telephone or Internet access
Who the study is looking for
- 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.
Age in the registry: 7 years to 16 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UNavarre Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.