NCT03749291Completed
Motivational Intervention on the Gut Microbiota of Obese Children
Effect of a Motivational Intervention on the Gut Microbiota and the Components of the Metabolic Syndrome in a Population of Obese Children
Source: ClinicalTrials.gov · Last updated 2 Dec 2024
Brief summary (registry, in English)
Animal models and studies on small samples of obese adults have shown that gut microbial diversity and certain types of bacteria could predict the efficacy of the dietetic treatment to improve body mass index (BMI) and the components of metabolic syndrome (MetS). Gut microbiota could distinguish the obese with metabolic syndrome patient than that metabolically healthy. Dietetic therapy could induce changes in the microbiota that could lead to improvement of BMI and the components of the MetS. The aim of MICROBEkids is to test whether the motivational intervention a motivational intervention (OBEMAT2.0) (PI15/00970) is more effective than the conventional intervention to increase the gut microbial diversity and, as a consequence, to improve BMI and MetS components. The role of gut microbiota (through modulation of the short chain fatty acids) will be analyzed as cardiovascular risk factor and as predictor of treatment success. These objectives will be achieved through a clustered clinical trial design with an intervention group that will receive a motivational therapy compared to a control group that will receive a conventional intervention, both during 12 months. The study sample are 319 children (n= 167 in the intervention group) that were enrolled in the clinical trial OBEMAT2.0 (PI15/00970), have had a comprehensive clinical assessment before the intervention (ages 8 to 14) and after 12 months (+3) of therapy (ages 9 to 15) and furthermore have participated in a biological samples collection for the investigation on childhood obesity (COLOBEPED, reference C.0004585).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 219 (actual)
- First submitted
- 8 Oct 2018
- Start date
- 1 Jan 2019
- Primary completion date
- 31 Dec 2021
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Diseases
- Obesity
- NCT number
- NCT03749291
What you commit to
- Study type: Interventional
- Participants enrolled: 219
- From 1 Jan 2019 to the primary completion date, 31 Dec 2021
- 3 sites 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.
Other illness
- Children with eating disorders
- Presence of endocrine disorders (GH disorder, hypothyroidism, Cushing's disease, early puberty or other)
Other
- Families not available to attend to scheduled visits
- Simultaneous participation in another clinical trial
- Lack of command of local languages
Who the study is looking for
- Age range between 8 and \<14 years at enrolment (so that, children would end the treatment at maximum age of 15 years
- BMI \> 97th percentile of Hernandez references from 1988 (Hernández et al., 1988) as indicated by the Guidelines for Clinical Practice of the Spanish Health System (Grupo de trabajo de la Guía de Práctica Clínica sobre la Prevención y el Tratamiento de la Obesidad Infantojuvenil. Ministerio de Ciencia e Innovación \[Spanish Ministry of Sciencee and Innovation\], 2009) for the diagnose of the childhood obesity.
Age in the registry: 8 years to 15 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Iispv- Hospital Sant Joan de Reus Coordinator of this site? Confirm its status | Reus | Spain | Unknown status |
| Faculty of Medicine, C/ Sant Llorenç 21 Coordinator of this site? Confirm its status | Reus | Spain | Unknown status |
| Hospital de Tarragona Joan XXIII Coordinator of this site? Confirm its status | Tarragona | Spain | Unknown status |
Related publications
- Children's gut microbiota predicts the efficacy of obesity treatment.Gut Microbes · 2026 · PMID 41711285
This page is information, not medical advice. Discuss any trial with your doctor.