Status:
COMPLETED
Motivational Intervention on the Gut Microbiota of Obese Children
Lead Sponsor:
Institut Investigacio Sanitaria Pere Virgili
Collaborating Sponsors:
Hospital Universitari Joan XXIII de Tarragona.
Hospital Universitari Sant Joan de Reus
Conditions:
Microbial Colonization
Eligibility:
All Genders
8-15 years
Phase:
NA
Brief Summary
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 ma...
Detailed Description
The study will provide light to several hypothesis: \- The main hypothesis is that the dietetic intervention in obese children may improve the components of the metabolic syndrome by mediation (at le...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Children with eating disorders
- Families not available to attend to scheduled visits
- Simultaneous participation in another clinical trial
- Presence of endocrine disorders (GH disorder, hypothyroidism, Cushing's disease, early puberty or other)
- Lack of command of local languages
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT03749291
Start Date
January 1 2019
End Date
December 31 2023
Last Update
December 2 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Faculty of Medicine, C/ Sant Llorenç 21
Reus, Tarragona, Spain, 43201
2
Iispv- Hospital Sant Joan de Reus
Reus, Tarragona, Spain, E43204
3
Hospital de Tarragona Joan XXIII
Tarragona, Spain, 43005