Motivational Intervention on the Gut Microbiota of Obese Children

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 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).

Conditions

• Microbial Colonization

Interventions

OTHER

Obemat2.0 therapy

Lifestyle (diet \& physical activity) structured recommendations through a motivational interview. Duration: 12(+3) months Description: 1 visit/month \& 3 Workshops in primary care centers Providers: pediatricians and nurses trained to perform motivational interview The interviews are structured as follows: First, checking the accomplishment of objectives to motivate the participant. Second, a specific topic per visit is explained to the participant. Third, a task related to the topic (i.e. to plan a weekly menu for the family) is given to be brought back at the next visit. 4th. Objectives about diet, weight \& physical activity are defined to be accomplished until the next visit.

OTHER

Usual Clinical Practice

Lifestyle (diet and physical activity) Duration: 12 (+3) months Description: 1visit/month to the primary care centers. Providers: pediatricians \& nurses. Children assigned to the control group receive the usual treatment conducted in primary care centers based on the Clinical Practice Guidelines on the Prevention and Treatment of Child and Adolescent Obesity \[Spanish Ministry of Science and Innovation\], 2009). At visits, the family receive recommendations to carry out a balanced diet, to provide a moderate energy reduction from the previous intake. An increase in physical activity, both in terms of leisure activity, as sports is advised.

Sponsors & Collaborators

• Hospital Universitari Joan XXIII de Tarragona.

  collaborator OTHER

• Hospital Universitari Sant Joan de Reus

  collaborator OTHER

• University Rovira i Virgili

  collaborator OTHER

• Institut Investigacio Sanitaria Pere Virgili

  lead OTHER

Principal Investigators

• Veronica Luque · Institut d'Investigació Sanitària Pere Virgili

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-01

Primary Completion

2021-12-31

Completion

2023-12-31

Countries

• Spain

Study Locations