Motivational Intervention on the Gut Microbiota of Obese Children

NCT03749291 | Completed

• 1 other identifier: PI18/00226
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 3

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 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

Keywords

Childhood Obesity; Motivational therapy; Dietary Patterns; Cardiovascular disease risk

Outcome Measures

Primary Outcomes (1)

• Fecal microbial diversity (diversity index like Gini-Simpson)

  Effect of the intervention on increments of Fecal microbial diversity

  12 (+3) months

Secondary Outcomes (4)

• Fecal Short Chain Fatty Acids: butyrate acid (μg)

  12 (+3) months

• Fecal Short Chain Fatty Acids: acetic acid (μg)

  12 (+3) months

• Fecal Short Chain Fatty Acids: propionic acid (μg)

  12 (+3) months

• Akkermansia Muciniphila (cfu)

  12 (+3) months

Study Arms (2)

Obemat2.0 Intervention Group

EXPERIMENTAL

Obese children (BMI \>97th percentile of the Spanish curves from Hernández 1988) Ages: 8 to 13 at baseline (9 to 15y at the end of the intervention)

Other: Obemat2.0 therapy

Control Group

ACTIVE COMPARATOR

Obese children (BMI \>97th percentile of the Spanish curves from Hernández 1988) Ages: 8 to 13 at baseline (9 to 15y at the end of the intervention)

Other: Usual Clinical Practice

Interventions

Obemat2.0 therapy OTHER

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.

Obemat2.0 Intervention Group

Usual Clinical Practice OTHER

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.

Also known as: Usual Reccomendations given at the pediatric consultations

Control Group

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead
• Hospital Universitari Joan XXIII de Tarragona.: collaborator
• Hospital Universitari Sant Joan de Reus: collaborator
• University Rovira i Virgili: collaborator

Study Sites (3)

Faculty of Medicine, C/ Sant Llorenç 21

Reus, Tarragona, 43201, Spain

Location

Iispv- Hospital Sant Joan de Reus

Reus, Tarragona, E43204, Spain

Location

Hospital de Tarragona Joan XXIII

Tarragona, 43005, Spain

Location

Related Publications (1)

• Alcazar M, Escribano J, Ferre N, Closa-Monasterolo R, Selma-Royo M, Feliu A, Castillejo G, Luque V; Obemat2.0 Study Group. Gut microbiota is associated with metabolic health in children with obesity. Clin Nutr. 2022 Aug;41(8):1680-1688. doi: 10.1016/j.clnu.2022.06.007. Epub 2022 Jun 15.

  PMID: 35777107 RESULT

Related Links

• Preliminar (baseline) results

MeSH Terms

Conditions

Communicable Diseases; Pediatric Obesity

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Veronica Luque

  Institut d'Investigació Sanitària Pere Virgili

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. PhD

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: November 21, 2018
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: December 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)