Motivational Intervention on the Gut Microbiota of Obese Children (MICROBEkids)
Primary Purpose
Microbial Colonization
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Obemat2.0 therapy
Usual Clinical Practice
Sponsored by
About this trial
This is an interventional treatment trial for Microbial Colonization focused on measuring Childhood Obesity, Motivational therapy, Dietary Patterns, Cardiovascular disease risk
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Faculty of Medicine, C/ Sant Llorenç 21
- Iispv- Hospital Sant Joan de Reus
- Hospital de Tarragona Joan XXIII
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Obemat2.0 Intervention Group
Control Group
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
Fecal microbial diversity (diversity index like Gini-Simpson)
Effect of the intervention on increments of Fecal microbial diversity
Secondary Outcome Measures
Fecal Short Chain Fatty Acids: butyrate acid (μg)
Effect of the intervention and microbiota on increments Short Chain Fatty Acids
Fecal Short Chain Fatty Acids: acetic acid (μg)
Effect of the intervention and microbiota on increments Short Chain Fatty Acids
Fecal Short Chain Fatty Acids: propionic acid (μg)
Effect of the intervention and microbiota on increments Short Chain Fatty Acids
Akkermansia Muciniphila (cfu)
Effect of the intervention on increments of Akkermansia Muciniphila in feces
Full Information
NCT ID
NCT03749291
First Posted
October 8, 2018
Last Updated
September 15, 2020
Sponsor
Institut Investigacio Sanitaria Pere Virgili
Collaborators
Hospital Universitari Joan XXIII de Tarragona., Hospital Universitari Sant Joan de Reus, University Rovira i Virgili
1. Study Identification
Unique Protocol Identification Number
NCT03749291
Brief Title
Motivational Intervention on the Gut Microbiota of Obese Children
Acronym
MICROBEkids
Official Title
Effect of a Motivational Intervention on the Gut Microbiota and the Components of the Metabolic Syndrome in a Population of Obese Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut Investigacio Sanitaria Pere Virgili
Collaborators
Hospital Universitari Joan XXIII de Tarragona., Hospital Universitari Sant Joan de Reus, University Rovira i Virgili
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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 least in part) of changes in the microbiota.
Other secondary hypothesis to be demonstrated are:
The microbiota (before the treatment) could be a determinant factor of the metabolic syndrome (inflamation, serum lipid profile, insulin resistance) being a key feature differentiating the metabolically healthy obese from the obese with metabolic syndrome.
A dietary pattern rich in vegetables and fruits is associated to a gut microbiota profile preventing the metabolic syndrome
How these hypothesis will be demonstrated? A motivational structured intervention to reduce weight is applied (under randomized clustered design) to obese children, that are compared to an active intervention (not structured) provided by health care professionals, both groups during 12 months (+3).
A baseline and final assessment (before and after the intervention) are performed, in which the following information is collected:
Socioeconomics
Anthropometry (weight, height, waist circumference) to calculate the obesity degree (BMI z- score) and the presence of abdominal obesity
Body composition: deuterium dilution (in a subsample), bioimpedance, Dual X-Ray Absorptiometry and Air displacement pletismography (BodPod)
Blood sample drawn: to analyze lipids profile and insulin resistance
Fecal sample: the gut microbiota diversity and the presence of specific bacteria will be analyzed
Dietary intake by a food frequency questionnaire: diet will be analyzed as dietary patterns
Systolic and diastolic blood pressure (which will be adjusted as z-score)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization
Keywords
Childhood Obesity, Motivational therapy, Dietary Patterns, Cardiovascular disease risk
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
319 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Obemat2.0 Intervention Group
Arm Type
Experimental
Arm Description
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)
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Obemat2.0 therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Clinical Practice
Other Intervention Name(s)
Usual Reccomendations given at the pediatric consultations
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fecal microbial diversity (diversity index like Gini-Simpson)
Description
Effect of the intervention on increments of Fecal microbial diversity
Time Frame
12 (+3) months
Secondary Outcome Measure Information:
Title
Fecal Short Chain Fatty Acids: butyrate acid (μg)
Description
Effect of the intervention and microbiota on increments Short Chain Fatty Acids
Time Frame
12 (+3) months
Title
Fecal Short Chain Fatty Acids: acetic acid (μg)
Description
Effect of the intervention and microbiota on increments Short Chain Fatty Acids
Time Frame
12 (+3) months
Title
Fecal Short Chain Fatty Acids: propionic acid (μg)
Description
Effect of the intervention and microbiota on increments Short Chain Fatty Acids
Time Frame
12 (+3) months
Title
Akkermansia Muciniphila (cfu)
Description
Effect of the intervention on increments of Akkermansia Muciniphila in feces
Time Frame
12 (+3) months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica Luque
Organizational Affiliation
Institut d'Investigació Sanitària Pere Virgili
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, C/ Sant Llorenç 21
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43201
Country
Spain
Facility Name
Iispv- Hospital Sant Joan de Reus
City
Reus
State/Province
Tarragona
ZIP/Postal Code
E43204
Country
Spain
Facility Name
Hospital de Tarragona Joan XXIII
City
Tarragona
ZIP/Postal Code
43005
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Motivational Intervention on the Gut Microbiota of Obese Children
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