Microbial ColonizationMICROBEkidsNCT03749291
Motivational Intervention on the Gut Microbiota of Obese Children
A study testing Obemat2.0 therapy and Usual Clinical Practice in people with Microbial Colonization, run by Institut Investigacio Sanitaria Pere Virgili at 3 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Obemat2.0 therapy and Usual Clinical Practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Jan 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Faculty of Medicine, C/ Sant Llorenç 21
Reus, Tarragona, 43201
Iispv- Hospital Sant Joan de Reus
Reus, Tarragona, E43204
Hospital de Tarragona Joan XXIII
Tarragona, 43005
About this study
Official title: Effect of a Motivational Intervention on the Gut Microbiota and the Components of the Metabolic Syndrome in a Population of Obese Children
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).
Read the 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)
- Conditions
- Microbial Colonization
- Being tested
- Obemat2.0 therapy, Usual Clinical Practice
- Keywords
- Childhood Obesity, Motivational therapy, Dietary Patterns, Cardiovascular disease risk
- Medical subject headings
- Communicable Diseases, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obemat2.0 therapyOther
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.
Usual Clinical PracticeOther
Also called Usual Reccomendations given at the pediatric consultations
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Usual Clinical Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal microbial diversity (diversity index like Gini-Simpson)
Effect of the intervention on increments of Fecal microbial diversity
Measured: 12 (+3) months
Secondary outcomes (4)
Fecal Short Chain Fatty Acids: butyrate acid (μg)
Effect of the intervention and microbiota on increments Short Chain Fatty Acids
Measured: 12 (+3) months
Fecal Short Chain Fatty Acids: acetic acid (μg)
Effect of the intervention and microbiota on increments Short Chain Fatty Acids
Measured: 12 (+3) months
Fecal Short Chain Fatty Acids: propionic acid (μg)
Effect of the intervention and microbiota on increments Short Chain Fatty Acids
Measured: 12 (+3) months
Akkermansia Muciniphila (cfu)
Effect of the intervention on increments of Akkermansia Muciniphila in feces
Measured: 12 (+3) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Joan XXIII de Tarragona., Hospital Universitari Sant Joan de Reus, University Rovira i Virgili
- Responsible party
- Principal investigator, Veronica Luque, Institut Investigacio Sanitaria Pere Virgili
- Investigators
- Veronica Luque, Principal investigator, Institut d'Investigació Sanitària Pere Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749291
- Sponsor's protocol ID
- PI18/00226
- Acronym
- MICROBEkids
- Status last verified
- May 2024
- First submitted
- 8 Oct 2018
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35777107Alcazar M, Luque V, Ferre N, Munoz-Hernando J, Gispert-Llaurado M, Closa-Monasterolo R, Feliu A, Castillejo G, Escribano J. Children's gut microbiota predicts the efficacy of obesity treatment. Gut Microbes. 2026 Dec 31;18(1):2631824. doi: 10.1080/19490976.2026.2631824. Epub 2026 Feb 19.
PubMed 41711285
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Motivational Intervention on the Gut Microbiota and the Components of the Metabolic Syndrome in a Population of Obese Children
- ClinicalTrials.gov ID
- NCT03749291
- Acronym / sponsor ID
- MICROBEkids / PI18/00226
- Conditions
- Microbial Colonization
- Keywords
- Childhood Obesity, Motivational therapy, Dietary Patterns, Cardiovascular disease risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Collaborators
- Hospital Universitari Joan XXIII de Tarragona., Hospital Universitari Sant Joan de Reus, University Rovira i Virgili
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obemat2.0 Intervention Group | Experimental | Other: Obemat2.0 therapyObese 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) |
| Control Group | Active comparator | Other: Usual Clinical PracticeObese 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) |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obemat2.0 therapyLifestyle (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 | Obemat2.0 Intervention Group |
| Usual Clinical PracticeAlso: Usual Reccomendations given at the pediatric consultationsLifestyle (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. | Other | Control Group |
Primary outcome
Fecal microbial diversity (diversity index like Gini-Simpson)
Time frame: 12 (+3) months
Effect of the intervention on increments of Fecal microbial diversity
4 secondary outcomes
Fecal Short Chain Fatty Acids: butyrate acid (μg)
Time frame: 12 (+3) months
Fecal Short Chain Fatty Acids: acetic acid (μg)
Time frame: 12 (+3) months
Fecal Short Chain Fatty Acids: propionic acid (μg)
Time frame: 12 (+3) months
Akkermansia Muciniphila (cfu)
Time frame: 12 (+3) months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Results publication: PubMed 35777107Alcazar 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.
- Derived from this study: PubMed 41711285Alcazar M, Luque V, Ferre N, Munoz-Hernando J, Gispert-Llaurado M, Closa-Monasterolo R, Feliu A, Castillejo G, Escribano J. Children's gut microbiota predicts the efficacy of obesity treatment. Gut Microbes. 2026 Dec 31;18(1):2631824. doi: 10.1080/19490976.2026.2631824. Epub 2026 Feb 19.
- Preliminar (baseline) resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronica Luque principal investigator
Institut d'Investigació Sanitària Pere Virgili
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obemat2.0 therapy and Usual Clinical Practice in people with Microbial Colonization, run by Institut Investigacio Sanitaria Pere Virgili at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal microbial diversity (diversity index like Gini-Simpson) (time frame: 12 (+3) months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03749291, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.