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NCT Number: NCT03749291

Motivational Intervention on the Gut Microbiota 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).

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Key information

Conditions

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

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, C/ Sant Llorenç 21, Reus, Tarragona, Spain

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: Usual Reccomendations given at the pediatric consultations

Primary outcomes

  1. Fecal microbial diversity (diversity index like Gini-Simpson)

    Time frame: 12 (+3) months

    Effect of the intervention on increments of Fecal microbial diversity

Secondary outcomes

  1. Fecal Short Chain Fatty Acids: butyrate acid (μg)

    Time frame: 12 (+3) months

    Effect of the intervention and microbiota on increments Short Chain Fatty Acids

  2. Fecal Short Chain Fatty Acids: acetic acid (μg)

    Time frame: 12 (+3) months

    Effect of the intervention and microbiota on increments Short Chain Fatty Acids

  3. Fecal Short Chain Fatty Acids: propionic acid (μg)

    Time frame: 12 (+3) months

    Effect of the intervention and microbiota on increments Short Chain Fatty Acids

  4. Akkermansia Muciniphila (cfu)

    Time frame: 12 (+3) months

    Effect of the intervention on increments of Akkermansia Muciniphila in feces

Sponsors and collaborators

Lead sponsor

Institut Investigacio Sanitaria Pere Virgili

Other

Collaborators

  • Hospital Universitari Joan XXIII de Tarragona.
  • Hospital Universitari Sant Joan de Reus
  • University Rovira i Virgili

Registry information

Official study title

Effect of a Motivational Intervention on the Gut Microbiota and the Components of the Metabolic Syndrome in a Population of Obese Children

Acronym: MICROBEkids

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Nov 21, 2018
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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