Childhood ObesityNCT07185789
Multidimensional Intervention in Mexican Schoolchildren
A study testing Healthy and Sustainable Eating, Movement behaviors and Psychosocial determinants in people with Childhood Obesity and Pediatric Obesity, run by Mexican National Institute of Public Health at 1 site in Mexico.
Trial summary
The aims is to evaluate the effects of an multidimensional intervention on the physical-built and social environment around schools and the nutritional status of the school population, through a randomized community trial, in schools in 3 states of the Mexican Republic, using anthropometric indicators, biological… Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Pediatric Obesity, Childhood Overweight
- What is being tested?
- Healthy and Sustainable Eating, Movement behaviors and Psychosocial determinants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteMexico
- Study dates
- 7 Nov 2023to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Fourth grade elementary schools children from schools that belong to Federal entities: Campeche, Morelos and Mexico City, with morning schedule, from 8:00 to 12:30 or extended schedule, from 8:00 to 14:00hrs.
- For Morelos State, elementary schools will be sought to be private, with at least 1000 enrollement students, with morning schedule, from 8:00 to 12:30 or extended schedule, from 8:00 to 14:00hrs.
Who cannot join
- Children that don´t correspond to the selected shifts.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Salud Pública
Cuernavaca, Morelos, 62100
SIMON BARQUERA, PhD, sbarquera@insp.mx
About this study
Official title: Multidimensional Intervention to Improve Healthy Lifestyle Practices and Nutrition and Health Status in Mexican Schoolchildren: Development of an Intervention Platform, Randomized Clinical Trial and Scaling Proposal
The aims is to evaluate the effects of an multidimensional intervention on the physical-built and social environment around schools and the nutritional status of the school population, through a randomized community trial, in schools in 3 states of the Mexican Republic, using anthropometric indicators, biological, psychological, behavioral and environmental.
The main questions it aims to answer are:
- What are the main risk and protective factors for overweight and obesity in the school environment and in the environments around schools in primary education schools in three states of the Mexican Republic?
- Is there a relationship between risky eating behaviors and the body mass index of schoolchildren?
- Are the strategies that are being implemented effective in reducing the presence of risk factors and increasing the presence of protective factors for overweight and obesity in the school environment and in the environments around schools?
- Are the strategies that are being implemented effective in reducing the presence of risk factors and increasing the protective factors for overweight and obesity in the family environment?
Read the detailed description
This is a project designed and approved to be carried out in 4 stages. The project has financing from the health sector fund and also an extension to end on January 11, 2025. The objective is to evaluate the effects of a multidimensional intervention (MI) on the physical-built and social environment around schools, as well as, on the nutritional status of the school population, through a community trial in schools in 3 states of the Mexican Republic (Campeche, Mexico City and Morelos). The impact will be measured through anthropometric, biological, psychological, behavioral and environmental indicators. The target population of the intervention will be students between 9-12 years old who are in the 4th grade of primary school.
Stage 1. Situational diagnosis. Duration: 12 months. In the design of health promotion interventions, situational diagnostic assessment is necessary to be able to design an intervention adapted to the context and real needs of the target population. This stage of the project also allows us to identify previous experiences and derive from them available evidence on interventions that have been implemented in other populations. Likewise, it is necessary to identify the health problems of the population to which the intervention to be designed is directed, as well as the existing policies and programs and the participation of the target population to which the intervention to be designed is aimed.
Stage 2. Design and development of the multidimensional intervention and evaluation instruments. Duration: 12 months. The information generated from the situational diagnosis will serve to design the multidimensional intervention of this proposal, which will include different levels of intervention such as school, around school, home and community. The components of this stage are the following: 1) Final design of the multidimensional intervention; and 2) Definition of the components of the multidimensional intervention, which include: a) Actions to ensure a healthy food environment; b) Comprehensive Physical Activity Program; c) Teacher training; d) Motivation of teachers; e) Educational materials with a social marketing focus, short or simple message service (SMS), printed or audiovisual material; f) Implementation logistics; g) Development of instruments necessary for intervention; h) Validation or pilot testing of the intervention materials.
Stage 3. Implementation, monitoring and evaluation of the multidimensional intervention. Duration: 10 months. The final design of the multidimensional intervention that will be implemented during this stage will depend on the modifications made in the stages described above. This stage consists of the following phases: 1) Randomization, 2) Initial evaluation, 3) Beginning of the intervention, 4) Monitoring and evaluation of the process and 5) Final evaluation.
Stage 4. Institutionalization of the intervention. Duration: 12 months. In the final stage, an analysis and formulation of recommendations will be carried out for the escalation and incorporation of the intervention to the Ministry of Public Education (SEP, for its acronym in Spanish).
The study consists of a community trial in 24 schools in 3 states of the Mexican Republic (Campeche, Morelos and Mexico City) and a parallel randomized clinical trial in 4 of the schools in Cuernavaca, Morelos. Both studies together will address the questions raised in the previous section.
- Conditions
- Childhood Obesity, Pediatric Obesity, Childhood Overweight
- Being tested
- Healthy and Sustainable Eating, Movement behaviors, Psychosocial determinants
- Keywords
- Childhood obesity, School children
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy and Sustainable EatingBehavioural
Also called Movement behaviors, Psychosocial determinants
Animated projections, snacks that incorporate fruits and/or vegetables, measuring their hydration status through images where they can observe the color of their urine and relate it to the amount of plain water they have consumed, as well as activities through the mobile messaging platform, WhatsApp.
Movement behaviorsBehavioural
Animated projections, snacks that incorporate fruits and/or vegetables, measuring their hydration status through images where they can observe the color of their urine and relate it to the amount of plain water they have consumed, as well as activities through the mobile messaging platform, WhatsApp.
Psychosocial determinantsBehavioural
Workshops on key topics of psychosocial determinants in children, virtual workshops on topics of psychosocial determinants such as obesity and healthy eating.
| Study group | Role | What they receive |
|---|---|---|
| Intervención Multidimensional | Active comparator | The multidimensional intervention will be received in 10 schools in 3 states of Mexico (Campeche, Mexico City and Morelos). In these schools, an initial diagnosis of the environment, monitoring and evaluation of the implemented strategies will be carried out. Subsequently, a baseline measurement will be carried out, where anthropometric, behavioral and environmental modification indicators will be evaluated, including the measurement of body composition through dual x-ray absorption densitometry (DXA), cardiometabolic health indicators such as glycated hemoglobin (HbA1c), lipid profile, liver function and biological markers; inflammation markers. The intervention will include activities related to: A) Healthy and sustainable eating; B) Movement behaviors; C) Psychosocial determinants. Finally, a final measurement will be carried out where the same variables as in the initial measurement will be evaluated. Receives: Behavioral: Healthy and Sustainable Eating; Behavioral: Movement behaviors; Behavioral: Psychosocial determinants |
| Control | No intervention | Multidimensional intervention will not be received. In these schools, an initial diagnosis of the environment will be carried out, monitoring and evaluation of the strategies implemented and a more in-depth initial and basal measurement will be carried out, using anthropometric, behavioral and environmental modification indicators, including the measurement of body composition through dual x-ray absorption densitometry (DXA), cardiometabolic health indicators such as glycated hemoglobin (HbA1c), lipid profile, liver function and biological markers; inflammation markers. A final measurement will be carried out to compare the results. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic and Lipid Profile
This outcome is designed to provide a fundamental assessment of the participant's cardiometabolic health status at the beginning of the study. It focuses on measuring key circulating molecules that are central to energy metabolism and cardiovascular risk.
To achieve this, we will collect blood samples and analyze them for the core analytes that constitute a standard lipid panel and metabolic check:
Glucose (mg/dL) Total Cholesterol (mg/dL) HDL-c (%) Triglycerides (mg/dL)
The concentration of each of these analytes will be determined using Enzymatic Spectrophotometry.
Measured: Baseline and after 6 moths
Markers of Inflammation
We will measure the levels of Leptin, Adiponectin, IL-6, Galectin-3, HbA1c. We ELISA for the proteins, HPLC for HbA1c.
Units: The results for the proteins will be reported in ng/mL, HbA1c as a percentage (%).
Measured: Baseline and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start7 Nov 2023
- Primary completion28 Jul 2025
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mexican National Institute of Public Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Edgar Denova Gutierrez, Mexican National Institute of Public Health
- Investigators
- Simon Barquera Cervera, PhD, Study director, National Institute of public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185789
- Sponsor's protocol ID
- MexicanNIPH
- Status last verified
- Sep 2025
- First submitted
- 7 Apr 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential information
Publications
Bonvecchio A, Safdie M, Monterrubio EA, Gust T, Villalpando S, Rivera JA. Overweight and obesity trends in Mexican children 2 to 18 years of age from 1988 to 2006. Salud Publica Mex. 2009;51 Suppl 4:S586-94. doi: 10.1590/s0036-36342009001000013.
PubMed 20464234Barquera S, Campos I, Rivera JA. Mexico attempts to tackle obesity: the process, results, push backs and future challenges. Obes Rev. 2013 Nov;14 Suppl 2:69-78. doi: 10.1111/obr.12096.
PubMed 24103026Rivera JA, Irizarry LM, Gonzalez-de Cossio T. Overview of the nutritional status of the Mexican population in the last two decades. Salud Publica Mex. 2009;51 Suppl 4:S645-56. doi: 10.1590/s0036-36342009001000020. No abstract available.
PubMed 20464241Hernandez-Cordero S, Cuevas-Nasu L, Moran-Ruan MC, Mendez-Gomez Humaran I, Avila-Arcos MA, Rivera-Dommarco JA. Overweight and obesity in Mexican children and adolescents during the last 25 years. Nutr Diabetes. 2017 Mar 13;7(3):e247. doi: 10.1038/nutd.2016.52.
PubMed 28287630Incledon E, Wake M, Hay M. Psychological predictors of adiposity: systematic review of longitudinal studies. Int J Pediatr Obes. 2011 Jun;6(2-2):e1-11. doi: 10.3109/17477166.2010.549491. Epub 2011 Jan 19.
PubMed 21247271O'Dea JA, Caputi P. Association between socioeconomic status, weight, age and gender, and the body image and weight control practices of 6- to 19-year-old children and adolescents. Health Educ Res. 2001 Oct;16(5):521-32. doi: 10.1093/her/16.5.521.
PubMed 11675800Palma-Coca O, Hernandez-Serrato MI, Villalobos-Hernandez A, Unikel-Santoncini C, Olaiz-Fernandez G, Bojorquez-Chapela I. Association of socioeconomic status, problem behaviors, and disordered eating in Mexican adolescents: results of the Mexican National Health and Nutrition Survey 2006. J Adolesc Health. 2011 Oct;49(4):400-6. doi: 10.1016/j.jadohealth.2011.01.019. Epub 2011 May 20.
PubMed 21939871
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Intervention to Improve Healthy Lifestyle Practices and Nutrition and Health Status in Mexican Schoolchildren: Development of an Intervention Platform, Randomized Clinical Trial and Scaling Proposal
- ClinicalTrials.gov ID
- NCT07185789
- Acronym / sponsor ID
- MexicanNIPH
- Conditions
- Childhood Obesity, Pediatric Obesity, Childhood Overweight
- Keywords
- Childhood obesity, School children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mexican National Institute of Public HealthOther government
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 22 Sep 2025 (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.
The aims is to evaluate the effects of an multidimensional intervention on the physical-built and social environment around schools and the nutritional status of the school population, through a randomized community trial, in schools in 3 states of the Mexican Republic, using anthropometric indicators, biological, psychological, behavioral and environmental.
The main questions it aims to answer are:
- What are the main risk and protective factors for overweight and obesity in the school environment and in the environments around schools in primary education schools in three states of the Mexican Republic?
- Is there a relationship between risky eating behaviors and the body mass index of schoolchildren?
- Are the strategies that are being implemented effective in reducing the presence of risk factors and increasing the presence of protective factors for overweight and obesity in the school environment and in the environments around schools?
- Are the strategies that are being implemented effective in reducing the presence of risk factors and increasing the protective factors for overweight and obesity in the family environment?
Detailed description
This is a project designed and approved to be carried out in 4 stages. The project has financing from the health sector fund and also an extension to end on January 11, 2025. The objective is to evaluate the effects of a multidimensional intervention (MI) on the physical-built and social environment around schools, as well as, on the nutritional status of the school population, through a community trial in schools in 3 states of the Mexican Republic (Campeche, Mexico City and Morelos). The impact will be measured through anthropometric, biological, psychological, behavioral and environmental indicators. The target population of the intervention will be students between 9-12 years old who are in the 4th grade of primary school.
Stage 1. Situational diagnosis. Duration: 12 months. In the design of health promotion interventions, situational diagnostic assessment is necessary to be able to design an intervention adapted to the context and real needs of the target population. This stage of the project also allows us to identify previous experiences and derive from them available evidence on interventions that have been implemented in other populations. Likewise, it is necessary to identify the health problems of the population to which the intervention to be designed is directed, as well as the existing policies and programs and the participation of the target population to which the intervention to be designed is aimed.
Stage 2. Design and development of the multidimensional intervention and evaluation instruments. Duration: 12 months. The information generated from the situational diagnosis will serve to design the multidimensional intervention of this proposal, which will include different levels of intervention such as school, around school, home and community. The components of this stage are the following: 1) Final design of the multidimensional intervention; and 2) Definition of the components of the multidimensional intervention, which include: a) Actions to ensure a healthy food environment; b) Comprehensive Physical Activity Program; c) Teacher training; d) Motivation of teachers; e) Educational materials with a social marketing focus, short or simple message service (SMS), printed or audiovisual material; f) Implementation logistics; g) Development of instruments necessary for intervention; h) Validation or pilot testing of the intervention materials.
Stage 3. Implementation, monitoring and evaluation of the multidimensional intervention. Duration: 10 months. The final design of the multidimensional intervention that will be implemented during this stage will depend on the modifications made in the stages described above. This stage consists of the following phases: 1) Randomization, 2) Initial evaluation, 3) Beginning of the intervention, 4) Monitoring and evaluation of the process and 5) Final evaluation.
Stage 4. Institutionalization of the intervention. Duration: 12 months. In the final stage, an analysis and formulation of recommendations will be carried out for the escalation and incorporation of the intervention to the Ministry of Public Education (SEP, for its acronym in Spanish).
The study consists of a community trial in 24 schools in 3 states of the Mexican Republic (Campeche, Morelos and Mexico City) and a parallel randomized clinical trial in 4 of the schools in Cuernavaca, Morelos. Both studies together will address the questions raised in the previous section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervención Multidimensional | Active comparator | Behavioral: Healthy and Sustainable Eating, Behavioral: Movement behaviors, Behavioral: Psychosocial determinantsThe multidimensional intervention will be received in 10 schools in 3 states of Mexico (Campeche, Mexico City and Morelos). In these schools, an initial diagnosis of the environment, monitoring and evaluation of the implemented strategies will be carried out. Subsequently, a baseline measurement will be carried out, where anthropometric, behavioral and environmental modification indicators will be evaluated, including the measurement of body composition through dual x-ray absorption densitometry (DXA), cardiometabolic health indicators such as glycated hemoglobin (HbA1c), lipid profile, liver function and biological markers; inflammation markers. The intervention will include activities related to: A) Healthy and sustainable eating; B) Movement behaviors; C) Psychosocial determinants. Finally, a final measurement will be carried out where the same variables as in the initial measurement will be evaluated. |
| Control | No intervention | –Multidimensional intervention will not be received. In these schools, an initial diagnosis of the environment will be carried out, monitoring and evaluation of the strategies implemented and a more in-depth initial and basal measurement will be carried out, using anthropometric, behavioral and environmental modification indicators, including the measurement of body composition through dual x-ray absorption densitometry (DXA), cardiometabolic health indicators such as glycated hemoglobin (HbA1c), lipid profile, liver function and biological markers; inflammation markers. A final measurement will be carried out to compare the results. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Fourth grade elementary schools children from schools that belong to Federal entities: Campeche, Morelos and Mexico City, with morning schedule, from 8:00 to 12:30 or extended schedule, from 8:00 to 14:00hrs.
- For Morelos State, elementary schools will be sought to be private, with at least 1000 enrollement students, with morning schedule, from 8:00 to 12:30 or extended schedule, from 8:00 to 14:00hrs.
Key exclusion criteria (1 listed)
- Children that don´t correspond to the selected shifts.
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 |
|---|---|---|
| Healthy and Sustainable EatingAlso: Movement behaviors, Psychosocial determinantsAnimated projections, snacks that incorporate fruits and/or vegetables, measuring their hydration status through images where they can observe the color of their urine and relate it to the amount of plain water they have consumed, as well as activities through the mobile messaging platform, WhatsApp. | Behavioural | Intervención Multidimensional |
| Movement behaviorsAnimated projections, snacks that incorporate fruits and/or vegetables, measuring their hydration status through images where they can observe the color of their urine and relate it to the amount of plain water they have consumed, as well as activities through the mobile messaging platform, WhatsApp. | Behavioural | Intervención Multidimensional |
| Psychosocial determinantsWorkshops on key topics of psychosocial determinants in children, virtual workshops on topics of psychosocial determinants such as obesity and healthy eating. | Behavioural | Intervención Multidimensional |
Primary outcome
Metabolic and Lipid Profile
Time frame: Baseline and after 6 moths
This outcome is designed to provide a fundamental assessment of the participant's cardiometabolic health status at the beginning of the study. It focuses on measuring key circulating molecules that are central to energy metabolism and cardiovascular risk. To achieve this, we will collect blood samples and analyze them for the core analytes that constitute a standard lipid panel and metabolic check: Glucose (mg/dL) Total Cholesterol (mg/dL) HDL-c (%) Triglycerides (mg/dL) The concentration of each of these analytes will be determined using Enzymatic Spectrophotometry.
Markers of Inflammation
Time frame: Baseline and after 6 months
We will measure the levels of Leptin, Adiponectin, IL-6, Galectin-3, HbA1c. We ELISA for the proteins, HPLC for HbA1c. Units: The results for the proteins will be reported in ng/mL, HbA1c as a percentage (%).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Background: PubMed 20464234Bonvecchio A, Safdie M, Monterrubio EA, Gust T, Villalpando S, Rivera JA. Overweight and obesity trends in Mexican children 2 to 18 years of age from 1988 to 2006. Salud Publica Mex. 2009;51 Suppl 4:S586-94. doi: 10.1590/s0036-36342009001000013.
- Background: PubMed 24103026Barquera S, Campos I, Rivera JA. Mexico attempts to tackle obesity: the process, results, push backs and future challenges. Obes Rev. 2013 Nov;14 Suppl 2:69-78. doi: 10.1111/obr.12096.
- Background: PubMed 20464241Rivera JA, Irizarry LM, Gonzalez-de Cossio T. Overview of the nutritional status of the Mexican population in the last two decades. Salud Publica Mex. 2009;51 Suppl 4:S645-56. doi: 10.1590/s0036-36342009001000020. No abstract available.
- Background: PubMed 28287630Hernandez-Cordero S, Cuevas-Nasu L, Moran-Ruan MC, Mendez-Gomez Humaran I, Avila-Arcos MA, Rivera-Dommarco JA. Overweight and obesity in Mexican children and adolescents during the last 25 years. Nutr Diabetes. 2017 Mar 13;7(3):e247. doi: 10.1038/nutd.2016.52.
- Background: PubMed 21247271Incledon E, Wake M, Hay M. Psychological predictors of adiposity: systematic review of longitudinal studies. Int J Pediatr Obes. 2011 Jun;6(2-2):e1-11. doi: 10.3109/17477166.2010.549491. Epub 2011 Jan 19.
- Background: PubMed 11675800O'Dea JA, Caputi P. Association between socioeconomic status, weight, age and gender, and the body image and weight control practices of 6- to 19-year-old children and adolescents. Health Educ Res. 2001 Oct;16(5):521-32. doi: 10.1093/her/16.5.521.
- Background: PubMed 21939871Palma-Coca O, Hernandez-Serrato MI, Villalobos-Hernandez A, Unikel-Santoncini C, Olaiz-Fernandez G, Bojorquez-Chapela I. Association of socioeconomic status, problem behaviors, and disordered eating in Mexican adolescents: results of the Mexican National Health and Nutrition Survey 2006. J Adolesc Health. 2011 Oct;49(4):400-6. doi: 10.1016/j.jadohealth.2011.01.019. Epub 2011 May 20.
- Individual participant dataSharing planned: No. Confidential information
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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.
Simon Barquera Cervera, PhD study director
National Institute of public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy and Sustainable Eating, Movement behaviors and Psychosocial determinants in people with Childhood Obesity and Pediatric Obesity, run by Mexican National Institute of Public Health at 1 site in Mexico.
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 1 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: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EDGAR DENOVA GUTIERREZ, PhD (5554322986, edenovag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic and Lipid Profile (time frame: Baseline and after 6 moths). The study lists 2 primary outcomes in all. 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 NCT07185789, which also lists 7 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 22 Sep 2025.