Evaluation of the correlation between diet quality, weight status, and mental health in schoolchildren, with an emphasis on the identification of plasma biomarkers.
| ISRCTN | ISRCTN12172320 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12172320 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Tecnológico de Monterrey |
| Funder | Instituto Tecnológico y de Estudios Superiores de Monterrey |
- Submission date
- 09/03/2025
- Registration date
- 12/03/2025
- Last edited
- 10/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Obesity and mental health issues are growing concerns in children worldwide. Poor diet and excess weight can affect a child’s physical and mental well-being. However, it’s not always easy to tell when a child’s weight and diet might lead to problems later on. Many children with excess body fat are not diagnosed with obesity because their BMI may appear normal. This study will help us better understand these connections, particularly by identifying children who may be at risk despite having a normal BMI. This study aims to explore how children's diet quality, weight, and mental health are connected.
Who can participate?
Children aged 6-11 years old who attend school and have parental consent.
What does the study involve?
The study will involve a one-time evaluation where the InBody device will be used to measure body composition (including fat and muscle mass). The study will also use questionnaires to assess the children's mental health and gather information about their diet. Finally, a blood sample will be collected to check for plasma biomarkers that can give us further insight into their metabolic and inflammatory health.
What are the possible benefits and risks of participating?
The main goal of this study is to identify early signs of potential health problems related to diet, weight, and mental health. Understanding these connections better will help prevent obesity and related conditions in children. This research will contribute to improving children's health and well-being.
Participation in this study has minimal risks, including slight discomfort during blood sampling and potential emotional discomfort when responding to mental health questionnaires. All materials, including questionnaires and consent forms, are provided in Spanish. Participants will receive professional support if needed, and confidentiality is strictly maintained.
Where is the study run from?
The Institute for Obesity Research at Tecnológico de Monterrey, Mexico
When is the study starting and how long is it expected to run for?
May 2024 to September 2025
Who is funding the study?
The Institute for Obesity Research at Tecnológico de Monterrey, Mexico
Who is the main contact?
Dr Cipatli Ayuzo (Principal Investigator), cipatli@tecsalud.mx
Contact information
Public, Scientific, Principal investigator
Tecnológico de Monterrey
Batallon De San Patricio 1112
San Pedro Garza García
66440
Mexico
 ORCID ID |
0000-0002-8110-3532 |
|---|---|
| Phone | +528181850805 |
| cipatli@tecsalud.mx |
Scientific
Tecnológico de Monterrey
Batallon De San Patricio 1112
San Pedro
66440
Mexico
| ORCID ID |
0000-0002-0076-5738 |
|---|---|
| Phone | +528182533814 |
| perla.perez.trevino@tec.mx |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Non-interventional single-center cross-sectional study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Evaluating the new 2025 obesity classification framework in pediatric athletes: a comparative study with traditional BMI-based classification |
| Study objectives | The 2025 obesity classification provides a more accurate assessment of pediatric obesity by distinguishing excess adiposity from muscle mass. This new approach will improve the identification of children at risk for metabolic complications, including those with a normal BMI but excess body fat, allowing for earlier intervention and targeted management strategies. |
| Ethics approval(s) |
1. Approved 24/05/2024, Ethics Committee of the Hospital la Mision (Ave Hospital 112, Monterrey, 64718, Mexico; +52 8114924050; investigacion@hospitallamision.com), ref: HZHRMA-te01-001 2. Approved 30/05/2024, Hospital Zambrano (Batallon De San Patricio 1112, San Pedro, 66440, Mexico; +528188880000; gdejesus@tec.mx), ref: hzhrma-te01-001 |
| Health condition(s) or problem(s) studied | Evaluation of nutritional status in Mexican children |
| Intervention | This non-interventional single-center cross-sectional study will evaluate the correlation between diet quality, weight status, and mental health in schoolchildren. Participants will undergo a single assessment, including dietary intake analysis, anthropometric measurements, and mental health screening. Additionally, plasma biomarkers related to metabolic and inflammatory status will be analyzed. Statistical analyses will explore associations between these variables to identify potential risk factors and early indicators of health outcomes. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Diet quality and weight status (including excess adiposity and BMI) in schoolchildren measured using the InBody device, which uses bioelectrical impedance analysis (BIA) at one timepoint |
| Key secondary outcome measure(s) |
1. Diet quality measured using the Children’s Diet Quality Questionnaire (Cuestionario de Calidad de la Dieta en Niños, validated in Spanish) at baseline. |
| Completion date | 04/09/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 11 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Total final enrolment | 111 |
| Key inclusion criteria | 1. Schoolchildren aged 6-11 years 2. Parental/guardian consent for participation 3. Ability to follow study procedures, including completing questionnaires and undergoing assessments 4. Willingness to provide a blood sample for plasma biomarker analysis |
| Key exclusion criteria | 1. Current chronic medical conditions that could affect weight, diet, or mental health (e.g., diabetes, psychiatric disorders, metabolic conditions) 2. Use of medications or supplements that may significantly alter metabolic or mental health status |
| Date of first enrolment | 04/09/2024 |
| Date of final enrolment | 04/12/2024 |
Locations
Countries of recruitment
- Mexico
Study participating centre
San Pedro
66440
Mexico
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The study will use RedCap for secure data collection and management, ensuring participant confidentiality. Individual participant data will not be shared publicly or with third parties without explicit consent, except in cases required by law or ethical review. De-identified data may be shared with other researchers upon request, in accordance with institutional guidelines and ethical standards, and only for research purposes related to obesity, nutrition, or mental health. Any data sharing will be done through secure platforms, ensuring privacy and data protection. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 22/05/2025 | 27/05/2025 | Yes | No | |
| Results article | 22/05/2025 | 10/06/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1 | 12/04/2024 | 12/03/2025 | No | No |
| Protocol file | 12/03/2025 | No | No |
Additional files
- 46970_Investigator Brochure for the TecMind01 Protocol_v1_12April2024.pdf
- Protocol file
- 46970_Protocol.pdf
- Protocol file
Editorial Notes
10/06/2025: Publication reference added.
27/05/2025: Publication reference added.
13/03/2025: Internal review.
12/03/2025: Study's existence confirmed by the Ethics Committee of the Hospital la Mision.
