Sedentary BehaviorAcatlanNCT04679246
Participatory Intervention to Improve Nutrition and Physical Activity in Schoolchildren From Acatlán de Juárez, Jalisco
A study testing Participatory intervention in people with Sedentary Behavior and Adipose Tissue, run by Iberoamerican Institute of Sports Science and Human Movement at 1 site in Mexico.
Trial summary
This is a community project carried out jointly by the Technological Institute of Higher Studies of the West (ITESO), the University Center of Tonalá of the University of Guadalajara (CUTonalá) and the University Center of Health Sciences of the University of Guadalajara ( CUCS) with advice from the National Institute… Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Adipose Tissue, Child Obesity
- What is being tested?
- Participatory intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteMexico
- Study dates
- 1 May 2015to 1 Nov 2018
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 6 to 10 years of age (completed at the beginning of the study) attending public schools.
- Mothers and fathers of school-age children.
- Responsible for cooperatives and school canteens.
- Key actors and members of the different groups involved in the implementation of the strategies.
Who cannot join
- Chronic disease with a confirmed diagnosis (cancer, type 1 or type 2 diabetes).
- Physical limitations that could affect development and normal eating patterns.
- Use of medications that can influence energy consumption and expenditure (for example, antidepressant drugs, antipsychotics, steroids).
- Children who are or were in a weight reduction program in the last year.
- Use of medications or confirmed diagnosis of diseases that could alter laboratory values.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Iberoamerican Institute of Sports Science and Human Movement
Zapopan, Jalisco, 45128
About this study
This is a community project carried out jointly by the Technological Institute of Higher Studies of the West (ITESO), the University Center of Tonalá of the University of Guadalajara (CUTonalá) and the University Center of Health Sciences of the University of Guadalajara ( CUCS) with advice from the National Institute of Public Health (INSP), financed by the Tresmontes Lucchetti company and endorsed by the Jalisco Association of Nutritionists, AC (AJANUT). This project follows the provisions of the "National Strategy for the Prevention and Control of Overweight, Obesity and Diabetes" signed by the executive branch of the Federal Government. In particular, this project is inserted within the Public Health Strategy, in the strategic axis of Health Promotion and educational communication (while still having an impact on the axes of Epidemiological Surveillance and Prevention). In addition, it follows the agreement in which the general guidelines for the expenditure and distribution of food and beverages prepared and processed in the schools of the National Educational System were obtained, proposed by the Ministries of Health and Public Education. The aforementioned referrals are intended to protect and improve the health of Mexican children.
Read the detailed description
The project is a community trial that will last three years, which includes an intervention group and a control group of three schools each. Acatlán de Juárez has a total of 11 elementary schools.
The strategies will be implemented in collaboration with the authorities of the Acatlán de Juárez community, the school authorities, ITESO staff, CUTonalá, CUCS, and AJANUT. Key actors from both the school and community levels will be involved through the study to adapt the strategies socially and culturally to promote community project ownership. An initial study of the viability of the project and the current conditions of food and physical activity in school facilities will be carried out, as well as the perception of the community. The research team will design the contents and materials of the intervention taking into account the opinions and suggestions of the community and the results of the initial study. The schools of the control group will be chosen from the municipality of Villa Corona, Jalisco, which is similar to Acatlán de Juárez.
The strategies proposed for intervention by the research team, which will be agreed with the community, including the following:
- Surveillance in compliance with the regulation of the sale of food in school buildings, according to official guidelines
- Sensitization of children, parents, teachers (especially those in charge of the physical education class) and personnel in charge of the food supply (school cooperative), to improve acceptance and commitment to the regulation of the sale of food
- Training for the preparation of hygienic and healthy food for the personnel in charge of food sale
- Promotion of the consumption of simple water and healthy foods
- Rescue and promotion of the consumption of regional foods
- Reconditioning of the infrastructure for the consumption of simple water, free and healthy food, and the realization of physical activity
- Organization of events and support in the coordination of groups that promote physical activity at the community level
- Optimization of physical education classes at school sites
- Implementation of health promotion and care actions in the school context
- Development of skills in the school community for health care and generation of healthy school environments
- Creation and strengthening of health and nutrition committees in schools, with the participation of directors, teachers and parents to generate necessary and permanent conditions that favor healthy environments
To achieve a greater rapprochement with the population, qualitative instruments will also be implemented before the intervention, such as focus groups and in-depth interviews, which allow the identification of barriers and possible solutions to improve eating habits and promote physical activity in the population. Likewise, during the intermediate and final measurement phases, similar qualitative strategies will be applied to rescue successes and points for improvement of the intervention.
During the implementation of the strategies, meticulous monitoring of the localities will be carried out to identify significant changes that may affect the eating habits and physical activity in either of the two groups (intervention and control).
- Conditions
- Sedentary Behavior, Adipose Tissue, Child Obesity
- Being tested
- Participatory intervention
- Keywords
- Child Obesity, Exercise, Healthy Eating, Anthropometry
- Medical subject headings
- Sedentary Behavior, Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participatory interventionBehavioural
Also called Healthy diet, Physical activity, Nutrition literacy
Surveillance in compliance with the regulation of the sale of food in school buildings, according to official guidelines Training for the preparation of hygienic and healthy food for the personnel in charge of food sale Promotion of the consumption of simple water and healthy foods Reconditioning of the infrastructure for the consumption of simple water, free and healthy food, and the realization of physical activity Organization of events and support in the coordination of groups that promote physical activity at the community level Optimization of physical education classes at school sites Implementation of health promotion and care actions in the school context Development of skills in the school community for health care and generation of healthy school environments Creation and strengthening of health and nutrition committees in schools, with the participation of directors, teachers and parents to generate necessary and permanent conditions that favor healthy environments
| Study group | Role | What they receive |
|---|---|---|
| General Intervention | Experimental | The strategies will be implemented in the three intervention elementary schools. The schools were conveniently chosen for the size of the student population. In addition to having a sufficient population, it was important that the authorities of each school site agreed to participate. Receives: Behavioral: Participatory intervention |
| Subsample intervention | Experimental | A group will be randomly selected from each school grade from the intervention schools, and within each chosen group 12 children will be randomly selected per group (48 children in total per school). Receives: Behavioral: Participatory intervention |
| Control | No intervention | Three primary schools were selected from a close locality (Villa Corona, Jalisco). This was chosen because it is similar in relation to the social, economic, and geographical context to the locality of intervention. The schools were selected for the similarity in the size of the student population of the intervention schools. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child overweigth and obesity
Shift prevalence of children overweigth and obesity
Measured: 3 years
Secondary outcomes (6)
Daily stepcount
Change childrens daily average stepcount
Measured: 3 years
Physical fitness score
Change childrens physical fitness score measured by EUROFIT protocol
Measured: 3 years
Self-efficacy
Change in children's perceptions about their capability to change their eating behavior. (A self-administered validated questionnaire, Likert scale, points summary obtained)
Measured: 3 years
Attitudes
Change in negative or positive perceptions about target eating behaviors. (A self-administered validated questionnaire, Likert scale, points summary obtained)
Measured: 3 years
Intention to change
Change in short term intentions to adopt a desirable eating behavior. (A self-administered validated questionnaire, Likert scale, points summary obtained)
Measured: 3 years
Fruit and vegetable intake during school recess
Change in fruit and vegetable intake (g) during school recess. (Direct observation and weighted foods)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 May 2015
- Primary completion31 May 2018
- Study completion1 Nov 2018
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 Sedentary BehaviorStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Monitoring and evaluation of the impact of the intervention will be carried out through a community trial. There will be three schools in each study group (intervention and control). There will be three measurement periods: a baseline in the 2015-2016 school year, an intermediate measurement in the 2016-2017 school year, and a final measurement in the 2017-2018 school year. The measurement periods will have an estimated duration of two months. In the measurement periods, the body composition of the children from 1st to 4th grade will be obtained, and they will be followed up for two years; The dynamics of water and food consumption, physical activity, functional physical capacities, as well as availability and accessibility of food in schools will be identified. In addition, from a sub-sample of the study subjects, questionnaires on the frequency of food consumption, additional anthropometric measurements, and venous blood will be obtained to determine glucose and blood lipid levels.
- Masking
- None (open label)
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iberoamerican Institute of Sports Science and Human Movement
- Sponsor type
- University, hospital or other
- Collaborators
- University of Guadalajara, Mexican National Institute of Public Health, Instituto Tecnológico y de Estudios Superiores de Occidente
- Responsible party
- Principal investigator, Cesar Octavio Ramos Garcia, PhD, Iberoamerican Institute of Sports Science and Human Movement
- Investigators
- Laura Patricia Arellano Gomez, PhD, Principal investigator, Instituto Tecnologico y de Estudios Superiores de OccidenteClio Chavez Palencia, PhD, Principal investigator, University of GuadalajaraHector Ochoa Gonzalez, MSc, Study director, Instituto Tecnologico y de Estudios Superiores de OccidenteOscar Loreto Garibay, PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679246
- Sponsor's protocol ID
- IICDEM-ID-001-2015
- Acronym
- Acatlan
- Status last verified
- Dec 2020
- First submitted
- 28 Aug 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Valencia-Sosa E, Chavez-Palencia C, Romero-Velarde E, Larrosa-Haro A, Vasquez-Garibay EM, Ramos-Garcia CO. Neck circumference as an indicator of elevated central adiposity in children. Public Health Nutr. 2019 Jul;22(10):1755-1761. doi: 10.1017/S1368980019000454. Epub 2019 Apr 2.
PubMed 30935440Ramos García, C. O., Loreto Garibay, O., & Ochoa González, H. (2017). Diagnostic precision of the submandibular skinfold, minimum waist circumference and minimum waist to height ratio, as adipose overweight and obesity indicators in children. Nutricion Clinica y Dietetica Hospitalaria, 37(2). https://doi.org/10.12873/372cesarramos
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participatory Intervention to Improve Nutrition and Physical Activity in Schoolchildren From Acatlán de Juárez, Jalisco
- ClinicalTrials.gov ID
- NCT04679246
- Acronym / sponsor ID
- Acatlan / IICDEM-ID-001-2015
- Conditions
- Sedentary Behavior, Adipose Tissue, Child Obesity
- Keywords
- Child Obesity, Exercise, Healthy Eating, Anthropometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Iberoamerican Institute of Sports Science and Human MovementUniversity, hospital or other
- Collaborators
- University of Guadalajara, Mexican National Institute of Public Health, Instituto Tecnológico y de Estudios Superiores de Occidente
- Study start
- 1 May 2015 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 22 Dec 2020 (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.
This is a community project carried out jointly by the Technological Institute of Higher Studies of the West (ITESO), the University Center of Tonalá of the University of Guadalajara (CUTonalá) and the University Center of Health Sciences of the University of Guadalajara ( CUCS) with advice from the National Institute of Public Health (INSP), financed by the Tresmontes Lucchetti company and endorsed by the Jalisco Association of Nutritionists, AC (AJANUT). This project follows the provisions of the "National Strategy for the Prevention and Control of Overweight, Obesity and Diabetes" signed by the executive branch of the Federal Government. In particular, this project is inserted within the Public Health Strategy, in the strategic axis of Health Promotion and educational communication (while still having an impact on the axes of Epidemiological Surveillance and Prevention). In addition, it follows the agreement in which the general guidelines for the expenditure and distribution of food and beverages prepared and processed in the schools of the National Educational System were obtained, proposed by the Ministries of Health and Public Education. The aforementioned referrals are intended to protect and improve the health of Mexican children.
Detailed description
The project is a community trial that will last three years, which includes an intervention group and a control group of three schools each. Acatlán de Juárez has a total of 11 elementary schools.
The strategies will be implemented in collaboration with the authorities of the Acatlán de Juárez community, the school authorities, ITESO staff, CUTonalá, CUCS, and AJANUT. Key actors from both the school and community levels will be involved through the study to adapt the strategies socially and culturally to promote community project ownership. An initial study of the viability of the project and the current conditions of food and physical activity in school facilities will be carried out, as well as the perception of the community. The research team will design the contents and materials of the intervention taking into account the opinions and suggestions of the community and the results of the initial study. The schools of the control group will be chosen from the municipality of Villa Corona, Jalisco, which is similar to Acatlán de Juárez.
The strategies proposed for intervention by the research team, which will be agreed with the community, including the following:
- Surveillance in compliance with the regulation of the sale of food in school buildings, according to official guidelines
- Sensitization of children, parents, teachers (especially those in charge of the physical education class) and personnel in charge of the food supply (school cooperative), to improve acceptance and commitment to the regulation of the sale of food
- Training for the preparation of hygienic and healthy food for the personnel in charge of food sale
- Promotion of the consumption of simple water and healthy foods
- Rescue and promotion of the consumption of regional foods
- Reconditioning of the infrastructure for the consumption of simple water, free and healthy food, and the realization of physical activity
- Organization of events and support in the coordination of groups that promote physical activity at the community level
- Optimization of physical education classes at school sites
- Implementation of health promotion and care actions in the school context
- Development of skills in the school community for health care and generation of healthy school environments
- Creation and strengthening of health and nutrition committees in schools, with the participation of directors, teachers and parents to generate necessary and permanent conditions that favor healthy environments
To achieve a greater rapprochement with the population, qualitative instruments will also be implemented before the intervention, such as focus groups and in-depth interviews, which allow the identification of barriers and possible solutions to improve eating habits and promote physical activity in the population. Likewise, during the intermediate and final measurement phases, similar qualitative strategies will be applied to rescue successes and points for improvement of the intervention.
During the implementation of the strategies, meticulous monitoring of the localities will be carried out to identify significant changes that may affect the eating habits and physical activity in either of the two groups (intervention and control).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Monitoring and evaluation of the impact of the intervention will be carried out through a community trial. There will be three schools in each study group (intervention and control). There will be three measurement periods: a baseline in the 2015-2016 school year, an intermediate measurement in the 2016-2017 school year, and a final measurement in the 2017-2018 school year. The measurement periods will have an estimated duration of two months. In the measurement periods, the body composition of the children from 1st to 4th grade will be obtained, and they will be followed up for two years; The dynamics of water and food consumption, physical activity, functional physical capacities, as well as availability and accessibility of food in schools will be identified. In addition, from a sub-sample of the study subjects, questionnaires on the frequency of food consumption, additional anthropometric measurements, and venous blood will be obtained to determine glucose and blood lipid levels.
| Arm | Type | Receives |
|---|---|---|
| General Intervention | Experimental | Behavioral: Participatory interventionThe strategies will be implemented in the three intervention elementary schools. The schools were conveniently chosen for the size of the student population. In addition to having a sufficient population, it was important that the authorities of each school site agreed to participate. |
| Subsample intervention | Experimental | Behavioral: Participatory interventionA group will be randomly selected from each school grade from the intervention schools, and within each chosen group 12 children will be randomly selected per group (48 children in total per school). |
| Control | No intervention | –Three primary schools were selected from a close locality (Villa Corona, Jalisco). This was chosen because it is similar in relation to the social, economic, and geographical context to the locality of intervention. The schools were selected for the similarity in the size of the student population of the intervention schools. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children 6 to 10 years of age (completed at the beginning of the study) attending public schools.
- Mothers and fathers of school-age children.
- Responsible for cooperatives and school canteens.
- Key actors and members of the different groups involved in the implementation of the strategies.
Key exclusion criteria (5 listed)
- Chronic disease with a confirmed diagnosis (cancer, type 1 or type 2 diabetes).
- Physical limitations that could affect development and normal eating patterns.
- Use of medications that can influence energy consumption and expenditure (for example, antidepressant drugs, antipsychotics, steroids).
- Children who are or were in a weight reduction program in the last year.
- Use of medications or confirmed diagnosis of diseases that could alter laboratory values.
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 |
|---|---|---|
| Participatory interventionAlso: Healthy diet, Physical activity, Nutrition literacySurveillance in compliance with the regulation of the sale of food in school buildings, according to official guidelines Training for the preparation of hygienic and healthy food for the personnel in charge of food sale Promotion of the consumption of simple water and healthy foods Reconditioning of the infrastructure for the consumption of simple water, free and healthy food, and the realization of physical activity Organization of events and support in the coordination of groups that promote physical activity at the community level Optimization of physical education classes at school sites Implementation of health promotion and care actions in the school context Development of skills in the school community for health care and generation of healthy school environments Creation and strengthening of health and nutrition committees in schools, with the participation of directors, teachers and parents to generate necessary and permanent conditions that favor healthy environments | Behavioural | General Intervention, Subsample intervention |
Primary outcome
Child overweigth and obesity
Time frame: 3 years
Shift prevalence of children overweigth and obesity
6 secondary outcomes
Daily stepcount
Time frame: 3 years
Physical fitness score
Time frame: 3 years
Self-efficacy
Time frame: 3 years
Attitudes
Time frame: 3 years
Intention to change
Time frame: 3 years
Fruit and vegetable intake during school recess
Time frame: 3 years
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 22 Dec 2020.
- Results publication: PubMed 30935440Valencia-Sosa E, Chavez-Palencia C, Romero-Velarde E, Larrosa-Haro A, Vasquez-Garibay EM, Ramos-Garcia CO. Neck circumference as an indicator of elevated central adiposity in children. Public Health Nutr. 2019 Jul;22(10):1755-1761. doi: 10.1017/S1368980019000454. Epub 2019 Apr 2.
- Results publicationRamos García, C. O., Loreto Garibay, O., & Ochoa González, H. (2017). Diagnostic precision of the submandibular skinfold, minimum waist circumference and minimum waist to height ratio, as adipose overweight and obesity indicators in children. Nutricion Clinica y Dietetica Hospitalaria, 37(2). https://doi.org/10.12873/372cesarramos
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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.
Laura Patricia Arellano Gomez, PhD principal investigator
Instituto Tecnologico y de Estudios Superiores de Occidente
Clio Chavez Palencia, PhD principal investigator
University of Guadalajara
Hector Ochoa Gonzalez, MSc study director
Instituto Tecnologico y de Estudios Superiores de Occidente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participatory intervention in people with Sedentary Behavior and Adipose Tissue, run by Iberoamerican Institute of Sports Science and Human Movement 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 4 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 22 Dec 2020. 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?
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?
Child overweigth and obesity (time frame: 3 years). 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 NCT04679246, 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 22 Dec 2020.