ObesityNCT03768245
School-Based Program On Metabolic Disease
A study testing Health Education and Physical activity program and Nutrition Program in people with Obesity and Diabetes Mellitus, Type 2, run by Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado at 1 site in Mexico.
Trial summary
Mexico occupies the first place worldwide in childhood obesity. Its urban and indigenous communities present different levels of westernization which have triggered different epidemiological diseases. This study aims to treat and prevent obesity and related diseases. Read more about this study
- Who is it for?
- Ages 4 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2, Cardiovascular Function
- What is being tested?
- Health Education and Physical activity program and Nutrition Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jul 2016to 30 Nov 2016
- 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 4 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children from the selected grades and schools.
- Children who voluntarily accept participating in the program.
- Children whose parents must authorize their participation in the program, signing an informed consent document.
Who cannot join
- Participants with any incapacity to perform physical activity.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Regional Adolfo Lopez Matelos
Mexico City, Mexico City, 01620
About this study
Official title: Multi-Component School-Based Program On Obesity and Related Diseases, In A Multi-Ethnic Study
Mexico occupies the first place worldwide in childhood obesity. Its urban and indigenous communities present different levels of westernization which have triggered different epidemiological diseases. This study aims to treat and prevent obesity and related diseases. A school-based multi-component intervention program is developed in three ethnic groups with varying levels of westernization: Mestizos, Seris and Yaquis. Measurements are obtained to evaluate obesity, cardiovascular, diabetes risk, hepatic and renal function, and physical fitness. The intervention consists on Physical Activity (PA), Health Education (HE) and Nutrition (NP) programs carried out in six urban (Mestizo ethnic group) and indigenous schools (Seri and Yaqui ethnic groups). A total of 800 participants were part of the PA and HE programs (Education Arm), and 117 of them were also part of the NP program (Nutrition Arm). Measurement differences, after and before treatments are used to assess the intervention effect by age, sex, ethnicity, nutritional status, and treatments. Expanded access is not applicable to this study. The Government's Secretary of Education does not allow developing a plan to share individual data of participants.
Read the detailed description
Participants from one preschool and 5 primary schools are included in the study. Participants are children between 5 and 12 years old from Sonora State, North of Mexico. Four urban schools of Mexican-Mestizos (from Hermosillo, capital city) and two indigenous schools, Seris (from Punta Chueca) and Yaquis (from Bahía de Lobos), participate in the program. Urban schools are randomly selected. Indigenous schools are hard to access, thus Seris and Yaquis school are chosen based on higher accessibility, and all grades from those schools (from first to sixth) are included. The intervention program consists of implementing Health Education, Nutrition and Physical Activity programs, and also parent involvement activities. All nutritionists, psychologists, and physical education teachers are prepared for their lessons during two weeks before the project implementation by the developers of the project (PCU and RA), who also supervise them. The intervention program is split into two Arms; the Education Arm, which is applied to all participants, and the Nutrition Arm, which includes the Health Education, the Physical Activity and also the Nutrition programs. The Nutrition program is randomly applied just in the Mestizo group, i.e. schools and grade are randomly allocated in Nutrition program. Anthropogenic and biochemical measurements are collected before (Measurements 1, M1) and after (Measurements 2, M2) treatments. Anthropogenic measurements are taken to all participants, while biochemical are randomly taken to 320 participants (includes all form Nutrition Arm). M1 and M2 are taken by the same team. Intervention effect is measured as the difference between M2 and M1, calculated as the difference (Dif) in M=M2-M1. Thus, negative DifM values indicate a decrease in the variable measured after the intervention, while positive DifM values indicate an increase in the variable. To assess the effect of age, sex, ethnic group (Mestizos, Seris, Yaquis), treatments (T1, T2) and nutritional status (Normal weight, Overweight+Obesity) in DifM (i.e. DifBMI), we perform Generalized Linear Models (GLMs) with Gaussian distribution(1). The initial model contains all single effects and all possible interactions of such explanatory variables. GLM simplification is done by stepwise deletion of the least significant terms. Subsequent models were generated by the stepwise removal of non-significant terms, and assessing each simplification with the Akaike information criterion (AIC) using the ΔAIC > 2 criterion(2). All models considered are subjected to the customary residual analyses and show a satisfactory fit (results not shown). All statistical analyses are carried out in R(3).
- Conditions
- Obesity, Diabetes Mellitus, Type 2, Cardiovascular Function, Kidney Diseases, Liver Diseases, Physical Fitness
- Being tested
- Health Education and Physical activity program, Nutrition Program
- Keywords
- Body Mass Index, Glucose, Haemoglobin glycosylated, Blood Lipids, Liver Function, Kidney Function, Exercise, Physical activity
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Kidney Diseases, Liver Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Education and Physical activity programBehavioural
Its objective is to empower children on healthy lifestyle, addressing four main topics: nutrition (i.e. healthy food, hydration), adequate quantities of food, physical activity, and self-monitoring. The program is implemented in the classroom through workshops planned and conducted by psychologists and nutritionists. A total of 12 workshops are planned, to be conducted once a week, and lasting 50 minutes each. The Physical activity program objective is to develop an active scholar environment, and consists of a moderate-vigorous activity, five days a week. The activities are divided into two types: (a) in the school backyard for 60 minutes, three times a week, and (b) in the classroom two days a week, for 15 minutes three times a day, adding up to 45 minutes daily.
Nutrition ProgramDietary supplement
Its objective is to maintain lean mass, decrease fat mass and ensure mineral vitamins and fatty acids intake, maintain proper growth under National Specific Action Program: Food and Activity4. From total energy, a fat intake of 25-35%, carbohydrate intake of 45-65%, protein intake of 10-30%, and total calories are adjusted according to age. The Nutrition program consists of three meals: breakfast, a snack for a mid-morning playtime, and lunch at school. Food is prepared daily following sanitary and quality standards of Mexican official regulation. Breakfast is served 40 minutes before starting class time, lunch is served 40 minutes before leaving school.
| Study group | Role | What they receive |
|---|---|---|
| Behaviour | Experimental | Physical activity and the Health Education programs are applied. Receives: Behavioral: Health Education and Physical activity program |
| Nutrition | Active comparator | In this Arm, the the Physical activity, the Health education and Nutrition program are applied. Receives: Behavioral: Health Education and Physical activity program; Dietary Supplement: Nutrition Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline In Body Mass Index At 12 Weeks
Weight is measured kilograms using a Seca scale. Height is measured in meters cm using a standardized portable stadiometer Microtoise. Weight and height are be combined to report Body mass index (BMI) in kg/m^2. BMI cut-off points of normal weight, overweight and obesity are used as defined by World Health Organization5.
Measured: Up to 12 weeks
Mean Change From Baseline In Fasting Glucose Profile At 12 Weeks
Blood samples are taken in the morning, after a 10-hours fasting to measure glucose in milligrams/decilitres.
Measured: Up to 12 weeks
Mean Change From Baseline In Fasting Glycated Haemoglobin At 12 Weeks
Blood samples are taken in the morning, after a 10-hours fasting to glycated haemoglobin in percentage.
Measured: Up to 12 weeks
Mean Change From Baseline In Fasting Triglycerides At 12 Weeks
Blood samples are taken in the morning, after a 10-hours fasting to triglycerides in milligrams/decilitres.
Measured: Up to 12 weeks
Mean Change From Baseline In Fasting Total Cholesterol At 12 Weeks
Blood samples are taken in the morning, after a 10-hours fasting to total cholesterol in milligrams/decilitres.
Measured: Up to 12 weeks
Mean Change From Baseline In Fasting High Density Lipoprotein Cholesterol At 12 Weeks
Blood samples are taken in the morning, after a 10-hours fasting to high density lipoprotein cholesterol in milligrams/decilitres.
Measured: Up to 12 weeks
Mean Change From Baseline In Fasting Low Density Lipoproteins Cholesterol At 12 Weeks
Blood samples are taken in the morning, after a 10-hours fasting to low density lipoprotein cholesterol in milligrams/decilitres.
Measured: Up to 12 weeks
Mean Change From Baseline In Fasting Creatinine At 12 Weeks
Description Blood samples were taken in the morning, after a 10-hours fasting to measure creatinine in milligrams/decilitres.
Measured: Up to 12 weeks
Mean Change From Baseline In Fasting Urea At 12 Weeks
Description Blood samples were taken in the morning, after a 10-hours fasting to measure urea in milligrams/decilitres.
Measured: Up to 12 weeks
Mean Change From Baseline In Fasting Urea Nitrogen At 12 Weeks
Blood samples were taken in the morning, after a 10-hours fasting to measure urea in milligrams/decilitres.
Measured: Up to 12 weeks
Mean Change From Baseline In Fasting Uric Acid At 12 Weeks
Description Blood samples were taken in the morning, after a 10-hours fasting to measure uric acid in milligrams/decilitres.
Measured: Up to 12 weeks
Mean Change From Baseline In Fasting Glutamic Oxalacetic Transaminase At 12 Weeks.
Blood samples were taken in the morning, after a 10-hour fast to measure glutamic oxalacetic transaminase measured in international units/litre (U/L).
Measured: Up to 12 weeks
Mean Change From Baseline In Fasting Glutamic Pyruvic Transaminase, At 12 Weeks
Blood samples were taken in the morning, after a 10-hour fast to measure glutamic pyruvic transaminase measured in international units/litre (U/L).
Measured: Up to 12 weeks
Mean Change From Baseline In Fasting Bilirubin Profile, At 12 Weeks
Blood samples were taken in the morning, after a 10-hour fast to measure direct, total and indirect bilirubin, measured in milligrams/decilitres.
Measured: Up to 12 weeks
Mean Change From Baseline In Indirect Of Maximum Oxygen Consumption At 12 Weeks
The Course-Navette test are used to measure the indirect maximum oxygen consumption measured in milligrams/kilograms/minutes.
Measured: Up to 12 weeks
Mean Change From Baseline In Speed At 12 Weeks
Speed is measured in meters/seconds using the 4x10 meters test.
Measured: Up to 12 weeks
Mean Change From Baseline In Strength-Resistance At 12 Weeks
Strength-resistance is measured in number of repetition using the abdominal strength test, which consists of recording the maximum number of abdominals in 30 seconds.
Measured: Up to 12 weeks
Mean Change From Baseline In Power At 12 Weeks
Power is measured in centimetres, using the long jump test which measures the explosive power of the lower body, and the vertical jump test, measured in centimetres, for measuring changes in leg power.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Jul 2016
- Primary completion15 Sep 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention program is split into two groups of participants which receive two deferments treatments (Arms); treatment (Arm 1) is applied to all participants (n=800), while treatment 2 (Arm 2) is randomly applied just in the Mestizo group (n=117), i.e. schools and grade are randomly allocated in Arm 2
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Paula Costa Urrutia, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
- Investigators
- Paula Costa-Urrutia, Ph.D, Study director, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768245
- Sponsor's protocol ID
- 433.2016
- Status last verified
- Dec 2018
- First submitted
- 4 Dec 2018
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Costa-Urrutia P, Alvarez-Farina R, Abud C, Franco-Trecu V, Esparza-Romero J, Lopez-Morales CM, Rodriguez-Arellano ME, Valle Leal J, Colistro V, Granados J. Effect of multi-component school-based program on body mass index, cardiovascular and diabetes risks in a multi-ethnic study. BMC Pediatr. 2019 Nov 4;19(1):401. doi: 10.1186/s12887-019-1787-x.
PubMed 31679507
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Component School-Based Program On Obesity and Related Diseases, In A Multi-Ethnic Study
- ClinicalTrials.gov ID
- NCT03768245
- Acronym / sponsor ID
- 433.2016
- Conditions
- Obesity, Diabetes Mellitus, Type 2, Cardiovascular Function, Kidney Diseases, Liver Diseases, Physical Fitness
- Keywords
- Body Mass Index, Glucose, Haemoglobin glycosylated, Blood Lipids, Liver Function, Kidney Function, Exercise, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del EstadoOther government
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 15 Sep 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 7 Dec 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.
Mexico occupies the first place worldwide in childhood obesity. Its urban and indigenous communities present different levels of westernization which have triggered different epidemiological diseases. This study aims to treat and prevent obesity and related diseases. A school-based multi-component intervention program is developed in three ethnic groups with varying levels of westernization: Mestizos, Seris and Yaquis. Measurements are obtained to evaluate obesity, cardiovascular, diabetes risk, hepatic and renal function, and physical fitness. The intervention consists on Physical Activity (PA), Health Education (HE) and Nutrition (NP) programs carried out in six urban (Mestizo ethnic group) and indigenous schools (Seri and Yaqui ethnic groups). A total of 800 participants were part of the PA and HE programs (Education Arm), and 117 of them were also part of the NP program (Nutrition Arm). Measurement differences, after and before treatments are used to assess the intervention effect by age, sex, ethnicity, nutritional status, and treatments. Expanded access is not applicable to this study. The Government's Secretary of Education does not allow developing a plan to share individual data of participants.
Detailed description
Participants from one preschool and 5 primary schools are included in the study. Participants are children between 5 and 12 years old from Sonora State, North of Mexico. Four urban schools of Mexican-Mestizos (from Hermosillo, capital city) and two indigenous schools, Seris (from Punta Chueca) and Yaquis (from Bahía de Lobos), participate in the program. Urban schools are randomly selected. Indigenous schools are hard to access, thus Seris and Yaquis school are chosen based on higher accessibility, and all grades from those schools (from first to sixth) are included. The intervention program consists of implementing Health Education, Nutrition and Physical Activity programs, and also parent involvement activities. All nutritionists, psychologists, and physical education teachers are prepared for their lessons during two weeks before the project implementation by the developers of the project (PCU and RA), who also supervise them. The intervention program is split into two Arms; the Education Arm, which is applied to all participants, and the Nutrition Arm, which includes the Health Education, the Physical Activity and also the Nutrition programs. The Nutrition program is randomly applied just in the Mestizo group, i.e. schools and grade are randomly allocated in Nutrition program. Anthropogenic and biochemical measurements are collected before (Measurements 1, M1) and after (Measurements 2, M2) treatments. Anthropogenic measurements are taken to all participants, while biochemical are randomly taken to 320 participants (includes all form Nutrition Arm). M1 and M2 are taken by the same team. Intervention effect is measured as the difference between M2 and M1, calculated as the difference (Dif) in M=M2-M1. Thus, negative DifM values indicate a decrease in the variable measured after the intervention, while positive DifM values indicate an increase in the variable. To assess the effect of age, sex, ethnic group (Mestizos, Seris, Yaquis), treatments (T1, T2) and nutritional status (Normal weight, Overweight+Obesity) in DifM (i.e. DifBMI), we perform Generalized Linear Models (GLMs) with Gaussian distribution(1). The initial model contains all single effects and all possible interactions of such explanatory variables. GLM simplification is done by stepwise deletion of the least significant terms. Subsequent models were generated by the stepwise removal of non-significant terms, and assessing each simplification with the Akaike information criterion (AIC) using the ΔAIC > 2 criterion(2). All models considered are subjected to the customary residual analyses and show a satisfactory fit (results not shown). All statistical analyses are carried out in R(3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention program is split into two groups of participants which receive two deferments treatments (Arms); treatment (Arm 1) is applied to all participants (n=800), while treatment 2 (Arm 2) is randomly applied just in the Mestizo group (n=117), i.e. schools and grade are randomly allocated in Arm 2
| Arm | Type | Receives |
|---|---|---|
| Behaviour | Experimental | Behavioral: Health Education and Physical activity programPhysical activity and the Health Education programs are applied. |
| Nutrition | Active comparator | Behavioral: Health Education and Physical activity program, Dietary Supplement: Nutrition ProgramIn this Arm, the the Physical activity, the Health education and Nutrition program are applied. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children from the selected grades and schools.
- Children who voluntarily accept participating in the program.
- Children whose parents must authorize their participation in the program, signing an informed consent document.
Key exclusion criteria (1 listed)
- Participants with any incapacity to perform physical activity.
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 |
|---|---|---|
| Health Education and Physical activity programIts objective is to empower children on healthy lifestyle, addressing four main topics: nutrition (i.e. healthy food, hydration), adequate quantities of food, physical activity, and self-monitoring. The program is implemented in the classroom through workshops planned and conducted by psychologists and nutritionists. A total of 12 workshops are planned, to be conducted once a week, and lasting 50 minutes each. The Physical activity program objective is to develop an active scholar environment, and consists of a moderate-vigorous activity, five days a week. The activities are divided into two types: (a) in the school backyard for 60 minutes, three times a week, and (b) in the classroom two days a week, for 15 minutes three times a day, adding up to 45 minutes daily. | Behavioural | Behaviour, Nutrition |
| Nutrition ProgramIts objective is to maintain lean mass, decrease fat mass and ensure mineral vitamins and fatty acids intake, maintain proper growth under National Specific Action Program: Food and Activity4. From total energy, a fat intake of 25-35%, carbohydrate intake of 45-65%, protein intake of 10-30%, and total calories are adjusted according to age. The Nutrition program consists of three meals: breakfast, a snack for a mid-morning playtime, and lunch at school. Food is prepared daily following sanitary and quality standards of Mexican official regulation. Breakfast is served 40 minutes before starting class time, lunch is served 40 minutes before leaving school. | Dietary supplement | Nutrition |
Primary outcome
Mean Change From Baseline In Body Mass Index At 12 Weeks
Time frame: Up to 12 weeks
Weight is measured kilograms using a Seca scale. Height is measured in meters cm using a standardized portable stadiometer Microtoise. Weight and height are be combined to report Body mass index (BMI) in kg/m^2. BMI cut-off points of normal weight, overweight and obesity are used as defined by World Health Organization5.
Mean Change From Baseline In Fasting Glucose Profile At 12 Weeks
Time frame: Up to 12 weeks
Blood samples are taken in the morning, after a 10-hours fasting to measure glucose in milligrams/decilitres.
Mean Change From Baseline In Fasting Glycated Haemoglobin At 12 Weeks
Time frame: Up to 12 weeks
Blood samples are taken in the morning, after a 10-hours fasting to glycated haemoglobin in percentage.
Mean Change From Baseline In Fasting Triglycerides At 12 Weeks
Time frame: Up to 12 weeks
Blood samples are taken in the morning, after a 10-hours fasting to triglycerides in milligrams/decilitres.
Mean Change From Baseline In Fasting Total Cholesterol At 12 Weeks
Time frame: Up to 12 weeks
Blood samples are taken in the morning, after a 10-hours fasting to total cholesterol in milligrams/decilitres.
Mean Change From Baseline In Fasting High Density Lipoprotein Cholesterol At 12 Weeks
Time frame: Up to 12 weeks
Blood samples are taken in the morning, after a 10-hours fasting to high density lipoprotein cholesterol in milligrams/decilitres.
Mean Change From Baseline In Fasting Low Density Lipoproteins Cholesterol At 12 Weeks
Time frame: Up to 12 weeks
Blood samples are taken in the morning, after a 10-hours fasting to low density lipoprotein cholesterol in milligrams/decilitres.
Mean Change From Baseline In Fasting Creatinine At 12 Weeks
Time frame: Up to 12 weeks
Description Blood samples were taken in the morning, after a 10-hours fasting to measure creatinine in milligrams/decilitres.
Mean Change From Baseline In Fasting Urea At 12 Weeks
Time frame: Up to 12 weeks
Description Blood samples were taken in the morning, after a 10-hours fasting to measure urea in milligrams/decilitres.
Mean Change From Baseline In Fasting Urea Nitrogen At 12 Weeks
Time frame: Up to 12 weeks
Blood samples were taken in the morning, after a 10-hours fasting to measure urea in milligrams/decilitres.
Mean Change From Baseline In Fasting Uric Acid At 12 Weeks
Time frame: Up to 12 weeks
Description Blood samples were taken in the morning, after a 10-hours fasting to measure uric acid in milligrams/decilitres.
Mean Change From Baseline In Fasting Glutamic Oxalacetic Transaminase At 12 Weeks.
Time frame: Up to 12 weeks
Blood samples were taken in the morning, after a 10-hour fast to measure glutamic oxalacetic transaminase measured in international units/litre (U/L).
Mean Change From Baseline In Fasting Glutamic Pyruvic Transaminase, At 12 Weeks
Time frame: Up to 12 weeks
Blood samples were taken in the morning, after a 10-hour fast to measure glutamic pyruvic transaminase measured in international units/litre (U/L).
Mean Change From Baseline In Fasting Bilirubin Profile, At 12 Weeks
Time frame: Up to 12 weeks
Blood samples were taken in the morning, after a 10-hour fast to measure direct, total and indirect bilirubin, measured in milligrams/decilitres.
Mean Change From Baseline In Indirect Of Maximum Oxygen Consumption At 12 Weeks
Time frame: Up to 12 weeks
The Course-Navette test are used to measure the indirect maximum oxygen consumption measured in milligrams/kilograms/minutes.
Mean Change From Baseline In Speed At 12 Weeks
Time frame: Up to 12 weeks
Speed is measured in meters/seconds using the 4x10 meters test.
Mean Change From Baseline In Strength-Resistance At 12 Weeks
Time frame: Up to 12 weeks
Strength-resistance is measured in number of repetition using the abdominal strength test, which consists of recording the maximum number of abdominals in 30 seconds.
Mean Change From Baseline In Power At 12 Weeks
Time frame: Up to 12 weeks
Power is measured in centimetres, using the long jump test which measures the explosive power of the lower body, and the vertical jump test, measured in centimetres, for measuring changes in leg power.
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 7 Dec 2018.
- Derived from this study: PubMed 31679507Costa-Urrutia P, Alvarez-Farina R, Abud C, Franco-Trecu V, Esparza-Romero J, Lopez-Morales CM, Rodriguez-Arellano ME, Valle Leal J, Colistro V, Granados J. Effect of multi-component school-based program on body mass index, cardiovascular and diabetes risks in a multi-ethnic study. BMC Pediatr. 2019 Nov 4;19(1):401. doi: 10.1186/s12887-019-1787-x.
- Describe the tests for physical fitness evaluationLink 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.
Paula Costa-Urrutia, Ph.D study director
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education and Physical activity program and Nutrition Program in people with Obesity and Diabetes Mellitus, Type 2, run by Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado 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 3 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: finished, as of the sponsor's last update on 7 Dec 2018. 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?
Mean Change From Baseline In Body Mass Index At 12 Weeks (time frame: Up to 12 weeks). The study lists 18 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 NCT03768245, which also lists 1 linked publication.
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 7 Dec 2018.