Evaluation of the Planet Nutrition Program on Obesity Parameters in Mexican Schoolchildren

August 3, 2020 updated by: Rolando Giovanni Díaz Zavala, Universidad de Sonora

Evaluation of the Planet Nutrition Program on Obesity Parameters in Mexican Schoolchildren: Pilot Randomized ControlledTrial

Obesity prevention programs in schools are essential to promoting healthy lifestyles. There are programs with positive effects on obesity parameters, but only a few of them have didactic material for its dissemination. In United States they have effective programs (with materials for their implementation) and some are already being implemented in different schools. In Mexico our study group has developed a program called "Planet Nutrition" that includes a manual.The main aim of this study is to evaluate the efficacy of the program "Planet Nutrition"-a nutrition education and behaviour change program- on BMI Z score in school children compared to a control group at 9 weeks. This pilot stud is a randomized controlled trial. The study will be conducted with 41 participants. The primary outcome was the change in the BMI Z score from baseline to 9 weeks. Secondary outcomes were the changes from baseline to 9 weeks in body fat percentage, waist circumference, systolic and diastolic blood pressure, consumption of healthy and unhealthy food, physical activity and sedentary lifestyle, cardiorespiratory capacity and nutrition knowledge. Additionally BMI Z score will be measured at 23 weeks, after the summer vacations. Considering evidence that this period could have a negative impact on children´s weight.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Fifth grade students from a public elementary school in Hermosillo, Sonora, Mexico were invited to participate in the program. The nutritionist team of the study made the request face to face in the classrooms. A printed invitation was delivered to be given to schoolchildren parents, in addition to the informed consent and assent along with a data questionnaire. To be included children must be in fifth grade from the chosen school and be between 9 to 12 years old. The exclusion criteria were, having or develop a medical condition, taking medication or having an intervention that affects body weight, having a condition that prevents physical activity (cardiovascular, respiratory, muscular, osteoarticular, etc.) at baseline or during the study, and withdrawal of the consent informed

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Sonora
      • Hermosillo, Sonora, Mexico, 83000
        • Centro de Promoción de Salud Nutricional (CPSN)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fifth grade students of the chosen school.
  • Having 9 to 12 years old.

Exclusion Criteria:

  • Having a condition, taking medication or carrying out an intervention that affects body weight.
  • Condition that impede physical activity including cardiovascular, respiratory, muscular and bone condition.
  • Withdrawal of informed consent and assent.
  • Development of a health problem or taking medication with effect on body weight during the study.
  • Participate in another intervention or treatment for obesity management during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Planet Nutrition program
multidisciplinary school- based program
Behavioral: Planet Nutrition program
  1. - Nutritional education sessions: The study team previously worked on the development of a handbook called "Planet Nutrition" which contains around 26 topics of nutrition and health. Interns from the Nutritional Sciences Degree of the University of Sonora implemented the sessions. 2 classes of 1 hour were given weekly, adding 18 sessions in total, during regular school hours. The program contemplates the establishment of different objectives.
  2. - Physical activity: The classes were designed and implemented by interns from the Bachelor of Physical Culture and Sport from the University of Sonora along with a teacher from the study team. 3 weekly sessions of 1 hour were provided. The activities were held on the schoolyard court during normal school hours, independent of the physical activity classes of the school.
  3. - Indirect family participation: Six information brochures with different nutrition and health topics were sent to parents.
NO_INTERVENTION: Control Group
Normal curricular classes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in BMI z score
Time Frame: Baseline to 9 weeks
First, the weight and height of the children were measured with a SECA digital scale and a stadiometer (SECA 213). Then, the BMI z score was obtained using the WHO Anthro Plus software, where the values of weight, age, date of birth and sex were considered.
Baseline to 9 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in body fat
Time Frame: Baseline to 9 weeks
A tetrapolar electrical bioimpedance method (BIE) was used to obtain the resistance and reactance values. The measurement was made with the BIE team, RJL Quantum II. To estimate the body fat percentage, a validated equation in Mexican children was used.
Baseline to 9 weeks
Change in waist circumference
Time Frame: Baseline to 9 weeks
The measurement was taken at the umbilical scar level, with the participant standing and on the upper garment (due to the lack of privacy) using a non-stretch tape measure.
Baseline to 9 weeks
Change in the consumption of healthy and unhealthy food
Time Frame: Baseline to 9 weeks
The questionnaire consists of 12 questions about the consumption of healthy foods (fruits, vegetables, cereals, legumes, animal source food, dairy, etc.) and unhealthy (sugary drinks, salty snacks, sweets, pastries, sausages, etc..). The frequency ranges from never to more than twice a day.
Baseline to 9 weeks
Change in auto-reported physical activity and sedentary activities
Time Frame: Baseline to 9 weeks
It was measured by a validated questionnarie for schoolchildren which includes nine questions about the frequency and time spent in physical activity and sedentary activities during the week and weekend.
Baseline to 9 weeks
Change in nutrition knowledge
Time Frame: Baseline to 9 weeks
To assess the learning in the nutritional education sessions, a questionnaire designed by the study team was used. It consisted of 32 questions about nutrition and health. The answers consisted by multiple choice with 4 subsections (A-D) and true or false choices.
Baseline to 9 weeks
Change in systolic and diastolic blood pressure
Time Frame: Baseline to 9 weeks
A digital sphygmomanometer, model Omron HEM-907, was used. Two measurements were made to obtain an average value of systolic and diastolic blood pressure.
Baseline to 9 weeks
Change in cardiorespiratory capacity
Time Frame: Baseline to 9 weeks
It was measured by the Course Navette test to estimate the maxium oxygen consumption (Vo2 Max).The participants traveled a distance of 20 meters round trips, at the rhythm of a recording sound. The test is in one minute stages and the speed increases (0.85 km / h to 0.5 km / h). The participants were stopping when they felt tired. The test was carried out by the physical activity team of the study.
Baseline to 9 weeks
Change in BMI Z score
Time Frame: 9 weeks to 21 weeks
It will be measured returning from summer vacations, following the same method.
9 weeks to 21 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Sonora

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 18, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 7, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 13, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PPN01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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