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

NCT ID: NCT04095910

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-18
• Study Completion Date: 2019-09-13

Brief Summary

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.

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

Conditions

Childhood Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Planet Nutrition program

multidisciplinary school- based program

Group Type: EXPERIMENTAL

Planet Nutrition program

Intervention Type: BEHAVIORAL

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.

Control Group

Normal curricular classes

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Sonora

OTHER

Sponsor Role: lead

Responsible Party

Rolando Giovanni Díaz Zavala

Full time professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro de Promoción de Salud Nutricional (CPSN)

Hermosillo, Sonora, Mexico

Countries

Mexico

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Other Identifiers

PPN01

Identifier Type: -

Identifier Source: org_study_id