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

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Planet Nutrition program
Sponsored by
Universidad de Sonora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Prevention, Obesity, Childhood, School-based Program, Lifestyle, Nutrition Education

Eligibility Criteria

9 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Centro de Promoción de Salud Nutricional (CPSN)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Planet Nutrition program

Control Group

Arm Description

multidisciplinary school- based program

Normal curricular classes

Outcomes

Primary Outcome Measures

Change in BMI z score
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.

Secondary Outcome Measures

Change in body fat
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.
Change in waist circumference
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.
Change in the consumption of healthy and unhealthy food
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.
Change in auto-reported physical activity and sedentary activities
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.
Change in nutrition knowledge
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.
Change in systolic and diastolic blood pressure
A digital sphygmomanometer, model Omron HEM-907, was used. Two measurements were made to obtain an average value of systolic and diastolic blood pressure.
Change in cardiorespiratory capacity
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.
Change in BMI Z score
It will be measured returning from summer vacations, following the same method.

Full Information

First Posted
September 17, 2019
Last Updated
August 3, 2020
Sponsor
Universidad de Sonora
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1. Study Identification

Unique Protocol Identification Number
NCT04095910
Brief Title
Evaluation of the Planet Nutrition Program on Obesity Parameters in Mexican Schoolchildren
Official Title
Evaluation of the Planet Nutrition Program on Obesity Parameters in Mexican Schoolchildren: Pilot Randomized ControlledTrial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
June 7, 2019 (Actual)
Study Completion Date
September 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Sonora

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Prevention, Obesity, Childhood, School-based Program, Lifestyle, Nutrition Education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
None (open label)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Planet Nutrition program
Arm Type
Experimental
Arm Description
multidisciplinary school- based program
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Normal curricular classes
Intervention Type
Behavioral
Intervention Name(s)
Planet Nutrition program
Intervention Description
- 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. - 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. - Indirect family participation: Six information brochures with different nutrition and health topics were sent to parents.
Primary Outcome Measure Information:
Title
Change in BMI z score
Description
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.
Time Frame
Baseline to 9 weeks
Secondary Outcome Measure Information:
Title
Change in body fat
Description
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.
Time Frame
Baseline to 9 weeks
Title
Change in waist circumference
Description
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.
Time Frame
Baseline to 9 weeks
Title
Change in the consumption of healthy and unhealthy food
Description
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.
Time Frame
Baseline to 9 weeks
Title
Change in auto-reported physical activity and sedentary activities
Description
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.
Time Frame
Baseline to 9 weeks
Title
Change in nutrition knowledge
Description
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.
Time Frame
Baseline to 9 weeks
Title
Change in systolic and diastolic blood pressure
Description
A digital sphygmomanometer, model Omron HEM-907, was used. Two measurements were made to obtain an average value of systolic and diastolic blood pressure.
Time Frame
Baseline to 9 weeks
Title
Change in cardiorespiratory capacity
Description
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.
Time Frame
Baseline to 9 weeks
Title
Change in BMI Z score
Description
It will be measured returning from summer vacations, following the same method.
Time Frame
9 weeks to 21 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Centro de Promoción de Salud Nutricional (CPSN)
City
Hermosillo
State/Province
Sonora
ZIP/Postal Code
83000
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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29029897
Citation
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Evaluation of the Planet Nutrition Program on Obesity Parameters in Mexican Schoolchildren

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