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Completed

NCT Number: NCT04095910

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

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.

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Key information

Conditions

Childhood Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Promoción de Salud Nutricional (CPSN)

Hermosillo, Sonora, 83000, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Planet Nutrition Program

Behavioral
  • - 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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Change in BMI Z score

    Time frame: 9 weeks to 21 weeks

    It will be measured returning from summer vacations, following the same method.

Sponsors and collaborators

Lead sponsor

Universidad de Sonora

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2019
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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