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Clinical Trials/NCT04095910
NCT04095910
Completed
N/A

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

Universidad de Sonora1 site in 1 country41 target enrollmentMarch 18, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Childhood Obesity
Sponsor
Universidad de Sonora
Enrollment
41
Locations
1
Primary Endpoint
Change in BMI z score
Status
Completed
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 18, 2019
End Date
September 13, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rolando Giovanni Díaz Zavala

Full time professor

Universidad de Sonora

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.

Outcomes

Primary Outcomes

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

  • Change in the consumption of healthy and unhealthy food(Baseline to 9 weeks)
  • Change in nutrition knowledge(Baseline to 9 weeks)
  • Change in systolic and diastolic blood pressure(Baseline to 9 weeks)
  • Change in auto-reported physical activity and sedentary activities(Baseline to 9 weeks)
  • Change in body fat(Baseline to 9 weeks)
  • Change in waist circumference(Baseline to 9 weeks)
  • Change in cardiorespiratory capacity(Baseline to 9 weeks)
  • Change in BMI Z score(9 weeks to 21 weeks)

Study Sites (1)

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