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

Childhood Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04095910
• Other study ID #: PPN01
• Status: Completed
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: September 13, 2019

Study information

• Verified date: August 2020
• Source: Universidad de Sonora
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 13, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Planet Nutrition program
- 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.

Locations

Country	Name	City	State
Mexico	Centro de Promoción de Salud Nutricional (CPSN)	Hermosillo	Sonora

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Sonora

Country where clinical trial is conducted

Mexico, 

References & Publications (11)

Brown T, Moore TH, Hooper L, Gao Y, Zayegh A, Ijaz S, Elwenspoek M, Foxen SC, Magee L, O'Malley C, Waters E, Summerbell CD. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2019 Jul 23;7:CD001871. doi: 10.1002/14651858.CD001871.pub4. — View Citation

Currie C, Griebler R, Inchley J, Theunissen A, Molcho M, Samdal O, Dür W. 2010. Health Behaviour in School-aged Children (HBSC) Study Protocol: Background, Methodology and Mandatory items for the 2009/10 Survey. Edinburgh: CHRU & Vienna: LBIHPR.

Díaz-Zavala RG, Castro-Cantú MF, Valencia ME, Álvarez-Hernández G, Haby MM, Esparza-Romero J. Effect of the Holiday Season on Weight Gain: A Narrative Review. J Obes. 2017;2017:2085136. doi: 10.1155/2017/2085136. Epub 2017 Jul 4. Review. — View Citation

Flynn JT, Kaelber DC, Baker-Smith CM, et al; SUBCOMMITTEE ON SCREENING AND MANAGEMENT OF HIGH BLOOD PRESSURE IN CHILDREN. Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents. Pediatrics. 2017; 140(3):e20171904. Pediatrics. 2017 Dec;140(6). pii: e20173035. doi: 10.1542/peds.2017-3035. — View Citation

Franckle R, Adler R, Davison K. Accelerated weight gain among children during summer versus school year and related racial/ethnic disparities: a systematic review. Prev Chronic Dis. 2014 Jun 12;11:E101. doi: 10.5888/pcd11.130355. Review. — View Citation

Gortmaker SL, Peterson K, Wiecha J, Sobol AM, Dixit S, Fox MK, Laird N. Reducing obesity via a school-based interdisciplinary intervention among youth: Planet Health. Arch Pediatr Adolesc Med. 1999 Apr;153(4):409-18. — View Citation

Léger LA, Mercier D, Gadoury C, Lambert J. The multistage 20 metre shuttle run test for aerobic fitness. J Sports Sci. 1988 Summer;6(2):93-101. — View Citation

NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in body-mass index, underweight, overweight, and obesity from 1975 to 2016: a pooled analysis of 2416 population-based measurement studies in 128·9 million children, adolescents, and adults. Lancet. 2017 Dec 16;390(10113):2627-2642. doi: 10.1016/S0140-6736(17)32129-3. Epub 2017 Oct 10. — View Citation

Ramírez E, Valencia ME, Bourges H, Espinosa T, Moya-Camarena SY, Salazar G, Alemán-Mateo H. Body composition prediction equations based on deuterium oxide dilution method in Mexican children: a national study. Eur J Clin Nutr. 2012 Oct;66(10):1099-103. doi: 10.1038/ejcn.2012.89. Epub 2012 Jul 18. — View Citation

Shamah Levy T, Morales Ruán C, Amaya Castellanos C, Salazar Coronel A, Jiménez Aguilar A, Méndez Gómez Humarán I. Effectiveness of a diet and physical activity promotion strategy on the prevention of obesity in Mexican school children. BMC Public Health. 2012 Mar 1;12:152. doi: 10.1186/1471-2458-12-152. — View Citation

WHO. 2007. Growth Reference 5-19 years. BMI-for-age (5-19 years). https://www.who.int/growthref/en/

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 9 weeks
Secondary	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.	Baseline to 9 weeks
Secondary	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.	Baseline to 9 weeks
Secondary	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.	Baseline to 9 weeks
Secondary	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.	Baseline to 9 weeks
Secondary	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.	Baseline to 9 weeks
Secondary	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.	Baseline to 9 weeks
Secondary	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.	Baseline to 9 weeks
Secondary	Change in BMI Z score	It will be measured returning from summer vacations, following the same method.	9 weeks to 21 weeks