Pediatric ObesityNCT05461703
Efficacy of a School-based Obesity Prevention Program in Mexican Schoolchildren: Cluster Randomized Controlled Trial
A study testing Planet Nutrition Program in people with Pediatric Obesity, run by Universidad de Sonora at 1 site in Mexico.
Trial summary
There is evidence that obesity prevention programs show positive effects on obesity and lifestyle parameters. However, the effect of the programs delivered by different implementers is unknown, and in Mexico, the available studies present methodological limitations. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Planet Nutrition Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteMexico
- Study dates
- 5 Dec 2022to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Schools:
- school directors and teachers wish to participate.
- availability of space for physical activity classes.
- the school has at least 20 children per 4th-grade group.
- Schoolchildren:
- -be a 4th grade student (9 to 11 years old).
Show all 9Show fewer
- Implemeters:
- receive 80% of the program training.
- respond satisfactorily to a questionnaire that tests knowledge of the program
Who cannot join
- Schools: participating in another similar study.
- Schoolchildren: Having a personal condition that prevents physical activity or a condition that parents consider should not involve the child.
Trial locations and contacts
1 site in 1 country.
Diana L Ramírez Rivera, MSc contact
About this study
Official title: "Efficacy of a School-based Obesity Prevention Program Delivery by Nutrition and Physical Activity Advanced Students or School Teachers on the BMI Z-score and Body Fat at 6 Months of Mexican Children: a Cluster Randomized Controlled Trial"
There is evidence that obesity prevention programs show positive effects on obesity and lifestyle parameters. However, the effect of the programs delivered by different implementers is unknown, and in Mexico, the available studies present methodological limitations. The aim of this study is to evaluate the feasibility and efficacy of a school-based obesity prevention program implemented by nutrition and physical activity advanced students compared to a control group and implemented by school teachers compared to a control group of Mexican schoolchildren. This is a cluster randomized controlled trial. Schoolchildren from different public schools in Hermosillo , Sonora will be invited to participate. The schools will be randomly assigned to one option:1) the Planet Nutrition Program (PPN) delivered by advanced students, 2) PPN by school teachers, or 3) a control group. A 6-month pilot study with a follow-up at 8 months (after the summer holidays), followed by a definitive study with a follow-up at 8 and 12 months will be conducted.The intervention will consist of nutrition education sessions, physical activity, and the provision of nutrition information for parents. The BMI Z-score, body fat, other obesity, and lifestyle parameters will be evaluated at baseline and at the end of the study. A mixed effects model will be used to evaluate the differences between the groups. The investigators expect that the program could be a model of obesity prevention with a high potential for dissemination in Mexican schools.
Read the detailed description
This is a cluster randomized controlled trial. The study will be conducted in two phases. The first phase will be a 6-month pilot study with a follow-up at 8 months (after the summer holidays) to evaluate the feasibility: of retention, adherence, acceptability, and fidelity (Eldridge et al, 2010). The second will be a definitive study of 6 months with a follow-up at 8 and 12 months to evaluate the efficacy. The study will consist of three parallel, three-arm groups with a 1:1:1 allocation ratio.
To perform the protocol of the study, the SPIRIT 2013 guide was followed. The study was approved by the Research Ethics Committee of the University of Sonora Department of Nursing (EPD-007-2022).
Fifteen public schools (300 to 450 students) from Hermosillo, Sonora, Mexico will be conveniently invited to participate in the pilot study. The sample size was determined based on the capacity of providing the program and on finding possible positive effects on the variables of interest . The calculation of the sample size is not essential in a pilot study, where its main objective is to know the feasibility of the intervention and information regarding the response variables to later carry out the sample size calculation for a future definitive trial (Eldridge, 2016).
Once the informed consent and assent have been signed by the parents and children (respectively), the baseline measurements will be made over 4 weeks. The schools and participants that meet the inclusion/exclusion criteria will be randomly assigned to one of the three arms. 1). Planet Nutrition Program (PNP) implemented by nutrition and physical activity advanced students (studying the last semesters of the degree or who have completed subjects but do not have the degree), 2). PNP implemented by school teachers and 3). a control group. An independent person from the recruitment and the intervention will perform the random allocation of the schools. This will be stratified by socioeconomic level. The random number sequence will be generated using the software "Research Randomizer" https://randomizer.org/.
The baseline characteristics will be analyzed among groups, and an ANOVA analysis will be used for the quantitative variables, and a chi-square test for the categorical outcomes in order to assure that groups are similar in all variables. If there are significant differences among groups at baseline, an adjustment will be made in the analysis. To evaluate the differences between groups in the change of the BMI Z-score, body fat, and the other secondary variables at the beginning and at the end of the intervention, a mixed model will be used to consider the effect between groups and within groups. All analyzes will be performed by the intention to treat. If data is not obtained for any reason or subjects were excluded due to a protocol violation, they will be replaced by their baseline measurement. The R studio software will be used to perform the analysis.
- Conditions
- Pediatric Obesity
- Being tested
- Planet Nutrition Program
- Keywords
- Obesity prevention, School-based program, Nutrition education, Physical activity, Cluster randomized controlled trial
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planet Nutrition ProgramBehavioural
It is a 6-month school-based obesity prevention program that includes: nutrition education sessions, physical activity and family participation.
| Study group | Role | What they receive |
|---|---|---|
| Planet Nutrition Program (PNP) implemented by nutrition and physical activity advanced students | Experimental | The PNP consists of:
Nutrition education sessions: Nutrition advanced students of the University of Sonora will provide 1 face-to-face group class of one hour per week. The PNP handbook will be used to bring the different topics and dynamics to reinforce learning. The program will be focused on establishing some health-related goals.
Physical activity sessions: Three classes of 1 hour per week will be implemented by physical activity advanced students of the University of Sonora, independent of the school's curricular physical activity classes. A physical activity handbook designed by the study team will be used. Children will work on developing different skills.
Parents participation: They will receive one printed brochure with nutrition topics weekly. Also, they will be asked for their Facebook user (to create a private group) or the email to upload the information of the brochure and other didactic materials. Nutrition students will be in charge of providing the information. Receives: Behavioral: Planet Nutrition Program |
| Planet Nutrition (PNP) implemented by school teachers | Experimental | The PNP consists of:
Nutrition education sessions: Fourth grade school teachers will provide 1 face-to-face group class of one hour per week. The PNP handbook will be used to bring the different topics and dynamics to reinforce learning. The program will be focused on establishing some health-related goals.
Physical activity sessions: Three classes of 1 hour per week will be implemented by physical activity advanced students of the University of Sonora, independent of the school's curricular physical activity classes. A physical activity handbook designed by the study team will be used. Children will work on developing different skills.
Parents participation: They will receive one printed brochure with nutrition topics weekly. Also, they will be asked for their Facebook user (to create a private group) or the email and upload the information of the brochure and other didactic materials. School teachers will be in charge of providing the information. Receives: Behavioral: Planet Nutrition Program |
| Control Group | No intervention | Scholars of this group will continue with their normal school nutrition and physical activity classes. At the end of the study they will have access to the program materials through a web page. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention assessed by the number of participants/schools that complete the study (more information in the description).
This variable will be obtained with the number of schools and participants that complete the final measurements of the study. At 6 months, retention of participants and schools >80% will be considered excellent, >50-80 moderate, and <50 low retention.
Measured: At 6 months
Adherence evaluated with the number of sessions attended by the participants (more information in the description).
It will be evaluated with the number of attended sessions by schoolchildren and parents of the intervention groups. At 6 months, the attendance at program activities >80 will be considered excellent, >50-80 moderate, and <50 low attendance.
Measured: At 6 months.
Fidelity evaluated with the number of sessions provided by the implementers (more information in the description).
This will be evaluated with a questionnaire to ask implementers about the number of sessions and workshops implemented. Excellent fidelity to the study activities will be considered when ≥ 60% of the program is delivered, <60-40% moderate, and <40 % low.
Measured: At 6 months.
Acceptability of the intervention assessed by a questionnaire of the research team (information in the description).
The variable will be obtained with a questionnaire designed by the research group (not validated), applied to the children and parents of the intervention groups to qualify the program and materials. Also, to know about the benefits obtained with the program. A questionnaire will be provided to implementers to indicate their acceptance of the program and barriers to provide the sessions. It will be considered as good acceptance with a score of > 8-10 points, moderate acceptance > 5-8 points, and low acceptance ≤5 points.
Measured: At 6 months.
Change in the BMI Z-score
It will be the primary outcome for the definitive study. The BMI Z-score will be obtaining with the weight, height, gender and date of birth of the children, using the "Anthro Plus" software, which utilize the WHO reference tables (WHO,2007). The change in the outcome will be obtained by subtracting the value obtained at the final measurement from the baseline value.
Measured: Baseline, at 6 months, 8 months (after summer holidays), and for the definitive trial: baseline, 6 months, 8 months and after the 12 months of follow-up.
Change in Body fat
It will be the primary outcome for the definitive study. The tetrapolalar electrical bioimpedance method will be used to obtain the resistance and reactance values. The measurement will be carried out with a bioimpedance electrical equipment, RJL Quantum II, following the methodology used by Ramírez et al. With the data obtained, an equation designed to estimate fat-free mass in Mexican children will be used (Ramírez et al,2012). The change in the outcome will be obtained by subtracting the value obtained at the final measurement from the baseline value.
Measured: Baseline, at 6 months, 8 months (after summer holidays), and for the definitive trial: baseline, 6 months, 8 months and after the 12 months of follow-up.
Secondary outcomes (7)
Change in Weight
A TANITA SC-240 scale will be used to measure the body weight. The measurement will be take without shoes and accessories with light clothes. Children will stand in the center of the scale with their feet separated and arms at their sides. Measurement will be used to obtain the BMI Z-score (Gibson, 1990). The change in the outcome will be obtained by subtracting the value obtained at the final measurement from the baseline value.
Measured: Baseline, at 6 months and 8 months (after summer holidays), and for the definitive trial: baseline, 6 months, and after the 8 months and 12 months of follow-up.
Change in Waist circumference
A metallic anthropometric tape (Lufkin Executive Thineline W606PMM) will be used, taking the umbilical scar as measurement reference and in a standing position (Gibson,1990). The change in the outcome will be obtained by subtracting the value obtained at the final measurement from the baseline value.
Measured: Baseline and 6 months.
Change in Relative fat mass
This is an estimator of total body fat. The relative fat mass will be estimated using a formula validated with American children aged 8 to 14 years. Data of waist circumference (cm), height (cm) and sex will be used (Woolcott et al,2019). The change in the outcome will be obtained by subtracting the value obtained at the final measurement from the baseline value.
Measured: Baseline and 6 months.
Change in Food consumption
Some questions from the semi-quantitative food frequency questionnaire (FFQ) from the National Health and Nutrition Survey will be used.(Shamah-levy et al,2016).We will asked about the frequency of consumption of ultra-processed foods (sweet beverages, fried foods, cakes and cookies) and healthy foods (fruits, vegetables and water) in the previous 7 days. For each food, the size of the portion consumed will be asked, considering an average portion established in the FFQ. The change in the outcome will be obtained by subtracting the value obtained at the final measurement from the baseline value.
Measured: Baseline and 6 months.
Change in Physical activity and sedentary behavior
The questions on physical activity and sedentary lifestyle will be used from the questionnaire, "The Health Behavior in School-Age Children" (HBSC) (Currie et al,2014). It includes the days and the time dedicated to physical activity and sedentary activities during the last 7 days in sedentary activities during the week and at the weekend. The change in the outcome will be obtained by subtracting the value obtained at the final measurement from the baseline value.
Measured: Baseline and 6 months.
Chane in Quality of life, assessed by PedsQL (more information in the description)
The PedsQL™ questionnaire (Pediatric Quality of Life Inventory) will be used. This generic health status instrument assesses the frequency of problems experienced in the past month in physical, emotional, social, and school functioning. Responses are on a 5-point likert scale (never = 0 to always = 4). The score for each item is inverted and converted to a linear scale from 0 to 100, a higher score indicates a better quality of life (Varni et al,2001).The change in the outcome will be obtained by subtracting the value obtained at the final measurement from the baseline value.
Measured: Baseline and 6 months.
Nutrition knowledge
A questionnaire designed by the study team will be used to assess knowledge on nutrition issues. It consists of 32 questions about nutrition and health. They will be evaluated on a scale from 0 to 10, the more correct answers, the higher the score.The change in the outcome will be obtained by subtracting the value obtained at the final measurement from the baseline value.
Measured: Baseline and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start5 Dec 2022
- Primary completionJun 2023 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a cluster randomized controlled trial. The study will be conducted in two phases. The first will be a 6-month pilot study with a follow-up at 8 months (after the summer holidays) and the second a definitive study of 6 months with a follow-up at 8 and 12 months. The study will consist of three parallel, three-arm groups with a 1:1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Sonora
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Investigación en Alimentación y Desarrollo A.C., Instituto Nacional de Geriatria, Mexico, Universidad de León
- Responsible party
- Principal investigator, Rolando Giovanni Díaz Zavala, Universidad de Sonora
- Investigators
- Rolando G Díaz Zavala, PhD, Principal investigator, Universidad de Sonora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461703
- Sponsor's protocol ID
- PNP02
- Status last verified
- Jan 2023
- First submitted
- 13 Jul 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
World Health Organization (WHO). Obesity and Overweight. [Internet]. 2018 [cited 2019 Oct 10]. Available from: https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight
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.
PubMed 29029897Shamah-Levy T, Vielma-Orozco E, Heredia-Hernández O, Romero-Martínez M, Mojica-Cuevas J C-NL, Santaella-Castell JA R-DJ. Encuesta Nacional de Salud y Nutrición 2018-19: Resultados Nacionales. [Internet]. Cuernavaca, México; 2020. Available from: https://ensanut.insp.mx/encuestas/ensanut2018/informes.php
Obesity Evidence Hub. Obesity trends in children globally [Internet]. 2021 [cited 2021 Nov 20]. Available from: https://www.obesityevidencehub.org.au/collections/trends/children-global-context
Sharma V, Coleman S, Nixon J, Sharples L, Hamilton-Shield J, Rutter H, Bryant M. A systematic review and meta-analysis estimating the population prevalence of comorbidities in children and adolescents aged 5 to 18 years. Obes Rev. 2019 Oct;20(10):1341-1349. doi: 10.1111/obr.12904. Epub 2019 Jul 24.
PubMed 31342672Lambrinou CP, Androutsos O, Karaglani E, Cardon G, Huys N, Wikstrom K, Kivela J, Ko W, Karuranga E, Tsochev K, Iotova V, Dimova R, De Miguel-Etayo P, M Gonzalez-Gil E, Tamas H, Jancso Z, Liatis S, Makrilakis K, Manios Y; Feel4Diabetes-study group. Effective strategies for childhood obesity prevention via school based, family involved interventions: a critical review for the development of the Feel4Diabetes-study school based component. BMC Endocr Disord. 2020 May 6;20(Suppl 2):52. doi: 10.1186/s12902-020-0526-5.
PubMed 32370795WHO. Population-based approaches to childhood obesity prevention [Internet]. Geneva, Switzerland; 2012. Available from: https://www.who.int/dietphysicalactivity/childhood/WHO_new_childhoodobesity_PREVENTION_27nov_HR_PRINT_OK.pdf
Pulimeno M, Piscitelli P, Colazzo S, Colao A, Miani A. School as ideal setting to promote health and wellbeing among young people. Health Promot Perspect. 2020 Nov 7;10(4):316-324. doi: 10.34172/hpp.2020.50. eCollection 2020.
PubMed 33312927Brown 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(7):CD001871. doi: 10.1002/14651858.CD001871.pub4.
PubMed 31332776Singhal J, Herd C, Adab P, Pallan M. Effectiveness of school-based interventions to prevent obesity among children aged 4 to 12 years old in middle-income countries: A systematic review and meta-analysis. Obes Rev. 2021 Jan;22(1):e13105. doi: 10.1111/obr.13105. Epub 2020 Jul 28.
PubMed 32725780Aceves-Martins M, Lopez-Cruz L, Garcia-Botello M, Gutierrez-Gomez YY, Moreno-Garcia CF. Interventions to Prevent Obesity in Mexican Children and Adolescents: Systematic Review. Prev Sci. 2022 May;23(4):563-586. doi: 10.1007/s11121-021-01316-6. Epub 2021 Nov 2.
PubMed 34725762Ramirez-Rivera DL, Martinez-Contreras T, Villegas-Valle RC, Henry-Mejia G, Quizan-Plata T, Haby MM, Diaz-Zavala RG. Preliminary Results of the Planet Nutrition Program on Obesity Parameters in Mexican Schoolchildren: Pilot Single-School Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jan 18;18(2):790. doi: 10.3390/ijerph18020790.
PubMed 33477722Ramírez-Rivera DL, Martínez-Contreras T, Henry-Mejia G, Ruelas AL, Quizán-Plata T, Esparza-Romero J, Díaz-Zavala RG. Efecto de una intervención en línea de cambio en el estilo de vida sobre el puntaje zIMC de escolares mexicanos: protocolo de ensayo controlado aleatorizado piloto cegado a evaluadores durante la pandemia por COVID-19. Rev Esp Nutr Hum Diet 2021;25.
Diaz-Zavala RG, Castro-Cantu MF, Valencia ME, Alvarez-Hernandez 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.
PubMed 28744374Franckle 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.
PubMed 24921899
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Efficacy of a School-based Obesity Prevention Program Delivery by Nutrition and Physical Activity Advanced Students or School Teachers on the BMI Z-score and Body Fat at 6 Months of Mexican Children: a Cluster Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT05461703
- Acronym / sponsor ID
- PNP02
- Conditions
- Pediatric Obesity
- Keywords
- Obesity prevention, School-based program, Nutrition education, Physical activity, Cluster randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Universidad de SonoraUniversity, hospital or other
- Collaborators
- Centro de Investigación en Alimentación y Desarrollo A.C., Instituto Nacional de Geriatria, Mexico, Universidad de León
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is evidence that obesity prevention programs show positive effects on obesity and lifestyle parameters. However, the effect of the programs delivered by different implementers is unknown, and in Mexico, the available studies present methodological limitations. The aim of this study is to evaluate the feasibility and efficacy of a school-based obesity prevention program implemented by nutrition and physical activity advanced students compared to a control group and implemented by school teachers compared to a control group of Mexican schoolchildren. This is a cluster randomized controlled trial. Schoolchildren from different public schools in Hermosillo , Sonora will be invited to participate. The schools will be randomly assigned to one option:1) the Planet Nutrition Program (PPN) delivered by advanced students, 2) PPN by school teachers, or 3) a control group. A 6-month pilot study with a follow-up at 8 months (after the summer holidays), followed by a definitive study with a follow-up at 8 and 12 months will be conducted.The intervention will consist of nutrition education sessions, physical activity, and the provision of nutrition information for parents. The BMI Z-score, body fat, other obesity, and lifestyle parameters will be evaluated at baseline and at the end of the study. A mixed effects model will be used to evaluate the differences between the groups. The investigators expect that the program could be a model of obesity prevention with a high potential for dissemination in Mexican schools.
Detailed description
This is a cluster randomized controlled trial. The study will be conducted in two phases. The first phase will be a 6-month pilot study with a follow-up at 8 months (after the summer holidays) to evaluate the feasibility: of retention, adherence, acceptability, and fidelity (Eldridge et al, 2010). The second will be a definitive study of 6 months with a follow-up at 8 and 12 months to evaluate the efficacy. The study will consist of three parallel, three-arm groups with a 1:1:1 allocation ratio.
To perform the protocol of the study, the SPIRIT 2013 guide was followed. The study was approved by the Research Ethics Committee of the University of Sonora Department of Nursing (EPD-007-2022).
Fifteen public schools (300 to 450 students) from Hermosillo, Sonora, Mexico will be conveniently invited to participate in the pilot study. The sample size was determined based on the capacity of providing the program and on finding possible positive effects on the variables of interest . The calculation of the sample size is not essential in a pilot study, where its main objective is to know the feasibility of the intervention and information regarding the response variables to later carry out the sample size calculation for a future definitive trial (Eldridge, 2016).
Once the informed consent and assent have been signed by the parents and children (respectively), the baseline measurements will be made over 4 weeks. The schools and participants that meet the inclusion/exclusion criteria will be randomly assigned to one of the three arms. 1). Planet Nutrition Program (PNP) implemented by nutrition and physical activity advanced students (studying the last semesters of the degree or who have completed subjects but do not have the degree), 2). PNP implemented by school teachers and 3). a control group. An independent person from the recruitment and the intervention will perform the random allocation of the schools. This will be stratified by socioeconomic level. The random number sequence will be generated using the software "Research Randomizer" https://randomizer.org/.
The baseline characteristics will be analyzed among groups, and an ANOVA analysis will be used for the quantitative variables, and a chi-square test for the categorical outcomes in order to assure that groups are similar in all variables. If there are significant differences among groups at baseline, an adjustment will be made in the analysis. To evaluate the differences between groups in the change of the BMI Z-score, body fat, and the other secondary variables at the beginning and at the end of the intervention, a mixed model will be used to consider the effect between groups and within groups. All analyzes will be performed by the intention to treat. If data is not obtained for any reason or subjects were excluded due to a protocol violation, they will be replaced by their baseline measurement. The R studio software will be used to perform the analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- This is a cluster randomized controlled trial. The study will be conducted in two phases. The first will be a 6-month pilot study with a follow-up at 8 months (after the summer holidays) and the second a definitive study of 6 months with a follow-up at 8 and 12 months. The study will consist of three parallel, three-arm groups with a 1:1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Planet Nutrition Program (PNP) implemented by nutrition and physical activity advanced students | Experimental | Behavioral: Planet Nutrition ProgramThe PNP consists of: Nutrition education sessions: Nutrition advanced students of the University of Sonora will provide 1 face-to-face group class of one hour per week. The PNP handbook will be used to bring the different topics and dynamics to reinforce learning. The program will be focused on establishing some health-related goals. Physical activity sessions: Three classes of 1 hour per week will be implemented by physical activity advanced students of the University of Sonora, independent of the school's curricular physical activity classes. A physical activity handbook designed by the study team will be used. Children will work on developing different skills. Parents participation: They will receive one printed brochure with nutrition topics weekly. Also, they will be asked for their Facebook user (to create a private group) or the email to upload the information of the brochure and other didactic materials. Nutrition students will be in charge of providing the information. |
| Planet Nutrition (PNP) implemented by school teachers | Experimental | Behavioral: Planet Nutrition ProgramThe PNP consists of: Nutrition education sessions: Fourth grade school teachers will provide 1 face-to-face group class of one hour per week. The PNP handbook will be used to bring the different topics and dynamics to reinforce learning. The program will be focused on establishing some health-related goals. Physical activity sessions: Three classes of 1 hour per week will be implemented by physical activity advanced students of the University of Sonora, independent of the school's curricular physical activity classes. A physical activity handbook designed by the study team will be used. Children will work on developing different skills. Parents participation: They will receive one printed brochure with nutrition topics weekly. Also, they will be asked for their Facebook user (to create a private group) or the email and upload the information of the brochure and other didactic materials. School teachers will be in charge of providing the information. |
| Control Group | No intervention | –Scholars of this group will continue with their normal school nutrition and physical activity classes. At the end of the study they will have access to the program materials through a web page. |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Schools:
- Schoolchildren:
- -be a 4th grade student (9 to 11 years old).
- Implemeters:
Key exclusion criteria (2 listed)
- Schools: participating in another similar study.
- Schoolchildren: Having a personal condition that prevents physical activity or a condition that parents consider should not involve the child.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Planet Nutrition ProgramIt is a 6-month school-based obesity prevention program that includes: nutrition education sessions, physical activity and family participation. | Behavioural | Planet Nutrition (PNP) implemented by school teachers, Planet Nutrition Program (PNP) implemented by nutrition and physical activity advanced students |
Primary outcome
Retention assessed by the number of participants/schools that complete the study (more information in the description).
Time frame: At 6 months
This variable will be obtained with the number of schools and participants that complete the final measurements of the study. At 6 months, retention of participants and schools >80% will be considered excellent, >50-80 moderate, and <50 low retention.
Adherence evaluated with the number of sessions attended by the participants (more information in the description).
Time frame: At 6 months.
It will be evaluated with the number of attended sessions by schoolchildren and parents of the intervention groups. At 6 months, the attendance at program activities >80 will be considered excellent, >50-80 moderate, and <50 low attendance.
Fidelity evaluated with the number of sessions provided by the implementers (more information in the description).
Time frame: At 6 months.
This will be evaluated with a questionnaire to ask implementers about the number of sessions and workshops implemented. Excellent fidelity to the study activities will be considered when ≥ 60% of the program is delivered, <60-40% moderate, and <40 % low.
Acceptability of the intervention assessed by a questionnaire of the research team (information in the description).
Time frame: At 6 months.
The variable will be obtained with a questionnaire designed by the research group (not validated), applied to the children and parents of the intervention groups to qualify the program and materials. Also, to know about the benefits obtained with the program. A questionnaire will be provided to implementers to indicate their acceptance of the program and barriers to provide the sessions. It will be considered as good acceptance with a score of > 8-10 points, moderate acceptance > 5-8 points, and low acceptance ≤5 points.
Change in the BMI Z-score
Time frame: Baseline, at 6 months, 8 months (after summer holidays), and for the definitive trial: baseline, 6 months, 8 months and after the 12 months of follow-up.
It will be the primary outcome for the definitive study. The BMI Z-score will be obtaining with the weight, height, gender and date of birth of the children, using the "Anthro Plus" software, which utilize the WHO reference tables (WHO,2007). The change in the outcome will be obtained by subtracting the value obtained at the final measurement from the baseline value.
Change in Body fat
Time frame: Baseline, at 6 months, 8 months (after summer holidays), and for the definitive trial: baseline, 6 months, 8 months and after the 12 months of follow-up.
It will be the primary outcome for the definitive study. The tetrapolalar electrical bioimpedance method will be used to obtain the resistance and reactance values. The measurement will be carried out with a bioimpedance electrical equipment, RJL Quantum II, following the methodology used by Ramírez et al. With the data obtained, an equation designed to estimate fat-free mass in Mexican children will be used (Ramírez et al,2012). The change in the outcome will be obtained by subtracting the value obtained at the final measurement from the baseline value.
7 secondary outcomes
Change in Weight
Time frame: Baseline, at 6 months and 8 months (after summer holidays), and for the definitive trial: baseline, 6 months, and after the 8 months and 12 months of follow-up.
Change in Waist circumference
Time frame: Baseline and 6 months.
Change in Relative fat mass
Time frame: Baseline and 6 months.
Change in Food consumption
Time frame: Baseline and 6 months.
Change in Physical activity and sedentary behavior
Time frame: Baseline and 6 months.
Chane in Quality of life, assessed by PedsQL (more information in the description)
Time frame: Baseline and 6 months.
Nutrition knowledge
Time frame: Baseline and 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- BackgroundWorld Health Organization (WHO). Obesity and Overweight. [Internet]. 2018 [cited 2019 Oct 10]. Available from: https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight
- Background: PubMed 29029897NCD 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.
- BackgroundShamah-Levy T, Vielma-Orozco E, Heredia-Hernández O, Romero-Martínez M, Mojica-Cuevas J C-NL, Santaella-Castell JA R-DJ. Encuesta Nacional de Salud y Nutrición 2018-19: Resultados Nacionales. [Internet]. Cuernavaca, México; 2020. Available from: https://ensanut.insp.mx/encuestas/ensanut2018/informes.php
- BackgroundObesity Evidence Hub. Obesity trends in children globally [Internet]. 2021 [cited 2021 Nov 20]. Available from: https://www.obesityevidencehub.org.au/collections/trends/children-global-context
- Background: PubMed 31342672Sharma V, Coleman S, Nixon J, Sharples L, Hamilton-Shield J, Rutter H, Bryant M. A systematic review and meta-analysis estimating the population prevalence of comorbidities in children and adolescents aged 5 to 18 years. Obes Rev. 2019 Oct;20(10):1341-1349. doi: 10.1111/obr.12904. Epub 2019 Jul 24.
- Background: PubMed 32370795Lambrinou CP, Androutsos O, Karaglani E, Cardon G, Huys N, Wikstrom K, Kivela J, Ko W, Karuranga E, Tsochev K, Iotova V, Dimova R, De Miguel-Etayo P, M Gonzalez-Gil E, Tamas H, Jancso Z, Liatis S, Makrilakis K, Manios Y; Feel4Diabetes-study group. Effective strategies for childhood obesity prevention via school based, family involved interventions: a critical review for the development of the Feel4Diabetes-study school based component. BMC Endocr Disord. 2020 May 6;20(Suppl 2):52. doi: 10.1186/s12902-020-0526-5.
- BackgroundWHO. Population-based approaches to childhood obesity prevention [Internet]. Geneva, Switzerland; 2012. Available from: https://www.who.int/dietphysicalactivity/childhood/WHO_new_childhoodobesity_PREVENTION_27nov_HR_PRINT_OK.pdf
- Background: PubMed 33312927Pulimeno M, Piscitelli P, Colazzo S, Colao A, Miani A. School as ideal setting to promote health and wellbeing among young people. Health Promot Perspect. 2020 Nov 7;10(4):316-324. doi: 10.34172/hpp.2020.50. eCollection 2020.
- Background: PubMed 31332776Brown 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(7):CD001871. doi: 10.1002/14651858.CD001871.pub4.
- Background: PubMed 32725780Singhal J, Herd C, Adab P, Pallan M. Effectiveness of school-based interventions to prevent obesity among children aged 4 to 12 years old in middle-income countries: A systematic review and meta-analysis. Obes Rev. 2021 Jan;22(1):e13105. doi: 10.1111/obr.13105. Epub 2020 Jul 28.
- Background: PubMed 34725762Aceves-Martins M, Lopez-Cruz L, Garcia-Botello M, Gutierrez-Gomez YY, Moreno-Garcia CF. Interventions to Prevent Obesity in Mexican Children and Adolescents: Systematic Review. Prev Sci. 2022 May;23(4):563-586. doi: 10.1007/s11121-021-01316-6. Epub 2021 Nov 2.
- Background: PubMed 33477722Ramirez-Rivera DL, Martinez-Contreras T, Villegas-Valle RC, Henry-Mejia G, Quizan-Plata T, Haby MM, Diaz-Zavala RG. Preliminary Results of the Planet Nutrition Program on Obesity Parameters in Mexican Schoolchildren: Pilot Single-School Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jan 18;18(2):790. doi: 10.3390/ijerph18020790.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana L Ramírez Rivera, MSc contact
Rolando G Díaz Zavala, PhD principal investigator
Universidad de Sonora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Planet Nutrition Program in people with Pediatric Obesity, run by Universidad de Sonora at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rolando G Díaz Zavala, PhD (6622592250, giovanni.diaz@unison.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention assessed by the number of participants/schools that complete the study (more information in the description). (time frame: At 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05461703, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.