Pediatric ObesityNCT03459742
Juntos Santiago: Gamification Strategy to Reduce Childhood Obesity in Schools in Santiago de Chile
A study testing Gamification strategy in people with Pediatric Obesity, run by Municipality of Santiago at 2 sites in Chile.
Trial summary
School-based interventions have shown mixed results. Most studies have lacked enough statistical power and have been carried out in North America and Europe. The Juntos Santiago is a cluster-randomized trial based on a gamification strategy conducted in Santiago de Chile. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Gamification strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 2 sitesChile
- Study dates
- 9 Apr 2018to Dec 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Students in schools in Santiago in 5th and 6th grade (approximately 10 and 11 years old)
- Willingness to participate in the intervention and measurements
- Able to read Spanish and accurately complete dietary assessments
- Any weight status
Who cannot join
- School not accepting to participate in the study
- Class votes against enrolling in the study
- Caretaker does not grant permission to participate
Trial locations and contacts
2 sites in 1 country.
Chile2 sites, 2 recruiting
- Recruiting
Estacion Central
Santiago, N/A = Not Applicable, 8320077
Valeska Müller, 0974212849, vmuller@munistgo.cl
Valeska Müller, LDN
- Recruiting
Santiago
Santiago, N/A = Not Applicable, 8320077
Valeska Müller, LDN, +56974212849, vmuller@munistgo.cl
vmuller@munistgo.cl
About this study
Official title: A Gamification Strategy to Reduce Childhood Obesity in Santiago Schools: a Cluster Randomized Controlled Trial
School-based interventions have shown mixed results. Most studies have lacked enough statistical power and have been carried out in North America and Europe.
The Juntos Santiago is a cluster-randomized trial based on a gamification strategy conducted in Santiago de Chile. The trial uses elements of a game such as points, levels and rewards along with a strong community participation component.
Children voted their enrollment and collectively chose the rewards (two per year, one activity and another structural) they are playing for. The intervention consists of a healthy snacks challenge, a steps challenge and an activity challenge. The primary outcome is change in z-BMI and waist circumference.
Read the detailed description
Purpose
Childhood obesity has reached epidemic proportions in the last decades. The growing obesity epidemic has negative health, economic and social consequences (Wang et al., 2011, Withrow and Alter, 2011, Griffiths et al., 2010). These include an increased risk of type 2 diabetes, cardiovascular diseases and cancer, a shorter life expectancy and lower quality of life (Wang et al., 2011, Olshansky et al., 2005). Studies suggest obese and physically inactive kids also have lower academic achievement (Correa-Burrows et al., 2016, Garcia-Hermoso and Marina, 2017).
The school environment is a suitable setting for implementing evidence-based interventions to reduce obesity. Several systematic reviews of RCTs have shown a modest decrease in adiposity and blood pressure (Oosterhoff et al., 2016, Wang et al., 2015, Sobol-Goldberg et al., 2013, Mei et al., 2016, Vasques et al., 2014). Oosterhoff et al (2016) showed a significant reduction in BMI of 0.22 kg/mt2 and systolic blood pressure, while no effect was found for diastolic blood pressure (Oosterhoff et al., 2016).
Multicomponent interventions addressing both nutrition and physical activity and involving parents and the school community have shown to be more effective (Wang et al., 2015). Few studies, however, have used a structured motivational strategy to increase engagement of students and school communities.
The clustered-randomized controlled trial Juntos Santiago was designed as a multidimensional intervention that incorporates a gamification strategy to increase motivation and participation. The intervention addresses the snacks brought from home, encourages physical activity and active parent and school community participation. All the aspects of the intervention are brought together in a game that provides points, levels and rewards that improve school infrastructure for better nutrition and physical activity. Structural rewards contribute to a sustained effect of the intervention.
The purpose of the Juntos Santiago study is to examine the effectiveness of a multicomponent school-based gamification strategy to reduce the body mass index (BMI), waist circumference (WC) and systolic blood pressure (SBP) in school children in 5th and 6th grade, compared to usual care and a leaflet and designed to prevent obesity.
Intervention
The study is part of the Juntos Santiago project, which will be progressively scaled-up for three years. A pilot will be carried out in three schools during 2017, without a control group. In 2018, the trial will include 12 randomly selected schools; the control group will be randomly selected from schools in the Municipality of Santiago plus 4 schools in a neighbour municipality (Estación Central). In 2019, the trial will expand to include all eligible schools in the Municipality of Santiago and 4000 students in the control group from neighbouring municipalities.
The intervention is based on the socio-ecological model. The intervention is a gamification strategy consisting of four components:
Gamification incentives, including the use of points, levels and rewards, to promote behavioural and structural change in the schools. The gamification strategy bundles the intervention components together.
Healthy challenges. Children will be invited to participate in healthy challenges. They will score points, which will result in progressing into a next level and win rewards at the end of the year. There will be three types of challenges:
Healthy snacks challenge, where children collect points for bringing healthy snacks for school breaks.
Steps challenge, where children and one caretaker are given an activity tracker three times a year for two weeks. Points are collected each time a child or a caretaker surpasses a daily threshold level Activity challenge, where children and their families collect points by uploading pictures of specific healthy activities defined by the research team.
Levels. The intervention will take place throughout the year (8 months from March to November). There will be three levels, each associated with a specific reward. Level 1 is the starting point. Level 2 is planned to be reached by 100% at 4 months of the intervention. Level 3 is planned be reached by 70% towards the end of the intervention year. A new cycle will start in 2019.
Rewards. The intervention includes the following rewards:
An initial reward (Starting Kit). The Starting Kit is a box that includes project souvenirs for students, guidelines on healthy snacks and physical activity for children and their families and 12 teaching modules on healthy behaviours designed for teachers. The Starting Kit is delivered upon enrolment in the trial.
An structural reward (SR) when reaching level 2. This reward will be achieved collectively by all participating classes in one school. The reward will be selected from a closed list and will consist of improvements of the school infrastructure to promote a healthy nutrition and physical activity (e.g. a school garden, playground facilities, climbing wall, shared bicycles, sports equipment).
An activity reward (AR) when reaching level 3. This reward will be achieved by each class and will consist of a fun and healthy activity. For example, the visit of a famous sport player, an outdoor trip, tickets to an amusement park, etc.
Parental involvement. Parents will be involved indirectly by the healthy snacks and directly in the steps and activity challenges. Parents will receive a SMS each time points are awarded.
A web platform will be developed for schools and classes to track progress of their points, levels and rewards. An individual login by each student will allow the student and their families to check the results of the anthropometric measurements and points awarded.
Measurements Intervention measurement Healthy snacks. Healthy snacks will be measured three times per month by a trained team. In packaged snacks, data will be collected using the stock keeping unit (SKU) in the barcode. Non-packaged foods will be divided into predefined categories. A food composition database including the calories, saturated fats, total sugar and salt per 100 grams has been developed for this purpose. Indicators: Mean change in calories, saturated fat, total sugar and salt per 100 grams.
Steps challenge. Steps will be measured using a validated activity tracker for 14 days. The mean daily steps will be measured. Indicator: Mean change in total daily steps.
Activity challenge. The research team will define activities were children and families who complete these activity challenges will collect points. This include activities organized by the Municipality of Santiago (i.e. a City run), healthy activities to do as a family (such as cycling or walking together or having a healthy lunch following predefined guidelines), and class activities organized by the teacher following also predefined guidelines. Students and their families will upload pictures of these activities to the web platform to collect the points. A validation system Given the All uploaded pictures Indicator: Mean change in number of completed activity challenges.
Intermediate variables A self-administered questionnaire will be applied at baseline and month 8. The questionnaire includes validated instruments to assess consumption of fruits and vegetables, unhealthy snacks and moderate and vigorous physical activity (MVPA). Consumption of food and vegetables and unhealthy snacks will be measured using the instrument validated by Lera et al (2015) developed in Chilean children aged 10 to 11 years old.12 Additionally, questions from the Global School Health Survey 2013 developed jointly by the Centre for Disease Prevention (CDC) and the Ministry of Health (MoH).
Physical activity will be measured using the PAQ-C. PAQ-C has shown high validity and reliability in different settings. The study will use the PAQ-C version implemented in Chilean schools by Zuñiga et al (2017).13 Questions from the GSHS 2013 on physical activity will also be included.
Adverse effects The study will monitor the experience of bullying, as a possible adverse effect of the intervention, using two questions from the GSHS 2013 on the frequency of bullying in the past 30 days and type of bullying.
- Conditions
- Pediatric Obesity
- Being tested
- Gamification strategy
- Keywords
- Obesity, Gamification, Schools, Cluster Randomized Trial
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamification strategyBehavioural
The intervention is a gamification strategy, including game elements such as points, levels and rewards. Points are scored by completion of healthy challenges, i.e. a healthy snacks challenge, a steps challenge and activity challenge. Intervention takes place for 8 months from Mar to Nov. There will be three levels. Level 1 at baseline, level 2 expected at month 4 by 100% of participants and level 3 expected in month 8 by 70% of participants. A new cycle will start in 2019.
Rewards include an initial reward (Starting Kit), a structural reward and an activity reward. The Starting Kit is a box with souvenirs, information for students and teachers. A structural reward, at level 2, will be achieved collectively by all participating classes in one school. It consists of school infrastructure improvements to promote a healthy nutrition and PA (eg. climbing wall, shared bicycles, sports equipment). An activity reward (AR), when reaching level 3, consists of a fun and healthy activity.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Gamification strategy. In 2018, the intervention group are 15 schools from Municipality of Santiago. In 2019, the intervention will cover all eligible schools in the Municipality of Santiago. Receives: Behavioral: Gamification strategy |
| Control | No intervention | In 2018, the control group will be 5 randomly selected schools from Municipality of Santiago and 4 schools from Municipality of Estación Central. In 2019, the control group will be 4000 participants chosen from neighboring municipalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in zBMI
Change in zscore of body mass index at 8 months
Measured: Measured at baseline and 8 months
Change in waist circumference
Change in waist circumference measured using standard protocols at 8 months
Measured: Measured at baseline and 8 months
Secondary outcomes (3)
Change in BMI
Change in body mass index (weight/height squared) at 8 months. Weight and height will be combined to report BMI in kg/m^2
Measured: Measured at baseline and 8 months
Change in SBP
Change in systolic blood pressure at 8 months
Measured: Measured at baseline and 8 months
Change in DBP
Change in diastolic blood pressure at 8 months
Measured: Measured at baseline and 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start9 Apr 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- Cluster randomized controlled trial. The randomization unit will be the schools. The primary outcome will be measured individually, but the effect size will also be calculated at the school level.
- Masking
- None (open label)
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Municipality of Santiago
- Sponsor type
- Other government
- Collaborators
- Delivery Associates, Bloomberg Philanthropies, University of Chile, Pontificia Universidad Catolica de Chile, Ministry of Health, Chile
- Responsible party
- Sponsor
- Investigators
- Sebastián Peña, MD, MSc, Study chair, Finnish Institute for Health and WelfareMacarena Carranza, LDN, MSc, Principal investigator, Municipality of SantiagoPedro Zitko, MD, MSc, Study chair, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459742
- Sponsor's protocol ID
- Secc. 2da. 11058
- Status last verified
- Jul 2018
- First submitted
- 18 Feb 2018
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data without unique personal identification number will be available to associated researchers
Publications
Wang YC, McPherson K, Marsh T, Gortmaker SL, Brown M. Health and economic burden of the projected obesity trends in the USA and the UK. Lancet. 2011 Aug 27;378(9793):815-25. doi: 10.1016/S0140-6736(11)60814-3.
PubMed 21872750Withrow D, Alter DA. The economic burden of obesity worldwide: a systematic review of the direct costs of obesity. Obes Rev. 2011 Feb;12(2):131-41. doi: 10.1111/j.1467-789X.2009.00712.x.
PubMed 20122135Griffiths LJ, Parsons TJ, Hill AJ. Self-esteem and quality of life in obese children and adolescents: a systematic review. Int J Pediatr Obes. 2010 Aug;5(4):282-304. doi: 10.3109/17477160903473697.
PubMed 20210677Olshansky SJ, Passaro DJ, Hershow RC, Layden J, Carnes BA, Brody J, Hayflick L, Butler RN, Allison DB, Ludwig DS. A potential decline in life expectancy in the United States in the 21st century. N Engl J Med. 2005 Mar 17;352(11):1138-45. doi: 10.1056/NEJMsr043743.
PubMed 15784668Correa-Burrows P, Burrows R, Blanco E, Reyes M, Gahagan S. Nutritional quality of diet and academic performance in Chilean students. Bull World Health Organ. 2016 Mar 1;94(3):185-92. doi: 10.2471/BLT.15.161315. Epub 2016 Feb 3.
PubMed 26966329Garcia-Hermoso A, Marina R. Relationship of weight status, physical activity and screen time with academic achievement in adolescents. Obes Res Clin Pract. 2017 Jan-Feb;11(1):44-50. doi: 10.1016/j.orcp.2015.07.006. Epub 2015 Aug 3.
PubMed 26249128Oosterhoff M, Joore M, Ferreira I. The effects of school-based lifestyle interventions on body mass index and blood pressure: a multivariate multilevel meta-analysis of randomized controlled trials. Obes Rev. 2016 Nov;17(11):1131-1153. doi: 10.1111/obr.12446. Epub 2016 Jul 19.
PubMed 27432468Wang Y, Cai L, Wu Y, Wilson RF, Weston C, Fawole O, Bleich SN, Cheskin LJ, Showell NN, Lau BD, Chiu DT, Zhang A, Segal J. What childhood obesity prevention programmes work? A systematic review and meta-analysis. Obes Rev. 2015 Jul;16(7):547-65. doi: 10.1111/obr.12277. Epub 2015 Apr 20.
PubMed 25893796Sobol-Goldberg S, Rabinowitz J, Gross R. School-based obesity prevention programs: a meta-analysis of randomized controlled trials. Obesity (Silver Spring). 2013 Dec;21(12):2422-8. doi: 10.1002/oby.20515. Epub 2013 Aug 13.
PubMed 23794226Mei H, Xiong Y, Xie S, Guo S, Li Y, Guo B, Zhang J. The impact of long-term school-based physical activity interventions on body mass index of primary school children - a meta-analysis of randomized controlled trials. BMC Public Health. 2016 Mar 1;16:205. doi: 10.1186/s12889-016-2829-z.
PubMed 26931236Vasques C, Magalhaes P, Cortinhas A, Mota P, Leitao J, Lopes VP. Effects of intervention programs on child and adolescent BMI: A meta-analysis study. J Phys Act Health. 2014 Feb;11(2):426-44. doi: 10.1123/jpah.2012-0035. Epub 2013 Jan 30.
PubMed 23363556Lera L, Fretes G, Gonzalez CG, Salinas J, Vio del Rio F. [Validity of an instrument for assessing food consumption, food habits and cooking skills in 8-11 years old students]. Nutr Hosp. 2015 May 1;31(5):1977-88. doi: 10.3305/nh.2015.31.5.8607. Spanish.
PubMed 25929365Zurita-Ortega F, Castro-Sanchez M, Rodriguez-Fernandez S, Cofre-Bolados C, Chacon-Cuberos R, Martinez-Martinez A, Muros-Molina JJ. [Physical activity, obesity and self-esteem in chilean schoolchildren]. Rev Med Chil. 2017 Mar;145(3):299-308. doi: 10.4067/S0034-98872017000300006. Spanish.
PubMed 28548189
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Gamification Strategy to Reduce Childhood Obesity in Santiago Schools: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03459742
- Acronym / sponsor ID
- Secc. 2da. 11058
- Conditions
- Pediatric Obesity
- Keywords
- Obesity, Gamification, Schools, Cluster Randomized Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Municipality of SantiagoOther government
- Collaborators
- Delivery Associates, Bloomberg Philanthropies, University of Chile, Pontificia Universidad Catolica de Chile, Ministry of Health, Chile
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 9 Mar 2018 (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.
School-based interventions have shown mixed results. Most studies have lacked enough statistical power and have been carried out in North America and Europe.
The Juntos Santiago is a cluster-randomized trial based on a gamification strategy conducted in Santiago de Chile. The trial uses elements of a game such as points, levels and rewards along with a strong community participation component.
Children voted their enrollment and collectively chose the rewards (two per year, one activity and another structural) they are playing for. The intervention consists of a healthy snacks challenge, a steps challenge and an activity challenge. The primary outcome is change in z-BMI and waist circumference.
Detailed description
Purpose
Childhood obesity has reached epidemic proportions in the last decades. The growing obesity epidemic has negative health, economic and social consequences (Wang et al., 2011, Withrow and Alter, 2011, Griffiths et al., 2010). These include an increased risk of type 2 diabetes, cardiovascular diseases and cancer, a shorter life expectancy and lower quality of life (Wang et al., 2011, Olshansky et al., 2005). Studies suggest obese and physically inactive kids also have lower academic achievement (Correa-Burrows et al., 2016, Garcia-Hermoso and Marina, 2017).
The school environment is a suitable setting for implementing evidence-based interventions to reduce obesity. Several systematic reviews of RCTs have shown a modest decrease in adiposity and blood pressure (Oosterhoff et al., 2016, Wang et al., 2015, Sobol-Goldberg et al., 2013, Mei et al., 2016, Vasques et al., 2014). Oosterhoff et al (2016) showed a significant reduction in BMI of 0.22 kg/mt2 and systolic blood pressure, while no effect was found for diastolic blood pressure (Oosterhoff et al., 2016).
Multicomponent interventions addressing both nutrition and physical activity and involving parents and the school community have shown to be more effective (Wang et al., 2015). Few studies, however, have used a structured motivational strategy to increase engagement of students and school communities.
The clustered-randomized controlled trial Juntos Santiago was designed as a multidimensional intervention that incorporates a gamification strategy to increase motivation and participation. The intervention addresses the snacks brought from home, encourages physical activity and active parent and school community participation. All the aspects of the intervention are brought together in a game that provides points, levels and rewards that improve school infrastructure for better nutrition and physical activity. Structural rewards contribute to a sustained effect of the intervention.
The purpose of the Juntos Santiago study is to examine the effectiveness of a multicomponent school-based gamification strategy to reduce the body mass index (BMI), waist circumference (WC) and systolic blood pressure (SBP) in school children in 5th and 6th grade, compared to usual care and a leaflet and designed to prevent obesity.
Intervention
The study is part of the Juntos Santiago project, which will be progressively scaled-up for three years. A pilot will be carried out in three schools during 2017, without a control group. In 2018, the trial will include 12 randomly selected schools; the control group will be randomly selected from schools in the Municipality of Santiago plus 4 schools in a neighbour municipality (Estación Central). In 2019, the trial will expand to include all eligible schools in the Municipality of Santiago and 4000 students in the control group from neighbouring municipalities.
The intervention is based on the socio-ecological model. The intervention is a gamification strategy consisting of four components:
Gamification incentives, including the use of points, levels and rewards, to promote behavioural and structural change in the schools. The gamification strategy bundles the intervention components together.
Healthy challenges. Children will be invited to participate in healthy challenges. They will score points, which will result in progressing into a next level and win rewards at the end of the year. There will be three types of challenges:
Healthy snacks challenge, where children collect points for bringing healthy snacks for school breaks.
Steps challenge, where children and one caretaker are given an activity tracker three times a year for two weeks. Points are collected each time a child or a caretaker surpasses a daily threshold level Activity challenge, where children and their families collect points by uploading pictures of specific healthy activities defined by the research team.
Levels. The intervention will take place throughout the year (8 months from March to November). There will be three levels, each associated with a specific reward. Level 1 is the starting point. Level 2 is planned to be reached by 100% at 4 months of the intervention. Level 3 is planned be reached by 70% towards the end of the intervention year. A new cycle will start in 2019.
Rewards. The intervention includes the following rewards:
An initial reward (Starting Kit). The Starting Kit is a box that includes project souvenirs for students, guidelines on healthy snacks and physical activity for children and their families and 12 teaching modules on healthy behaviours designed for teachers. The Starting Kit is delivered upon enrolment in the trial.
An structural reward (SR) when reaching level 2. This reward will be achieved collectively by all participating classes in one school. The reward will be selected from a closed list and will consist of improvements of the school infrastructure to promote a healthy nutrition and physical activity (e.g. a school garden, playground facilities, climbing wall, shared bicycles, sports equipment).
An activity reward (AR) when reaching level 3. This reward will be achieved by each class and will consist of a fun and healthy activity. For example, the visit of a famous sport player, an outdoor trip, tickets to an amusement park, etc.
Parental involvement. Parents will be involved indirectly by the healthy snacks and directly in the steps and activity challenges. Parents will receive a SMS each time points are awarded.
A web platform will be developed for schools and classes to track progress of their points, levels and rewards. An individual login by each student will allow the student and their families to check the results of the anthropometric measurements and points awarded.
Measurements Intervention measurement Healthy snacks. Healthy snacks will be measured three times per month by a trained team. In packaged snacks, data will be collected using the stock keeping unit (SKU) in the barcode. Non-packaged foods will be divided into predefined categories. A food composition database including the calories, saturated fats, total sugar and salt per 100 grams has been developed for this purpose. Indicators: Mean change in calories, saturated fat, total sugar and salt per 100 grams.
Steps challenge. Steps will be measured using a validated activity tracker for 14 days. The mean daily steps will be measured. Indicator: Mean change in total daily steps.
Activity challenge. The research team will define activities were children and families who complete these activity challenges will collect points. This include activities organized by the Municipality of Santiago (i.e. a City run), healthy activities to do as a family (such as cycling or walking together or having a healthy lunch following predefined guidelines), and class activities organized by the teacher following also predefined guidelines. Students and their families will upload pictures of these activities to the web platform to collect the points. A validation system Given the All uploaded pictures Indicator: Mean change in number of completed activity challenges.
Intermediate variables A self-administered questionnaire will be applied at baseline and month 8. The questionnaire includes validated instruments to assess consumption of fruits and vegetables, unhealthy snacks and moderate and vigorous physical activity (MVPA). Consumption of food and vegetables and unhealthy snacks will be measured using the instrument validated by Lera et al (2015) developed in Chilean children aged 10 to 11 years old.12 Additionally, questions from the Global School Health Survey 2013 developed jointly by the Centre for Disease Prevention (CDC) and the Ministry of Health (MoH).
Physical activity will be measured using the PAQ-C. PAQ-C has shown high validity and reliability in different settings. The study will use the PAQ-C version implemented in Chilean schools by Zuñiga et al (2017).13 Questions from the GSHS 2013 on physical activity will also be included.
Adverse effects The study will monitor the experience of bullying, as a possible adverse effect of the intervention, using two questions from the GSHS 2013 on the frequency of bullying in the past 30 days and type of bullying.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial. The randomization unit will be the schools. The primary outcome will be measured individually, but the effect size will also be calculated at the school level.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Gamification strategyGamification strategy. In 2018, the intervention group are 15 schools from Municipality of Santiago. In 2019, the intervention will cover all eligible schools in the Municipality of Santiago. |
| Control | No intervention | –In 2018, the control group will be 5 randomly selected schools from Municipality of Santiago and 4 schools from Municipality of Estación Central. In 2019, the control group will be 4000 participants chosen from neighboring municipalities |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Students in schools in Santiago in 5th and 6th grade (approximately 10 and 11 years old)
- Willingness to participate in the intervention and measurements
- Able to read Spanish and accurately complete dietary assessments
- Any weight status
Key exclusion criteria (3 listed)
- School not accepting to participate in the study
- Class votes against enrolling in the study
- Caretaker does not grant permission to participate
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 |
|---|---|---|
| Gamification strategyThe intervention is a gamification strategy, including game elements such as points, levels and rewards. Points are scored by completion of healthy challenges, i.e. a healthy snacks challenge, a steps challenge and activity challenge. Intervention takes place for 8 months from Mar to Nov. There will be three levels. Level 1 at baseline, level 2 expected at month 4 by 100% of participants and level 3 expected in month 8 by 70% of participants. A new cycle will start in 2019. Rewards include an initial reward (Starting Kit), a structural reward and an activity reward. The Starting Kit is a box with souvenirs, information for students and teachers. A structural reward, at level 2, will be achieved collectively by all participating classes in one school. It consists of school infrastructure improvements to promote a healthy nutrition and PA (eg. climbing wall, shared bicycles, sports equipment). An activity reward (AR), when reaching level 3, consists of a fun and healthy activity. | Behavioural | Intervention |
Primary outcome
Change in zBMI
Time frame: Measured at baseline and 8 months
Change in zscore of body mass index at 8 months
Change in waist circumference
Time frame: Measured at baseline and 8 months
Change in waist circumference measured using standard protocols at 8 months
3 secondary outcomes
Change in BMI
Time frame: Measured at baseline and 8 months
Change in SBP
Time frame: Measured at baseline and 8 months
Change in DBP
Time frame: Measured at baseline and 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Background: PubMed 21872750Wang YC, McPherson K, Marsh T, Gortmaker SL, Brown M. Health and economic burden of the projected obesity trends in the USA and the UK. Lancet. 2011 Aug 27;378(9793):815-25. doi: 10.1016/S0140-6736(11)60814-3.
- Background: PubMed 20122135Withrow D, Alter DA. The economic burden of obesity worldwide: a systematic review of the direct costs of obesity. Obes Rev. 2011 Feb;12(2):131-41. doi: 10.1111/j.1467-789X.2009.00712.x.
- Background: PubMed 20210677Griffiths LJ, Parsons TJ, Hill AJ. Self-esteem and quality of life in obese children and adolescents: a systematic review. Int J Pediatr Obes. 2010 Aug;5(4):282-304. doi: 10.3109/17477160903473697.
- Background: PubMed 15784668Olshansky SJ, Passaro DJ, Hershow RC, Layden J, Carnes BA, Brody J, Hayflick L, Butler RN, Allison DB, Ludwig DS. A potential decline in life expectancy in the United States in the 21st century. N Engl J Med. 2005 Mar 17;352(11):1138-45. doi: 10.1056/NEJMsr043743.
- Background: PubMed 26966329Correa-Burrows P, Burrows R, Blanco E, Reyes M, Gahagan S. Nutritional quality of diet and academic performance in Chilean students. Bull World Health Organ. 2016 Mar 1;94(3):185-92. doi: 10.2471/BLT.15.161315. Epub 2016 Feb 3.
- Background: PubMed 26249128Garcia-Hermoso A, Marina R. Relationship of weight status, physical activity and screen time with academic achievement in adolescents. Obes Res Clin Pract. 2017 Jan-Feb;11(1):44-50. doi: 10.1016/j.orcp.2015.07.006. Epub 2015 Aug 3.
- Background: PubMed 27432468Oosterhoff M, Joore M, Ferreira I. The effects of school-based lifestyle interventions on body mass index and blood pressure: a multivariate multilevel meta-analysis of randomized controlled trials. Obes Rev. 2016 Nov;17(11):1131-1153. doi: 10.1111/obr.12446. Epub 2016 Jul 19.
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- Individual participant dataSharing planned: Undecided. Data without unique personal identification number will be available to associated researchers
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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.
Sebastián Peña, MD, MSc study chair
Finnish Institute for Health and Welfare
Macarena Carranza, LDN, MSc principal investigator
Municipality of Santiago
Pedro Zitko, MD, MSc study chair
King's College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamification strategy in people with Pediatric Obesity, run by Municipality of Santiago at 2 sites in Chile.
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 4 inclusion and 3 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 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. 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 Macarena Carranza Perez-Tinao, LDN, MSc (+56966227489, mcarranza@munistgo.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in zBMI (time frame: Measured at baseline and 8 months). The study lists 2 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 NCT03459742, which also lists 13 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 9 Jul 2018.