NCT03459742

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 9, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 9, 2018

Status Verified

July 1, 2018

Enrollment Period

1.6 years

First QC Date

February 18, 2018

Last Update Submit

July 5, 2018

Conditions

Keywords

ObesityGamificationSchoolsCluster Randomized Trial

Outcome Measures

Primary Outcomes (2)

  • Change in zBMI

    Change in zscore of body mass index at 8 months

    Measured at baseline and 8 months

  • Change in waist circumference

    Change in waist circumference measured using standard protocols at 8 months

    Measured at baseline and 8 months

Secondary Outcomes (3)

  • Change in BMI

    Measured at baseline and 8 months

  • Change in SBP

    Measured at baseline and 8 months

  • Change in DBP

    Measured at baseline and 8 months

Study Arms (2)

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.

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

Interventions

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.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • School not accepting to participate in the study
  • Class votes against enrolling in the study
  • Caretaker does not grant permission to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Estacion Central

Santiago, N/A = Not Applicable, 8320077, Chile

RECRUITING

Santiago

Santiago, N/A = Not Applicable, 8320077, Chile

RECRUITING

Related Publications (13)

  • 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.

    PMID: 21872750BACKGROUND
  • Withrow 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.

    PMID: 20122135BACKGROUND
  • Griffiths 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.

    PMID: 20210677BACKGROUND
  • Olshansky 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.

    PMID: 15784668BACKGROUND
  • Correa-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.

    PMID: 26966329BACKGROUND
  • Garcia-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.

    PMID: 26249128BACKGROUND
  • Oosterhoff 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.

    PMID: 27432468BACKGROUND
  • Wang 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.

    PMID: 25893796BACKGROUND
  • Sobol-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.

    PMID: 23794226BACKGROUND
  • Mei 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.

    PMID: 26931236BACKGROUND
  • Vasques 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.

    PMID: 23363556BACKGROUND
  • Lera 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.

    PMID: 25929365BACKGROUND
  • Zurita-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.

    PMID: 28548189BACKGROUND

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sebastián Peña, MD, MSc

    Finnish Institute for Health and Welfare

    STUDY CHAIR
  • Macarena Carranza, LDN, MSc

    Municipality of Santiago

    PRINCIPAL INVESTIGATOR
  • Pedro Zitko, MD, MSc

    King's College London

    STUDY CHAIR

Central Study Contacts

Macarena Carranza Perez-Tinao, LDN, MSc

CONTACT

Paula Espinoza, LDN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2018

First Posted

March 9, 2018

Study Start

April 9, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 9, 2018

Record last verified: 2018-07

Locations