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Juntos Santiago: Gamification Strategy to Reduce Childhood Obesity in Schools in Santiago de Chile

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ClinicalTrials.gov Identifier: NCT03459742
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : July 9, 2018
Sponsor:
Collaborators:
Delivery Associates
Bloomberg Philanthropies
University of Chile
Pontificia Universidad Catolica de Chile
Ministry of Health, Chile
Information provided by (Responsible Party):
Municipality of Santiago

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.


Condition or disease Intervention/treatment Phase
Pediatric Obesity Behavioral: Gamification strategy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: A Gamification Strategy to Reduce Childhood Obesity in Santiago Schools: a Cluster Randomized Controlled Trial
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Intervention
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

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.


No Intervention: Control
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



Primary Outcome Measures :
  1. Change in zBMI [ Time Frame: Measured at baseline and 8 months ]
    Change in zscore of body mass index at 8 months

  2. Change in waist circumference [ Time Frame: Measured at baseline and 8 months ]
    Change in waist circumference measured using standard protocols at 8 months


Secondary Outcome Measures :
  1. Change in BMI [ Time Frame: Measured at baseline and 8 months ]
    Change in body mass index (weight/height squared) at 8 months. Weight and height will be combined to report BMI in kg/m^2

  2. Change in SBP [ Time Frame: Measured at baseline and 8 months ]
    Change in systolic blood pressure at 8 months

  3. Change in DBP [ Time Frame: Measured at baseline and 8 months ]
    Change in diastolic blood pressure at 8 months



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459742


Contacts
Contact: Macarena Carranza Perez-Tinao, LDN, MSc +56966227489 mcarranza@munistgo.cl
Contact: Paula Espinoza, LDN 958618352 pespinozac@munistgo.cl

Locations
Chile
Estacion Central Recruiting
Santiago, N/A = Not Applicable, Chile, 8320077
Contact: Valeska Müller    0974212849    vmuller@munistgo.cl   
Sub-Investigator: Valeska Müller, LDN         
Sub-Investigator: Espinoza Paula, LDN         
Santiago Recruiting
Santiago, N/A = Not Applicable, Chile, 8320077
Contact: Valeska Müller, LDN    +56974212849    vmuller@munistgo.cl   
Contact       vmuller@munistgo.cl   
Sub-Investigator: Valeska Müller, LDN         
Sub-Investigator: Espinoza Paula, LDN         
Sponsors and Collaborators
Municipality of Santiago
Delivery Associates
Bloomberg Philanthropies
University of Chile
Pontificia Universidad Catolica de Chile
Ministry of Health, Chile
Investigators
Study Chair: Sebastián Peña, MD, MSc National Institute for Health and Welfare, Finland
Principal Investigator: Macarena Carranza, LDN, MSc Municipality of Santiago
Study Chair: Pedro Zitko, MD, MSc King's College London

Publications:

Responsible Party: Municipality of Santiago
ClinicalTrials.gov Identifier: NCT03459742     History of Changes
Other Study ID Numbers: Secc. 2da. 11058
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data without unique personal identification number will be available to associated researchers

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Municipality of Santiago:
Obesity
Gamification
Schools
Cluster Randomized Trial

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms