|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03459742 |
|
Date of registration:
|
18/02/2018 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Juntos Santiago: Gamification Strategy to Reduce Childhood Obesity in Schools in Santiago de Chile
|
|
Scientific title:
|
A Gamification Strategy to Reduce Childhood Obesity in Santiago Schools: a Cluster Randomized Controlled Trial |
|
Date of first enrolment:
|
April 9, 2018 |
|
Target sample size:
|
12000 |
|
Recruitment status: |
Unknown status |
|
URL:
|
https://clinicaltrials.gov/show/NCT03459742 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Chile
| | | | | | | |
|
Contacts
|
|
Name:
|
Macarena Carranza, LDN, MSc |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Municipality of Santiago |
|
|
Name:
|
Macarena Carranza Perez-Tinao, LDN, MSc |
|
Address:
|
|
|
Telephone:
|
+56966227489 |
|
Email:
|
mcarranza@munistgo.cl |
|
Affiliation:
|
|
|
|
Name:
|
Sebastián Peña, MD, MSc |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Finnish Institute for Health and Welfare |
|
|
Name:
|
Pedro Zitko, MD, MSc |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
King's College London |
| | |
|
Key inclusion & exclusion 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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Pediatric Obesity
|
|
Intervention(s)
|
|
Behavioral: Gamification strategy
|
|
Primary Outcome(s)
|
|
Change in zBMI
[Time Frame: Measured at baseline and 8 months]
|
|
Change in waist circumference
[Time Frame: Measured at baseline and 8 months]
|
|
Secondary Outcome(s)
|
|
Change in DBP
[Time Frame: Measured at baseline and 8 months]
|
|
Change in SBP
[Time Frame: Measured at baseline and 8 months]
|
|
Change in BMI
[Time Frame: Measured at baseline and 8 months]
|
|
Secondary ID(s)
|
|
Secc. 2da. 11058
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|