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Systems-oriented School Healthy Weight Promotion Based on NASA Mission X Campaign

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ClinicalTrials.gov Identifier: NCT03355131
Recruitment Status : Unknown
Verified November 2017 by Hsing-Yu Yang, Mackay Medical College.
Recruitment status was:  Active, not recruiting
First Posted : November 28, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Hsing-Yu Yang, Mackay Medical College

Tracking Information
First Submitted Date  ICMJE November 20, 2017
First Posted Date  ICMJE November 28, 2017
Last Update Posted Date November 30, 2017
Actual Study Start Date  ICMJE February 25, 2016
Estimated Primary Completion Date February 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2017)
Body mass index [ Time Frame: 8-weeks ]
weight status, BMI-Z score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Systems-oriented School Healthy Weight Promotion Based on NASA Mission X Campaign
Official Title  ICMJE Systems-oriented School Healthy Weight Promotion: A Pilot Controlled Intervention Study in Remote Areas School Based on NASA Mission X Campaign
Brief Summary This study assessed the effect of the National Aeronautics and Space Administration's (NASA's) Mission X (MX) program on children's knowledge, attitude, and practice of healthy eating and active living (HEAL) and weight status in rural elementary schools in Taiwan.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pediatric Obesity
Intervention  ICMJE Behavioral: Adapted NASA's Mission X program
8 Weeks Adapted National Aeronautics and Space Administration's (NASA's) Mission X (MX) program
Study Arms  ICMJE
  • Experimental: Adapted NASA's Mission X program
    Adapted NASA's Mission X program for the intervention group
    Intervention: Behavioral: Adapted NASA's Mission X program
  • No Intervention: Mission X Control
    no intervention
Publications * Lin YC, Chen HJ, Wang Y, Min J, Wu HC, Carvajal NA, Yang HY. NASA Mission X Program for Healthy Eating and Active Living among Taiwanese Elementary School Students. J Pediatr Nurs. 2019 Nov - Dec;49:e8-e14. doi: 10.1016/j.pedn.2019.06.016. Epub 2019 Jul 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: November 20, 2017)
245
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 24, 2019
Estimated Primary Completion Date February 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The thirteen public elementary schools in Tamsui, Sanzhi and Shimen Districts, New Taipei City, Taiwan, were the target population. Schools that were in distance within 30 minutes by car from Mackay Medical College were approached. Eight schools agreed to participate. All 3rd and 4th graders of the participating schools were invited to the evaluation program.

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03355131
Other Study ID Numbers  ICMJE 15MMHISO90
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hsing-Yu Yang, Mackay Medical College
Study Sponsor  ICMJE Mackay Medical College
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hsing-Yu Yang, DrPH Mackay Medical College
PRS Account Mackay Medical College
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP