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Trial of a Novel Family-Based Intervention to Increase Outdoor Time and Fitness (FIT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01388205
First Posted: July 6, 2011
Last Update Posted: October 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Saw Seang Mei, National University, Singapore
  Purpose
This study aims to implement a new family-based health behavior community program to increase time spent outdoors and physical activity among Singapore children aged 6 to 12 years in a 1-year randomized clinical trial. 300 children from 250 families will be randomly assigned to either a family-based intervention or no intervention. The family-based intervention comprises structured weekend outdoor activities organized by National Parks and incentives for children to wear a pedometer and increase their daily steps. Families who meet their monthly step and outdoor activity goals will receive a range of prizes and incentives. Both groups will receive brochures on the National Myopia Prevention Program and physical activity. The success of the intervention will be evaluated through light meters, 7-day outdoor diaries, questionnaires documenting outdoor time and myopia; as well as pedometer steps, walking tests, and body mass index. A community-based intervention will be developed to improve the health of Singapore children by increasing outdoor time and physical activity to prevent myopia and obesity.

Condition Intervention Phase
Myopia Obesity Behavioral: Family-based Outdoor program Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Exploratory Randomized Controlled Trial of a Novel Family-Based Intervention to Increase Outdoor Time for the Prevention of Myopia and Increase Physical Activity Among Singapore Youth

Resource links provided by NLM:


Further study details as provided by Saw Seang Mei, National University, Singapore:

Primary Outcome Measures:
  • Physical fitness/Exercise capacity [ Time Frame: Outcome measure will be assessed at baseline and 12 month follow-up visit ]
    Physical fitness/Exercise capacity assessed through 6-minutes walking test


Secondary Outcome Measures:
  • Outdoor time [ Time Frame: Outcome measure will be assessed at baseline and 12 month follow-up visit ]
    Time spent outdoors assessed using the WHO Risk factor Questionnaire


Enrollment: 285
Study Start Date: April 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Family-based Intervention Arm Behavioral: Family-based Outdoor program
2 to 3 hour outdoor activities organized in conjunction with National Parks, Singapore
Other Name: Outdoor intervention
No Intervention: Control

Detailed Description:
To develop, implement, and evaluate a novel incentive-based family intervention to increase time spent outdoors and physical activity among children aged 6 to 12 years in a 1-year randomized controlled trial.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children between 6 and 12 years of age with no known health problems preventing them from staying outdoors or walking for physical activity will be included as long as they are Singapore citizens or permanent residents.
  • Both myopic and non-myopic children will be included

Exclusion Criteria:

  • Children with medical conditions such as Type 1 diabetes, severe asthma, cancer or mental illness will be excluded.
  Contacts and Locations
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): NCT01388205


Locations
Singapore
National University of Singapore
Kent Ridge, Singapore, 119077
Sponsors and Collaborators
National University, Singapore
Investigators
Principal Investigator: Saw Seang Mei, MBBS,PhD National University of singapore, Department of Epidemiology & Public Health
Principal Investigator: Eric Andrew Finkelstein, PhD DUKE NUS Graduate Medical School Singapore
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Saw Seang Mei, Professor of Epidemiology, National University, Singapore
ClinicalTrials.gov Identifier: NCT01388205     History of Changes
Other Study ID Numbers: FIT-NUS-10-520
First Submitted: June 30, 2011
First Posted: July 6, 2011
Last Update Posted: October 12, 2015
Last Verified: October 2015

Keywords provided by Saw Seang Mei, National University, Singapore:
Myopia
Outdoor activity
Physical activity
Randomized Controlled Trial
Pedometer
Behavior modification
Obesity

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases