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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by National University, Singapore.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National University, Singapore
ClinicalTrials.gov Identifier:
NCT01388205
First received: June 30, 2011
Last updated: July 1, 2011
Last verified: July 2011

June 30, 2011
July 1, 2011
April 2011
March 2012   (final data collection date for primary outcome measure)
Physical fitness/Exercise capacity [ Time Frame: Outcome measure will be assessed at baseline and 12 month follow-up visit ] [ Designated as safety issue: No ]
Physical fitness/Exercise capacity assessed through 6-minutes walking test
Same as current
Complete list of historical versions of study NCT01388205 on ClinicalTrials.gov Archive Site
Outdoor time [ Time Frame: Outcome measure will be assessed at baseline and 12 month follow-up visit ] [ Designated as safety issue: No ]
Time spent outdoors assessed using the WHO Risk factor Questionnaire
Same as current
Not Provided
Not Provided
 
Trial of a Novel Family-Based Intervention to Increase Outdoor Time and Fitness
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Myopia
  • Obesity
Behavioral: Family-based Outdoor program
2 to 3 hour outdoor activities organized in conjunction with National Parks, Singapore
Other Name: Outdoor intervention
  • Experimental: Family-based Intervention Arm
    Intervention: Behavioral: Family-based Outdoor program
  • No Intervention: Control
Finkelstein EA, Tan YT, Malhotra R, Lee CF, Goh SS, Saw SM. A cluster randomized controlled trial of an incentive-based outdoor physical activity program. J Pediatr. 2013 Jul;163(1):167-72.e1. doi: 10.1016/j.jpeds.2013.01.009. Epub 2013 Feb 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
March 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
6 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01388205
FIT-NUS-10-520
Yes
Professor Saw Seang Mei/Vice Dean (Research), National University of Singapore
National University, Singapore
Not Provided
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
National University, Singapore
July 2011

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