Back to resultsTrial of a Novel Family-Based Intervention to Increase Outdoor Time and Fitness (FIT)
Primary Purpose
Myopia, Obesity
Status
Completed
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Family-based Outdoor program
Sponsored by
About this trial
This is an interventional prevention trial for Myopia focused on measuring Myopia, Outdoor activity, Physical activity, Randomized Controlled Trial, Pedometer, Behavior modification, Obesity
Eligibility 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.
Sites / Locations
- National University of Singapore
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Family-based Intervention Arm
Control
Arm Description
Outcomes
Primary Outcome Measures
Physical fitness/Exercise capacity
Physical fitness/Exercise capacity assessed through 6-minutes walking test
Secondary Outcome Measures
Outdoor time
Time spent outdoors assessed using the WHO Risk factor Questionnaire
Full Information
NCT ID
NCT01388205
First Posted
June 30, 2011
Last Updated
October 8, 2015
Sponsor
National University of Singapore
1. Study Identification
Unique Protocol Identification Number
NCT01388205
Brief Title
Trial of a Novel Family-Based Intervention to Increase Outdoor Time and Fitness
Acronym
FIT
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Obesity
Keywords
Myopia, Outdoor activity, Physical activity, Randomized Controlled Trial, Pedometer, Behavior modification, Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
285 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Family-based Intervention Arm
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Family-based Outdoor program
Other Intervention Name(s)
Outdoor intervention
Intervention Description
2 to 3 hour outdoor activities organized in conjunction with National Parks, Singapore
Primary Outcome Measure Information:
Title
Physical fitness/Exercise capacity
Description
Physical fitness/Exercise capacity assessed through 6-minutes walking test
Time Frame
Outcome measure will be assessed at baseline and 12 month follow-up visit
Secondary Outcome Measure Information:
Title
Outdoor time
Description
Time spent outdoors assessed using the WHO Risk factor Questionnaire
Time Frame
Outcome measure will be assessed at baseline and 12 month follow-up visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saw Seang Mei, MBBS,PhD
Organizational Affiliation
National University of singapore, Department of Epidemiology & Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Andrew Finkelstein, PhD
Organizational Affiliation
Duke-NUS Graduate Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University of Singapore
City
Kent Ridge
ZIP/Postal Code
119077
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
23415616
Citation
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.
Results Reference
derived
Learn more about this trial
Trial of a Novel Family-Based Intervention to Increase Outdoor Time and Fitness
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