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

This study is ongoing, but not recruiting participants.
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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Time spent outdoors assessed using the WHO Risk factor Questionnaire


Estimated Enrollment: 300
Study Start Date: April 2011
Estimated Study Completion Date: March 2012
Estimated 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

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Professor Saw Seang Mei/Vice Dean (Research), National University of Singapore
ClinicalTrials.gov Identifier: NCT01388205     History of Changes
Other Study ID Numbers: FIT-NUS-10-520
Study First Received: June 30, 2011
Last Updated: July 1, 2011
Health Authority: Singapore: Domain Specific Review Boards

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

Additional relevant MeSH terms:
Myopia
Obesity
Refractive Errors
Eye Diseases
Overnutrition
 Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013