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Clinical Trials/NCT01388205
NCT01388205CompletedPhase 3

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

National University of Singapore1 site in 1 country285 target enrollmentStarted: April 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
285
Locations
1
Primary Endpoint
Physical fitness/Exercise capacity

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
6 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Family-based Intervention Arm

Experimental

Intervention: Family-based Outdoor program (Behavioral)

Control

No Intervention

Outcomes

Primary Outcomes

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 Outcomes

  • Outdoor time(Outcome measure will be assessed at baseline and 12 month follow-up visit)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Saw Seang Mei

Professor of Epidemiology

National University of Singapore

Study Sites (1)

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