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

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01388205
• Other study ID #: FIT-NUS-10-520
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2011
• Last updated: October 8, 2015
• Start date: April 2011
• Est. completion date: March 2012

Study information

• Verified date: October 2015
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myopia
• Obesity

Intervention

Behavioral:
• Family-based Outdoor program
2 to 3 hour outdoor activities organized in conjunction with National Parks, Singapore

Locations

Country	Name	City	State
Singapore	National University of Singapore	Kent Ridge

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical fitness/Exercise capacity	Physical fitness/Exercise capacity assessed through 6-minutes walking test	Outcome measure will be assessed at baseline and 12 month follow-up visit	No
Secondary	Outdoor time	Time spent outdoors assessed using the WHO Risk factor Questionnaire	Outcome measure will be assessed at baseline and 12 month follow-up visit	No