Clinical trial NCT01388205: Trial of a Novel Family-Based Intervention to Increase Outdoor Time and Fitness
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myopia
Obesity
Keywords: Myopia
Outdoor activity
Physical activity
Randomized Controlled Trial
Pedometer
Behavior modification
Obesity
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2011-07-06
Enrollment: 285
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Physical fitness/Exercise capacity
timeFrame: Outcome measure will be assessed at baseline and 12 month follow-up visit
Secondary outcomes:
measure: Outdoor time
timeFrame: Outcome measure will be assessed at baseline and 12 month follow-up visit
Other outcomes:
Locations:
city: Kent Ridge
country: Singapore
facility: National University of Singapore
Study officials:
affiliation: National University of singapore, Department of Epidemiology & Public Health
name: Saw Seang Mei, MBBS,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke-NUS Graduate Medical School
name: Eric Andrew Finkelstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.