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

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.

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

Conditions
-----------------
Myopia, Obesity

Intervention / Treatment
-----------------
* Behavioral: Family-based Outdoor program


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family-based Intervention Arm<br> | Behavioral: Family-based Outdoor program<br>* 2 to 3 hour outdoor activities organized in conjunction with National Parks, Singapore<br>* Other names: Outdoor intervention;|
| No Intervention: Control<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myopia, Outdoor activity, Physical activity, Randomized Controlled Trial, Pedometer, Behavior modification, Obesity