Park Prescription Trial

Healthy Clinical Trial

Official title:

Park Prescription Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615392
• Other study ID #: Park Prescription Trial
• Status: Completed
• Phase: N/A
• First received: November 23, 2015
• Last updated: June 27, 2017
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the effectiveness of prescribing park use (i.e., ''Park Prescription'') to insufficiently active individuals. It is hypothesized that Park Prescription will motivate the target population to increase physical activity and thereby improve their physical and mental health.

Description:

BACKGROUND: There are substantial international research findings supporting the role that natural environments play in enhancing human health and the prevention of chronic diseases. Also, there is evidence highlighting the (cost-) effectiveness of prescribing physical activity to promote one's physical activity and health. However, there is a lack of methodologically rigorous studies that have looked into the effectiveness of combining these two promising approaches; i.e., physical activity prescription with a focus on the use of parks and green spaces: Park Prescription.

AIMS: This Randomized Controlled Trial (RCT) will investigate the concept of Park Prescription as a health promoting intervention for individuals. The primary objective is to investigate the effectiveness of a park prescription interventions to increase participant's time spent in moderate to vigorous physical activity (MVPA). Main secondary objectives are to assess; A) improvement in physical health (e.g., blood sugar and blood pressure) and health behaviour (e.g., sitting time); B) improvement in mental health (e.g., quality of life); 3) intervention implementation fidelity and the association with park use and perceived study participant satisfaction.

METHODOLOGY: Participants aged between 40 and 65 years will be recruited from the Singapore Population Health Community Screening Programme conducted by Alexandra Health Pte Ltd. They will be randomly assigned to one of the following two arms; 1) park prescription + participation in a weekly structured physical activity program conducted in the park, and 2) control group. Participants will be enrolled in the study for a period of 6 months. They will have to complete a baseline assessment, 3-month and 6-month follow-up. The investigators aim to recruit 80 participants in each arm, making a total of 160 study participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

Subjects must meet all of the inclusion criteria as listed below to participate in the study.

Study participants must:

1. be not currently sufficiently active (less than 150 minutes per week of exercise);

2. complete and pass the PAR-Q+*;

3. have a blood pressure of less or equal to (<=) 139 mmHG (systolic) over less or equal to (<=) 89 mmHG (diastolic);

4. have fasting glucose levels of less or equal to (<=) 6.0 mmol/l);

5. be Singaporean or Permanent Residents;

6. be able to write and read;

7. provide informed consent.

Exclusion Criteria:

All subjects meeting any of the following exclusion criteria will be excluded from participation:

1. pregnant women;

2. people who have severe medical conditions prohibiting participation in physical activity as assessed by the PAR-Q (including, heart disease, lung disease, diabetes);

3. people who have a blood pressure of >139 mmHG (systolic) over >89 mmHG (diastolic);

4. people who have fasting glucose levels of >6.0 mmol/l);

5. those with physical disabilities or lower limb disorders.

• The Physical Activity Readiness Questionnaire (PAR-Q) is a self-guided, nine question screening tool that can quickly identify conditions or risk factors that require further assessment before engaging in physical activity. See: British Columbia Ministry of Health Department of National Health and Welfare: Physical Activity Readiness Questionnaire. Canada: 1992.For the current study, we are using an amended version of the PAR-Q.

The PAR-Q+ also includes an additional section to formally assess subjects' age, whether they have physical disabilities or lower limb disorders, and their physical activity status.

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Park Prescription
Please refer to the information included in the arm description.

Locations

Country	Name	City	State
Singapore	Khoo Teck Puat Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
National University, Singapore	Khoo Teck Puat Hospital, National Parks Board, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hours/week spent in Moderate to Vigorous Physical Activity (MVPA) assessed objectively with accelerometry		At 6 months follow-up
Secondary	Fasting glucose levels (mmol/l)		At 6 months follow-up
Secondary	Total cholesterol (mmol/l)		At 6 months follow-up
Secondary	LDL (mmol/l)		At 6 months follow-up
Secondary	HDL (mmol/l)		At 6 months follow-up
Secondary	Triglycerides (mmol/l)		At 6 months follow-up
Secondary	Blood pressure (mmHG)		At 6 months follow-up
Secondary	Body Mass Index (kg/m^2)		At 6 months follow-up
Secondary	Waist circumference (cm)		At 6 months follow-up
Secondary	Hours/week spent in Moderate to Vigorous Physical Activity (MVPA) assessed by self-report		At 6 months follow-up
Secondary	Hours/week spent in sedentary behaviour assessed by self-report		At 6 months follow-up
Secondary	Psychological distress assessed with Kessler-10		At 6 months follow-up
Secondary	Physical and mental health functioning assessed with SF-12		At 6 months follow-up