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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01855776
Other study ID # HSRG10NOV002
Secondary ID
Status Completed
Phase N/A
First received August 8, 2012
Last updated January 3, 2016
Start date May 2013
Est. completion date August 2015

Study information

Verified date January 2016
Source Duke-NUS Graduate Medical School
Contact n/a
Is FDA regulated No
Health authority Singapore: Ministry of Health
Study type Interventional

Clinical Trial Summary

This study aims to assess the uptake, effectiveness, and cost-effectiveness of a scalable walking programme for full-time employees both with and without incentives.


Description:

The first part of this study comprises an in-home face-to-face survey with 950 full-time employees in Singapore. The survey aims to identify what an optimal programme might look like and to quantify the potential uptake of the programme, if offered. Stated preference conjoint analysis, which assesses individual preferences for attributes of specific programmes, will be used.

The second part of this study is a Randomised Controlled Trial (RCT) of a 12-month walking programme. Up to 800 full-time employees will be recruited and allocated to one of four research arms: Control Group, Programme Only Group, Cash Incentive Group and Charitable Incentive Group. Participants in the intervention arms will be asked to track their physical activities using Fitbit Zip, a wireless pedometer, which automatically uploads the data to a custom website. Those in the incentive arms will earn money or raise money for charities if they meet weekly exercise targets. Those in the control and Programme Only groups with receive a weekly payment for participation. Incentives and participation payment will be provided from months 1 - 6, after which they will be withdrawn.

The key outcome variable of the RCT is defined as bouts (in minutes) of moderate to vigorous physical activity ("MVPA bouts") as measured via accelerometry. Data will be collected at baseline and month 6 and 12 assessments.

Findings from the RCT will also be used to determine the cost to employers of implementing each programme and the incremental cost-effectiveness of the incentive programmes compared to the basic programme without incentives. The primary hypotheses are that the basic programme will have lower costs per person than the cash or charity programmes, but that the incentive programmes will be more cost-effective relative to the less expensive and less effective basic programme.


Recruitment information / eligibility

Status Completed
Enrollment 800
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria:

- Full-time employees living in Singapore

- Aged between 21-65

Exclusion Criteria:

- report difficulty doing 10 minutes of aerobic activities without stopping

- report difficulty walking up 10 stairs without stopping

- report difficulty performing basic activities of daily living

- have any medical conditions that limit their ability to walk as a means of physical activity

- self-identify medical conditions that limit ability to walk AND do not have medical consent

- answer 'YES' to any PAR-Q questions

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
Fitbit
Fitbit Zip is a wireless pedometer that tracks steps of participants, and will be offered in conjunction with a tailored website with customized information for participants, employers, and/or charities.
Behavioral:
Cash Incentives
Incentives will be awarded to participants for meeting specified weekly step goals as measured by a pedometer.
Charitable Incentives
Incentives will be awarded to charities selected by participants should the latter meet specified weekly step goals measured by a pedometer.
Other:
Usual Care
The "usual care" programme consists of educational materials designed by the Singapore Health Promotion Board. It includes material on how to stay active, walking programmes, and healthy eating.

Locations

Country Name City State
Singapore Duke-NUS Graduate Medical School Singapore

Sponsors (2)

Lead Sponsor Collaborator
Duke-NUS Graduate Medical School Health Promotion Board, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in MVPA (Moderate-to-Vigorous Physical Activity) bouts of participants from baseline to months 6 and 12 MVPA bouts are defined as the total number of minutes during each 1-week assessment period in which moderate or vigorous activity of at least 8 of 10 consecutive minutes are reached. This will be assessed via the Actigraph GT3XE-Plus Triaxial Activity Monitor.
We will measure "MVPA bouts" at baseline, 6, and 12 months. We hypothesize that participants in the Programme Only, and Incentive groups record more "MVPA bouts" at 6 months compared to baseline. Furthermore, participants in the Incentive groups will record more "MVPA bouts" at 6 months compared to the Control and Programme only groups.
We also measure "MVPA bouts" for all participants at 12 months. We do so to test if the "MVPA bouts" measured at month 6, can be sustained at month 12 when incentives are no longer being provided.
Baseline, 6 and 12 months No
Secondary Change in VO2Max of participants from baseline to months 6, and 12. VO2Max is one of the major parameters to evaluate health and fitness of the cardiovascular system and is widely used for health promotion purposes. VO2Max will also be assessed via the Non Exercise Fitness Test (NEFT); NEFT predicts VO2max based on age, gender, BMI, resting heart rate and self-reported physical activities. Baseline, 6 and 12 months No
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