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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02265432
Other study ID # R -608-000-071-112
Secondary ID
Status Recruiting
Phase N/A
First received October 9, 2014
Last updated November 12, 2015
Start date October 2014
Est. completion date September 2016

Study information

Verified date November 2015
Source National University, Singapore
Contact Falk Mueller-Riemenschneider Falk <falk.mueller-riemenschneider,
Phone +65 66013122
Email falk.mueller-riemenschneider@nuhs.edu.sg
Is FDA regulated No
Health authority Singapore: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test an intervention which uses a personalized mobile-technology based approach that aims to promote physical activity and reduce sedentary behaviour in inactive working Singaporean adults.


Description:

Considering the increasing burden in type 2 diabetes mellitus and other chronic diseases, the promotion of physical activity and reduction of sedentary behavior have an important role to improve population health.

Primarily, potential participants will be identified and recruited among participants from the Singapore Health Study (SHS) 2014 based on pre-specified selection criteria . SHS is a cross-sectional study of adults between 18 and 79 years which is conducted annually to monitor health, health behavior and health determinants among the Singapore general population.

All eligible participants will be randomized with a 1:1 ratio to intervention and control group.

Intervention group participants will receive a personalized mobile-technology based intervention to promote physical activity. It consists of four components:

1. General physical activity educational materials

2. Wearable activity tracking devices to enable the intervention participants to self-monitor their physical activity behavior and receive real-time feedback

3. Access to an online map of Singapore providing location based information about leisure time physical activity opportunities

4. Personalized text messages which include, educational information, tailored theory-based motivational messages, as well as compliance enhancing reminders

Control group participants will receive general physical activity educational materials, identical in content to that of the general educational materials of intervention group participants.

All participants will be assessed at baseline, 6 months and 12 months after the intervention by accelerometry and self-reported questionnaires.


Recruitment information / eligibility

Status Recruiting
Enrollment 74
Est. completion date September 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria:

- Men and women 25 to 65 years of age

- Physically inactive

- Working full-time for at least one more year after inclusion

- Signed written informed consent for the intervention study

- Willing to wear the activity tracker, fitbit all the time every day for 6 months

Exclusion Criteria:

- severe medical conditions prohibiting participation in physical activity

- pregnant women

- insufficient English language skills

- Participants who have already activity tracker device

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
General physical activity educational materials

Device:
Wearable activity tracking devices (fitbit)

Other:
online map

Personalized text messages


Locations

Country Name City State
Singapore National Univeristy of Singapore Singapore

Sponsors (1)

Lead Sponsor Collaborator
Dr Falk Mueller-Riemenschneider

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Other proportion of participants being physical active according to current recommendations (at least 150 minutes of moderate intensity activity or an appropriate equivalent of vigorous activity) 6 months No
Other Recall, use and perceived usefulness of intervention and intervention components 6 months No
Other Knowledge, attitudes and perceived barriers to physical activity 6 months No
Other Quality of life 6 months No
Primary average daily step counts 6 months No
Secondary time spent in minutes per week on moderate- to vigorous- intensity physical activity measured by accelerometer 6 months No
Secondary time spent in sedentary activities per day 6 months No
Secondary level of physical activity(measured by accelerometer and self-report) determined in MET minutes per week 6 months No
Secondary time spent in vigorous-, moderate- and light- intensity activities will be determined. 6 months No
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