Home » Trials » SLCTR/2021/009


Effectiveness of motivational drivers developed based on theoretical constructs and delivered through a mobile application to promote daily physical activity among sedentary working adults of Colombo Municipal Council area

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SLCTR Registration Number

SLCTR/2021/009


Date of Registration

30 Mar 2021

The date of last modification

Mar 30, 2021



Application Summary


Scientific Title of Trial

Effectiveness of motivational drivers developed based on theoretical constructs and delivered through a mobile application to promote daily physical activity among sedentary working adults of Colombo Municipal Council area


Public Title of Trial

Effectiveness of motivational drivers developed based on theoretical constructs and delivered through a mobile application to promote daily physical activity among sedentary working adults of Colombo Municipal Council area.


Disease or Health Condition(s) Studied

Motivation, Active lifestyle


Scientific Acronym

None


Public Acronym

None


Brief title

Improving physical activity among sedentary working adults through motivational drivers delivered through a mobile app.


Universal Trial Number

U1111-1261-5053


Any other number(s) assigned to the trial and issuing authority

EC-19-166


Trial Details


What is the research question being addressed?

Are motivational drivers developed through theoretical constructs and delivered though a mobile application effective in promoting daily physical activity among sedentary working adults in the Colombo Municipal Council area?


Type of study

Interventional


Study design

Allocation

Non-randomized controlled trial


Masking

Masking not used


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Prevention


Study Phase

Not Applicable


Intervention(s) planned

Study design: A quasi-experimental study Study setting: Banking sector in the Colombo Municipal Council (CMC) area Sampling method:
Four groups will be randomly assigned for the study. Initially, four Banks (with a minimum workforce of 100) which are located geographically apart in the CMC area of the district of Colombo, where there had not previously been any exposure to health promotion program will be selected purposively for the study. This selection will be made while ensuring that the four banks are comparable with each other as much as possible by gender and size of its workforce.

Next, the four bank settings will be randomly allocated (using a random number table) to receive one of the three interventions (intervention groups 1-3) or to receive none of the interventions (control group). Thereafter, within each setting, the required sample size (n=61) will be obtained for the study. For this purpose, the list of banking officers included in the employment register will be taken as the sampling frame, from which those fulfilling the eligibility criteria will be identified using systematic sampling. After selecting one person randomly from the first five persons enlisted in the register, every other person will be selected until the required sample size is achieved. Thereafter, each will be invited to participate in the study.

Intervention group 1: This group will receive the following: • Education module (this would enable all participants to acquire knowledge and skills required for being active throughout the day. Knowledge on the benefits gained by being active, recommendations on physical activity level to be achieved per week, commonly adopted daily activities and their approximate metabolic equivalents (MET) values and activities recommended for sedentary workers will be given in non-personalized video presentations, question and answer sessions, quiz and online reading material). • Non-personalized, pop-up motivational messages every morning • One health message • One reminder to access the educational material/ interactive videos uploaded on physical activity. Participants will receive 2-3 pop-up messages every day at fixed times of the day. Also, these messages will be displayed whenever the user is switching on the phone or shifting to active mode, so as to ensure that the message is seen by the user. All other features of the mobile application will be disabled from use.

Intervention group 2: This group will receive the following: • Education module • Non-personalized pop-up motivational messages (in text or graphical form) • Information message on their activity level, such as step count, sedentary time, active time, travel time, etc. (captured through built-in accelerometer) Participants will receive 2-3 pop-up messages every day.

Intervention group 3: This group will receive the following: • Education module • Personalized pop-up motivational messages (in text or graphical form). Personalized messages are packaged as a series to facilitate the motivational process by providing feedback and incorporating user inputs with background data from inbuilt sensors for personalized motivational messages. Participants will receive 2-3 pop-up messages every day at fixed times of the day. The messages will be personalized according to age and gender of the user, daily routine specific for the user and the amount of activity done in the previous day by the user. Also, these messages will be displayed whenever the user switches on the phone or when shifting to active mode, so as to ensure that the message is seen by the user. • Feedback on their activity level, such as step count, sedentary time, active time, travel time, etc. (captured through accelerometer and GPS data) Participants will receive this feedback throughout the day (on demand). Apart from the physical activity (PA) information, the user will receive daily, weekly and monthly summaries of PA levels. Based on the feedback, alternatives/ suggestions would also be made on further options available to achieve the recommended physical activity for a given day. The application will also facilitate setting goals for each week, planning activities per day and effective modification of daily routine to achieve the recommended physical activity level.

Control group: This group will not have access to the newly developed mobile application through smartphone.

Intervention will continue for a period of six months.


Inclusion criteria

Adults (male and female) between 18-50 years of age currently employed in State Banks in the Colombo District,

Employed full time (for a minimum period of five years) as Bank Officers engaged in sedentary work (seated at least for 6 hours per day during work on more than five days a week)

Participants who own a smartphone (mobile phones comprising multi-purpose computing devices, equipped with hardware capabilities and extensive mobile operating systems, which facilitate software, internet & web browsing and multimedia functionality (including music, video, camera and gaming), alongside core phone functions such as voice calls and text messaging) and who spend more than 90 minutes per day on communication/ internet browsing/ social media other than for designated official work on a daily basis including minimum frequency of usage of 2 times per hour on average.

Not engaged in any regular recreational physical activity (e.g. sport activity, exercise session or brisk walking done once a week or more) at present and during last one year


Exclusion criteria

Exclusions: • Conditions/diseases that have restrictions on physical activities (e.g. recent myocardial infarct, diagnosed angina, arthritis or backache, musculoskeletal injury) • On a strict diet control program • Pregnancy and lactation
• Previously engaged in physical activity programmes delivered via mobile application • Currently using a mobile application for self-monitoring of physical activity and/or registered for e-health services



Primary outcome(s)

1.

Scores of the BREQ-3 - The Behavioral Regulation in Exercise Questionnaire. The mean difference between different time intervals would be compared across four groups.

[

At baseline and at end of 3 months and 6 months of the intervention

]

Secondary outcome(s)

1.

IPAQ-International Physical Activity Questionnaire score will be used to calculate metabolic equivalents value. This would allow us to calculate the proportion of participants who meet an adequate-level and inadequate-level of physical activity.

[

At baseline and at end of 3 months and 6 months of the intervention

]

Target number/sample size

244 (61 in each arm - 4 groups)


Countries of recruitment

Sri Lanka


Anticipated start date

2021-04-15


Anticipated end date

2021-10-15


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

University of Colombo


Regulatory approvals

None



State of Ethics Review Approval


Status

Approved


Date of Approval

2020-10-15


Approval number

EC-19-166


Details of Ethics Review Committee

Name: Ethics Review Committee
Institutional Address:Faculty of Medicine, University of Colombo, PO BOX 271, Kynsey Road, Colombo 08, Sri Lanka
Telephone:0112695300
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Upula Vishwamithra Amarasinghe
Monitoring and Evaluation Officer
Food and Agriculture Organization of the United Nations, UN Compound, 202, Bauddhaloka Mawatha, Colombo 7, Sri Lanka.
+94112588537 – ext: 2006
+94 (0) 7696 17867
+94112587990
vishwaupula@gmail.com

Contact Person for Public Queries

Prof Carukshi Arambepola
Professor in Community Medicine
Department of Community Medicine Faculty of Medicine University of Colombo No. 25, Kynsey Road, Colombo 8

0775579770

carukshi@commed.cmb.ac.lk


Primary study sponsor/organization

UNIVERSITY OF COLOMBO

University of Colombo, College House, 94, Kumaratunga Munidasa Mawatha, Colombo 00700
0112 581 835

acpbuoc@gmail.com
https://cmb.ac.lk

Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results