Ignite Creation Date:
2024-05-06 @ 12:26 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03760393
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2018-11-24
Brief Title:
A Combined HAPA and mHealth Intervention to Reduce Sedentary Behaviour in University Students
Sponsor:
Western University Canada
Organization:
Western University Canada
Study Overview
Official Title:
Using a Combined Health Action Process Approach and mHealth Intervention to Reduce Sedentary Behaviour in University Students - A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Societal changes have resulted in reduced demands to be active and increased daily time spent sitting Sedentary behavior SB has been linked to many health problems such as type 2 diabetes and heart disease University students are a high-risk population for excessive SB Increasing the length and frequency of breaks from sitting and increasing the time spent standing and engaged in light physical activity are ways to decrease SB The purpose of this study is to determine whether combining a Health Action Process Approach-based theory-driven specifically action and coping planning intervention with a tailored text messaging intervention can reduce occupational student sitting time among university students Participants in the intervention group will receive one behavioural counselling session followed by daily tailored text messages over a 6-week period with a focus on encouraging them to reduce their sitting time as a student by increasing their frequency and duration of breaks from sitting as well as time spent standing and engaged in light-intensity physical activity It is expected that university students who receive the planning intervention and tailored text messages will report greater increases in non-sedentary behaviours eg break frequency break duration standing light physical activity than those who do not receive the intervention
Detailed Description:
Using a randomized controlled trial design the purpose of this study will be to examine whether combining a Health Action Process Approach HAPA-based intervention specifically action and coping planning with a tailored text message intervention can reduce occupational student sitting time by increasing frequency and length of breaks from sitting and non-exercise activity thermogenesis NEAT behaviours ie standing light-intensity physical activity among university students A secondary purpose will be to examine the effects of the intervention on participants action planning coping planning and action control regarding reducing their sitting time as a student as well as self-rated work performance and health-related outcomes ie role limitations due to physical health role limitations due to personal or emotional problems emotional well-being and energyfatigue Another secondary objective will be to determine if action and coping planning and action control towards reducing occupational student sitting time are related to actual break behaviour time spent standing and time spent in light-intensity physical activity
If successful participants in the intervention group sedentary intervention group will report greater break frequency and break duration time spent standing and time spent in light-intensity physical activity compared to participants in the control group no treatment In addition it is hypothesized that participants in the intervention group will report greater action and coping planning and action control towards reducing sitting time as a student as well as improved work- and health-related outcomes
This study will employ a prospective 2-group repeated measure randomized controlled trial RCT design Participants will be full-time university andor college students
Potential participants estimated enrolment 112 will be recruited by Andrew Scott Rollo Co-Investigator for this study Participants will be recruited from 1 undergraduate and graduate classes at the University of Western Ontario Professors across faculties at UWO will be contacted via email and asked to a distribute the recruitment poster and study invitation to students in their courses andor b allow study investigators to provide a short presentation during their lecture time The opportunity for students to participate will be posted on their UWO OWL site as well as presented in their class Participants will be instructed to contact the researcher via email andor phone if they wish to participate or receive additional details prior to making a decision as to whether to participate A second recruitment approach will involve recruiting full-time university andor college students through recruitment posters distributed through social media ie Facebook LinkedIn Recruitment posters and brief study details will be posted on social media For social media outlets permission from group administrators will be sought prior to posting social media recruitment materials as applicable As stated previous university students interested in the study will be instructed to contact the researcher via email andor phone to sign up for study participation
At this point of contact an email response will be sent to any interested individual University students who choose to take part in this study will receive a link with serial number authorization code via email that directs them to the Letter of Information electronic Informed Consent and questionnaire for assessment of baseline measurements which will be administered through a third party website called SoSci online survey service After viewing the Letter of Information and indicating that they consent to participate in the study by clicking I agree on the survey participants will be asked to complete a brief demographics questionnaire followed by a questionnaire for baseline assessment of primary and secondary outcomes
Upon completion of the Baseline assessment and prior to intervention delivery all participants will be randomized using computer-generated randomized stratification into either a 6-week HAPA-treatment SB-related planning text messages intervention or waitlisted control no treatment condition
At this point all participants will be sent a specific email outlined below depending on group assignment
In the post-baseline questionnaire EMAIL response sent to intervention participants participants randomly assigned to the intervention group only will be asked to provide a day and time within 3 days of completing the baseline assessment that they would be available to schedule the behavioural counselling session they will receive As a follow-up to electronic consent written consent will be obtained during administration of the behavioural counselling session
In the post-baseline questionnaire EMAIL response sent to control participants they will simply be reminded that they will receive a link to a questionnaire every two week for 8 weeks in their email and will be asked to complete these upon receiving them Participants in the control group will also be asked to SIGN and RETURN the LOIwritten informed consent via email at their earliest convenience
For those in the treatment group the study objective will be to reduce occupational student sitting time by increasing non- sedentary or NEAT behaviours ie increasing break frequency to a break every 30-45 minutes with each break having a duration of 2-4 minutes and increasing their time spent standing and engaged in light- intensity PA Participants randomly assigned to the control group will receive no information or intervention of any kind and will only be asked to complete the outcome questionnaires
At the agreed upon and scheduled time the researcher will deliver the intervention ie implement the appropriate HAPA-based behavioural counselling session involving action and coping planning either in person OR electronically via phone and an online presentation website wwwzohocom only for those randomized into the intervention group The method of delivery will entirely depend on the participants availability preference and whether they live within driving distance of the investigator To ensure equal numbers of local and remote participants two computer-generated random number lists will be created by the lead investigator using an online research randomization program Participants will be asked to complete a second informed consent ie written informed consent at this time
The one-on-one counseling sessions will be delivered by the principal investigator to ensure standardization between participants During the counseling session the researcher will first ask if the participant has any strategies that heshe would like to try or think would be effective As much as possible strategies will be kept as original and specific to the participants lifestyle as possible while still fulfilling the study objectives Upon creation of each strategy the researcher will ask the participant if they think that the strategy they came up with is realistic The number of strategies will also be personalized depending on how the participants baseline measures compare to the objectives of their treatment group This will be done in order to attenuate for any neglectedunused strategies by those with larger differences between baseline and objective values Similarly coping strategies will be created alongside each strategy in order to boost the adherence to the developed strategies When an action plan strategy is developed the researcher will ask the participant what are some challenges you foresee with executing this strategy followed by what do you think is something we can do in order to overcome thisthese challenges This will be done in order to keep the coping strategies personalized to the participants lifestyle Overall the behavioral counseling sessions will take approximately 20 minutes to complete Participants will be given the form with their action plan and coping strategies and told to display it somewhere prominent so they will be reminded of the strategies The principal investigator will conduct the planning interventions in a non-interfering manner by providing brief instructions and then remaining available to answer any questions
All participants in the HAPA-treatment condition will then be entered into a contact list on the text-messaging website called Oh Dont Forget Oh Dont Forget is a Web-based application httpohdontforgetcom that works through Recess Mobile to send messages from a computer to mobile phone numbers that are programmed into the application All participants will begin receiving tailored text messages the day after receiving their one-on-one counseling session Every participant will receive the same daily texts as each other participant in their group with times varying slightly depending on their schedule As planning is an ongoing process participants will be reminded via text message to formulate another set of action and coping plans at the beginning of weeks 3 and 5 Upon completion of the intervention period at 6 weeks participants will be notified that they will no longer be receiving text messages and that the study is completed
After the initial behavioural counseling session ALL participants will be told they will receive a link to a questionnaire assessment of primary and secondary outcomes in their email every 2 weeks for the next 6 weeks ie weeks 2 4 and 6 and to complete the questionnaire the day they receive it Participants will also be told that 2 weeks following the end of the 6-week intervention there will be a follow-up questionnaire week 8 which they will receive and be asked to complete Regardless of group assignment all participants will complete the same outcome measures at Baseline 2 weeks 4 weeks 6 weeks and 2-week follow-up 8 weeks All primary and secondary outcome questionnaires will be completed online and administered through a third party website called SoSci online survey service Participants in the HAPA-treatment condition will also be reminded via text to complete these
The primary outcomes including frequency of breaks length of breaks and NEAT behaviours ie standing light- intensity PA in the occupational domain of study ie as a student will be assessed using subjective self-report approaches Secondary analyses will be performed to examine effects of the intervention on theoretical determinants of behaviour change ie action planning coping planning action control as well as participants perceived work-related outcomes ie self-rated work performance and health-related outcomes ie role limitations due to physical health role limitations due to personal or emotional problems emotional well-being and energyfatigue All primary outcomes will be assessed at four time points baseline 2 4 and 6 weeks and again at a two-week follow-up 8 weeks Action and coping planning and action control towards reducing occupational student sitting time will be assessed at the same time points Secondary outcome variables ie perceived work- and health-related outcomes will be assessed pre- baseline and post-intervention 6 weeks
If successful participants in the intervention group sedentary intervention group will report greater break frequency and break duration time spent standing and time spent in light-intensity physical activity compared to participants in the control group no treatment In addition it is hypothesized that participants in the intervention group will report greater action and coping planning and action control towards reducing sitting time as a student as well as improved work- and health-related outcomes
This study will employ a prospective 2-group repeated measure randomized controlled trial RCT design Participants will be full-time university andor college students
Potential participants estimated enrolment 112 will be recruited by Andrew Scott Rollo Co-Investigator for this study Participants will be recruited from 1 undergraduate and graduate classes at the University of Western Ontario Professors across faculties at UWO will be contacted via email and asked to a distribute the recruitment poster and study invitation to students in their courses andor b allow study investigators to provide a short presentation during their lecture time The opportunity for students to participate will be posted on their UWO OWL site as well as presented in their class Participants will be instructed to contact the researcher via email andor phone if they wish to participate or receive additional details prior to making a decision as to whether to participate A second recruitment approach will involve recruiting full-time university andor college students through recruitment posters distributed through social media ie Facebook LinkedIn Recruitment posters and brief study details will be posted on social media For social media outlets permission from group administrators will be sought prior to posting social media recruitment materials as applicable As stated previous university students interested in the study will be instructed to contact the researcher via email andor phone to sign up for study participation
At this point of contact an email response will be sent to any interested individual University students who choose to take part in this study will receive a link with serial number authorization code via email that directs them to the Letter of Information electronic Informed Consent and questionnaire for assessment of baseline measurements which will be administered through a third party website called SoSci online survey service After viewing the Letter of Information and indicating that they consent to participate in the study by clicking I agree on the survey participants will be asked to complete a brief demographics questionnaire followed by a questionnaire for baseline assessment of primary and secondary outcomes
Upon completion of the Baseline assessment and prior to intervention delivery all participants will be randomized using computer-generated randomized stratification into either a 6-week HAPA-treatment SB-related planning text messages intervention or waitlisted control no treatment condition
At this point all participants will be sent a specific email outlined below depending on group assignment
In the post-baseline questionnaire EMAIL response sent to intervention participants participants randomly assigned to the intervention group only will be asked to provide a day and time within 3 days of completing the baseline assessment that they would be available to schedule the behavioural counselling session they will receive As a follow-up to electronic consent written consent will be obtained during administration of the behavioural counselling session
In the post-baseline questionnaire EMAIL response sent to control participants they will simply be reminded that they will receive a link to a questionnaire every two week for 8 weeks in their email and will be asked to complete these upon receiving them Participants in the control group will also be asked to SIGN and RETURN the LOIwritten informed consent via email at their earliest convenience
For those in the treatment group the study objective will be to reduce occupational student sitting time by increasing non- sedentary or NEAT behaviours ie increasing break frequency to a break every 30-45 minutes with each break having a duration of 2-4 minutes and increasing their time spent standing and engaged in light- intensity PA Participants randomly assigned to the control group will receive no information or intervention of any kind and will only be asked to complete the outcome questionnaires
At the agreed upon and scheduled time the researcher will deliver the intervention ie implement the appropriate HAPA-based behavioural counselling session involving action and coping planning either in person OR electronically via phone and an online presentation website wwwzohocom only for those randomized into the intervention group The method of delivery will entirely depend on the participants availability preference and whether they live within driving distance of the investigator To ensure equal numbers of local and remote participants two computer-generated random number lists will be created by the lead investigator using an online research randomization program Participants will be asked to complete a second informed consent ie written informed consent at this time
The one-on-one counseling sessions will be delivered by the principal investigator to ensure standardization between participants During the counseling session the researcher will first ask if the participant has any strategies that heshe would like to try or think would be effective As much as possible strategies will be kept as original and specific to the participants lifestyle as possible while still fulfilling the study objectives Upon creation of each strategy the researcher will ask the participant if they think that the strategy they came up with is realistic The number of strategies will also be personalized depending on how the participants baseline measures compare to the objectives of their treatment group This will be done in order to attenuate for any neglectedunused strategies by those with larger differences between baseline and objective values Similarly coping strategies will be created alongside each strategy in order to boost the adherence to the developed strategies When an action plan strategy is developed the researcher will ask the participant what are some challenges you foresee with executing this strategy followed by what do you think is something we can do in order to overcome thisthese challenges This will be done in order to keep the coping strategies personalized to the participants lifestyle Overall the behavioral counseling sessions will take approximately 20 minutes to complete Participants will be given the form with their action plan and coping strategies and told to display it somewhere prominent so they will be reminded of the strategies The principal investigator will conduct the planning interventions in a non-interfering manner by providing brief instructions and then remaining available to answer any questions
All participants in the HAPA-treatment condition will then be entered into a contact list on the text-messaging website called Oh Dont Forget Oh Dont Forget is a Web-based application httpohdontforgetcom that works through Recess Mobile to send messages from a computer to mobile phone numbers that are programmed into the application All participants will begin receiving tailored text messages the day after receiving their one-on-one counseling session Every participant will receive the same daily texts as each other participant in their group with times varying slightly depending on their schedule As planning is an ongoing process participants will be reminded via text message to formulate another set of action and coping plans at the beginning of weeks 3 and 5 Upon completion of the intervention period at 6 weeks participants will be notified that they will no longer be receiving text messages and that the study is completed
After the initial behavioural counseling session ALL participants will be told they will receive a link to a questionnaire assessment of primary and secondary outcomes in their email every 2 weeks for the next 6 weeks ie weeks 2 4 and 6 and to complete the questionnaire the day they receive it Participants will also be told that 2 weeks following the end of the 6-week intervention there will be a follow-up questionnaire week 8 which they will receive and be asked to complete Regardless of group assignment all participants will complete the same outcome measures at Baseline 2 weeks 4 weeks 6 weeks and 2-week follow-up 8 weeks All primary and secondary outcome questionnaires will be completed online and administered through a third party website called SoSci online survey service Participants in the HAPA-treatment condition will also be reminded via text to complete these
The primary outcomes including frequency of breaks length of breaks and NEAT behaviours ie standing light- intensity PA in the occupational domain of study ie as a student will be assessed using subjective self-report approaches Secondary analyses will be performed to examine effects of the intervention on theoretical determinants of behaviour change ie action planning coping planning action control as well as participants perceived work-related outcomes ie self-rated work performance and health-related outcomes ie role limitations due to physical health role limitations due to personal or emotional problems emotional well-being and energyfatigue All primary outcomes will be assessed at four time points baseline 2 4 and 6 weeks and again at a two-week follow-up 8 weeks Action and coping planning and action control towards reducing occupational student sitting time will be assessed at the same time points Secondary outcome variables ie perceived work- and health-related outcomes will be assessed pre- baseline and post-intervention 6 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None